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The increasing prevalence of chronic respiratory conditions such as asthma and post-COVID complications has made inhalers indispensable in healthcare. With their efficient drug delivery and ease of use, inhalers are pivotal in managing respiratory ailments. However, ensuring the sterility and stability of the medication contained within these devices is critical to their effectiveness and safety. Vacuum decay technology offers an advanced solution for detecting microscopic leaks, securing package integrity, and meeting stringent regulatory standards.

Inhalers: Applications and Challenges

Inhalers cater to diverse needs, delivering medications in dry-powder or soft mist formulations. Their applications are expanding beyond traditional respiratory treatments to manage allergies, infections, and other conditions. Despite their utility, manufacturers face challenges such as maintaining sterility, preventing contamination, and ensuring the proper functionality of container closure systems. Any compromise in these areas can affect patient safety and drug efficacy, underscoring the need for rigorous quality control measures.

Why Is CCI Testing of Inhalers Important?

Container Closure Integrity testing (CCIT) is a critical requirement for inhaler production. Regulatory authorities, including the FDA, mandate robust CCI assessments to detect potential breaches in packaging. These breaches could lead to contamination, reduced medication potency, or risks to patient safety.

For inhalers, CCI testing must confirm that the container closure system effectively protects the medication from external factors such as moisture, oxygen, and microbial ingress. The importance of this testing cannot be overstated, as the sterility and quality of each dose directly impact therapeutic outcomes.

CCI Testing Using VeriPac Vacuum Decay Technology

The VeriPac Vacuum Decay Technology, compliant with ASTM F2338 standards, is an innovative, deterministic, and non-destructive method for detecting microscopic leaks in inhaler packaging. This technology is adaptable to various packaging types, including rigid and flexible containers, making it a versatile solution for the pharmaceutical industry.

The VeriPac Vacuum decay technology operates through a straightforward yet highly effective process. First, the inhaler or its primary packaging is placed within a testing chamber, which can be designed to accommodate both rigid and flexible containers. Once secured, a controlled vacuum level is applied to the chamber. A highly sensitive pressure transducer then measures any decay in the vacuum level. This decay may occur due to gas escaping from the package or liquid vaporizing within it, both of which indicate potential leaks. This precise and reliable method can detect microscopic leaks as small as or below the industry standard of 5 microns, ensuring the highest level of package integrity.

Benefits of the VeriPac Series

The VeriPac Series stands out as a reliable solution for inhaler CCI testing, offering several advantages:

• High Sensitivity: Detects microscopic leaks with precision.
• Non-Destructive: Allows manufacturers to test without damaging the product.
• Adaptability: Suitable for both rigid and flexible packaging formats.
• Efficiency: Provides fast, accurate, and quantitative results.

Vacuum decay technology has revolutionized the approach to container closure integrity testing for inhalers. By adopting the VeriPac Series, manufacturers can ensure product safety, regulatory compliance, and patient satisfaction. As the demand for inhalers continues to grow, robust CCI testing will remain integral to delivering safe and effective treatments.

Embracing this advanced technology not only mitigates risks but also elevates the standards of pharmaceutical packaging quality, securing the trust of healthcare providers and patients alike.

Ensuring sterility in medical device packaging is essential to patient safety and product efficacy. Sterility prevents contamination that could compromise device performance or patient health. As packaging technologies advance and regulatory requirements grow stricter, ensuring seal integrity has become a critical focus for manufacturers.

Medical device packaging has evolved significantly to meet the demands of modern healthcare. The growing reliance on single-use devices has heightened the need for robust and sterile packaging solutions. At the same time, sustainability has emerged as a key consideration, prompting the adoption of eco-friendly materials that require precise packaging techniques. Regulatory bodies like International Organisation for Standardisation (ISO) and Food and Drug Administration (FDA) are placing increased emphasis on packaging performance, particularly in seal integrity, to ensure compliance with global standards. Additionally, innovations in packaging materials, such as flexible films and high-barrier layers, enhance device protection but also necessitate advanced package integrity testing methods to verify their effectiveness.

The Importance of Seal Integrity in Medical Device Packaging

Seal integrity is the foundation of medical device packaging, ensuring sterility is preserved throughout the product's shelf life and until its use. A reliable seal acts as a protective barrier against contaminants such as bacteria, dust, and moisture. Any compromise in the seal can lead to sterility failures, posing serious risks to patient health. Regulatory compliance underscores the importance of robust seal integrity testing, as manufacturers must demonstrate the reliability of their packaging processes to meet global standards. Seal integrity also directly impacts product longevity, ensuring the device remains safe and effective over time. Ultimately, maintaining seal quality is crucial to uphold patient safety, as a breach in packaging could result in infections or device malfunctions.

Seal Integrity Testing of Medical Device Packaging Using Airborne Ultrasound Technology

Airborne Ultrasound technology provides a precise and non-invasive method for evaluating the seal quality of pouches and flexible packaging. This advanced seal integrity test is compatible with a wide range of packaging materials, including Tyvek®, paper, foil, film, aluminum, plastic, and poly. As a non-destructive testing technique, it ensures the package remains intact while delivering accurate and reliable results. Economical and highly efficient, Airborne Ultrasound is an ideal solution for assessing the seal integrity of finished pouches, making it both cost-effective and practical for various applications. Recognized as a standard by the FDA, it was granted the ASTM Test Method F3004–13 designation in 2013 for seal quality testing.

Airborne Ultrasound technology operates by propagating ultrasonic waves through the seal area of the package as it passes over a sensor head. These waves interact with the materials, reflecting sound signals. When the seal is free of defects, the ultrasonic waves are transmitted efficiently. However, in the presence of a defect, signal strength is significantly reduced or completely eliminated, enabling precise defect detection. The level of sound reflection and transmission is influenced by the acoustic difference between the materials within the seal. The greater the acoustic contrast, the more sound is reflected, allowing for detailed analysis of the seal’s integrity.

Seal integrity testing using Airborne Ultrasound Technology represents a leap forward in ensuring the safety and reliability of medical device packaging. By adopting this advanced, non-destructive testing method, manufacturers can meet stringent regulatory requirements, ensure product longevity, and protect patient safety. In a rapidly evolving healthcare landscape, integrating technologies like Airborne Ultrasound into packaging processes is essential for maintaining high standards and delivering trustworthy medical devices.

Since the number of complex medical devices is rising, including implantable sensors, infusion pumps, and diagnostic instruments, package integrity becomes more important. Most of these need to be handled with utmost care in order not to get contaminated, especially if they are sensitive to moisture and oxygen. Package integrity testing would, therefore, be an optimal way for determining whether the packaging would retain a sterile barrier or not.

Challenges in Medical Device Packaging

Packaging medical devices also incurs numerous environmental challenges. Moisture-sensitive equipment presents the likelihood of being exposed to wet conditions, increasing the susceptibility to compromised product integrity and subsequent health risks. Some of the key issues are as follows:

• Environmental Exposure: Moisture, dust, and other contaminants can degrade device performance if packaging fails.
• Regulatory Compliance: Strict regulations require rigorous testing to ensure packages are sealed and sterile.
• Non-Destructive Testing Requirements: For sensitive devices, packaging tests must be non-destructive, so sample integrity remains intact.

These challenges necessitate advanced testing solutions that can provide accurate, repeatable results without harming the package.

Why is Package Integrity Testing of Medical Device Packaging Important?

Package integrity testing of medical device packaging is crucial because it verifies the packaging’s ability to maintain a sterile barrier, safeguarding the device from contamination and environmental exposure throughout its shelf life. For moisture-sensitive devices, even a microscopic breach can allow microbial ingress or moisture, compromising device safety and efficacy. This testing process helps manufacturers meet stringent FDA and ISO standards, reduce product recalls, and uphold the highest safety standards. Ultimately, package integrity testing not only protects patients but also reinforces a company’s commitment to quality, ensuring that medical devices arrive in pristine condition, ready for safe use.

Ensuring Package Integrity with VeriPac Vacuum Decay Technology

PTI’s VeriPac container closure integrity testing (CCIT) method offers a non-destructive alternative to traditional leak testing methods such as water bath, bubble leak, or blue dye tests. VeriPac systems can be used for integrity testing of Tyvek and other porous packaging, ensuring the product meets regulatory and consumer standards for quality. Introduced in 2003 as an ASTM test method, this vacuum decay technology was initially developed for testing Tyvek-lidded trays.

The VeriPac system works by connecting its leak testers to a test chamber designed to hold the package sample. A vacuum is applied to the package within this chamber, and the level of vacuum, along with any changes in vacuum over a set test duration, is monitored using single or dual vacuum transducer technology. By tracking changes in both absolute and differential vacuum levels, the system can detect leaks or defects in the package with high accuracy.

• Non-destructive test method that ensures quantitative test results
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process

The pharmaceutical biologics are the newest class of drugs requiring complex and sensitive handling. Obtained from living organisms, biologics like vaccines and antibodies have a high susceptibility to degradation if exposed to contaminants or environmental changes. Packaging of the drug must, therefore, be air-tight to meet safety and efficacy requirements; thus, there is a need for Container Closure Integrity testing (CCIT). Traditional testing methods are mainly destructive. In that case, biologics safety cannot be ensured. However, the industry is shifting towards non-destructive, deterministic, highly accurate and reliable techniques of testing.

Overview of Biologics Packaging

Biologics are sensitive to temperature, light, and contaminants, hence requiring specialty packaging to ensure shelf-life stability. Glass vials, prefilled syringes, and ampoules are some common formats with individual specifications to produce a sterile barrier. Because biologics are easily affected, the packaging needs to maintain a completely sealed environment.

Why CCI Testing Is Important for Biologics

Biologics have even the slightest impurities reduce the product's effectiveness and make it potentially unsafe. Here's why CCI testing is so important for biologics:

• Ensures Safety and Effectiveness: Biologics degrade very fast when exposed to air or moisture or any contaminants. Appropriate CCI testing ensures that the packaging is sealed.
• Regulatory Compliance: Regulatory agencies like FDA require accurate, numerical CCI testing of biologics' packaging. Noncompliance with these requirements may even lead to recalls and, therefore, harm the reputation of a manufacturer.
• Extended Shelf Life: Biologics are expensive to produce, so obtaining the CCI results in an extended shelf life with less waste and financial losses.
• Minimal Risk to Patient: Strong packaging ensures a patient does not receive a compromised product, therefore ensuring safety for the patient.

Techniques for Ensuring Container Closure Integrity

For biologics, non-destructive and reliable methods of testing are preferred over traditional techniques. Here’s an introduction to two advanced CCI methods widely used in the industry:

1. Helium Leak Detection

Helium Leak Detection (HLD) is a precise method for identifying tiny leaks in sealed systems, using helium as a tracer gas. Helium’s small atomic size and inert, non-flammable nature make it ideal for penetrating leaks, allowing accurate leakage rate measurements. Its benefits include lower weight, cost-effectiveness, and availability in various forms, setting it apart from alternatives like hydrogen.

The technique operates on mass spectrometry principles, where ionized helium ions are accelerated and directed through a magnetic field, ensuring only helium ions reach the detector. This ion current, converted to an electric current, is then displayed as a leak rate. Compared to traditional methods like vacuum bubble and dye tests, helium testing offers highly accurate, quantitative assessments across diverse packaging conditions and lifecycle stages.

With sensitivity levels as low as 1×10-12 l/s, helium leak testing enables unmatched detection of minute leaks, supporting comprehensive package integrity evaluations.

2. MicroCurrent HVLD Technology

It is one of the most advanced non-destructive, non-invasive Container Closure Integrity Testing (CCIT) methods-PTI's MicroCurrent HVLD technology-that produces very effective CCIT in any range of application, whether it be pre-filled syringes, vials, cartridges, ampoules, Blow-Fill-Seal containers, bottles, and pouches. This technology proves to be effective for leak detection of liquid-filled parenteral products. Applications include low-conductivity products, such as sterile WFI and large molecule protein-based products.

In this process, electrode probes scan the sealed container to detect any potential leaks. A variation in current flow helps identify container defects and pinpoint their location. Notably, MicroCurrent HVLD technology operates with approximately 50% lower voltage, exposing both the product and its environment to less than 5% of the voltage used in conventional HVLD methods. This makes it one of the most effective CCI solutions for parenteral and biologic products.

The complexity and sensitivity of biologics have driven the industry toward advanced, non-destructive CCI testing methods. MicroCurrent HVLD and Helium Leak Detection provide the precision, reliability, and non-invasive testing needed to ensure that biologics remain safe, effective, and compliant with regulatory standards. These techniques not only help biologics manufacturers meet regulatory requirements but also support the safe delivery of biologics to patients, ensuring the highest product integrity.

In the pharmaceutical, biotechnology, and medical device industries, the integrity of product packaging is critical to ensure product safety and efficacy. Container Closure Integrity (CCI) refers to the ability of a container closure system to maintain a sterile barrier against potential contaminants throughout the product's lifecycle. A failure in CCI can lead to product degradation, contamination, or sterility breaches, which can have serious health and economic consequences. To mitigate these risks, robust CCI testing methods are employed, with deterministic test methods emerging as the preferred approach due to their reliability and precision.

Container Closure Integrity is essential in preventing the ingress of microorganisms, moisture, or gases into sterile products, particularly in the pharmaceutical and medical sectors. As regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) emphasize the importance of CCI testing, manufacturers are increasingly adopting advanced methods to verify package integrity.

CCIT methods can be broadly classified into two categories: probabilistic and deterministic methods. Probabilistic methods, such as dye ingress and microbial ingress tests, are less reliable as they depend on operator technique and can be highly variable. Deterministic methods, on the other hand, are based on physics and provide more accurate, reproducible, and quantitative results.

Understanding Deterministic CCI Test Methods

Deterministic CCI test methods are designed to detect and quantify defects in packaging with a high degree of precision. These methods are non-destructive, highly sensitive, and capable of providing exact measurements for defects down to the sub-micron level. Unlike probabilistic methods, deterministic tests are not subject to operator variability and environmental conditions, making them ideal for ensuring reliable, repeatable results.

The following key principles differentiate deterministic test methods from probabilistic ones:

• Quantitative Data: Deterministic tests offer numerical data regarding the size and location of defects, which allows for better decision-making.
• Non-destructive Testing: Many deterministic methods allow testing without damaging the product or packaging.
• High Sensitivity: These methods can detect microleaks that may be missed by traditional probabilistic techniques.
• Repeatability: Consistency in results makes deterministic methods the preferred choice for regulatory compliance.

CCI Test Methods Offered by PTI

1. Vacuum Decay Technology

Vacuum decay testing is widely regarded as one of the most effective and precise vacuum-based methods for detecting leaks in packaging. This method offers quantitative measurements that are consistent, reliable, and accurate, along with clear pass/fail criteria.

PTI’s VeriPac series played a pivotal role in the development of the ASTM F2338 standard for vacuum decay leak testing. Recognized within the United States Pharmacopeia (USP) Chapter on Container Closure Integrity (CCI) and compliant with ISO 11607 guidelines, VeriPac technology utilizes absolute or differential pressure transducers to conduct non-destructive testing, enabling the identification of leaks and microscopic defects that might compromise package integrity.

2. MicroCurrent HVLD Technology

Deterministic CCI test methods, such as Vacuum Decay, Microcurrent HVLD, and Helium Leak Detection, represent the gold standard in package integrity testing. Their high sensitivity, repeatability, and quantitative nature make them indispensable tools for ensuring product safety and regulatory compliance. PTI offers a comprehensive suite of deterministic test methods, enabling manufacturers to confidently validate the integrity of their container closure systems across a wide range of applications.

As the regulatory landscape continues to evolve and product safety becomes an increasing priority, the role of deterministic methods in CCI testing will only grow in importance. By employing these advanced testing technologies, manufacturers can mitigate the risk of contamination, ensure product efficacy, and safeguard patient health.

3. Helium Leak Detection

Helium leak testing is a highly sensitive technique employed in container closure integrity testing (CCIT) to evaluate the seal integrity of closed systems by detecting micro-leaks. Leveraging helium’s small atomic radius and inert characteristics, this method uses helium as a tracer gas to identify extremely small breaches within the packaging

The testing process involves introducing helium into the container and subsequently applying a vacuum to generate a significant pressure differential. This pressure gradient causes helium, if there is any defect, to migrate from the container through potential leak paths. The escaping helium is then detected by a helium mass spectrometer, which measures the helium flow rate, commonly recorded as the leak rate, providing quantitative data on the package’s closure performance and integrity.

Deterministic CCI test methods, like Vacuum Decay and Helium Leak Detection, offer unmatched precision and reliability, ensuring product integrity and compliance. As regulatory standards rise, these advanced methods are crucial for safeguarding patient safety and product quality.

In the dynamic landscape of the pharmaceutical industry, advancements in medical science intersect with stringent regulatory standards, underscoring the critical importance of ensuring the integrity of container closures for radioactive pharmaceuticals. This niche sector plays a pivotal role in the diagnosis and treatment of cancer, impacting over 5% of the U.S. population. As the demand for these life-saving products grows, so does the need for effective Container Closure Integrity Testing (CCIT) methods that guarantee safety and efficacy.

What Are Radioactive Pharmaceuticals?

Radioactive pharmaceuticals, often referred to as radiopharmaceuticals, are a specialized category of drugs that contain radioactive isotopes. These products are utilized for diagnostic imaging and therapeutic applications in nuclear medicine, enabling healthcare providers to visualize and treat diseases such as cancer. Given their unique properties and the potential risks associated with radiation exposure, ensuring their packaging integrity is essential to safeguarding both patient safety and operator health.

Packaging Challenges Associated with Radioactive Pharmaceuticals

The packaging of radioactive pharmaceuticals presents unique challenges compared to conventional pharmaceuticals. The need for leak-proof containers is paramount to prevent contamination and ensure the safe handling of radioactive materials. Additionally, packaging must comply with rigorous regulatory standards while maintaining sterility and preventing exposure to radiation. Striking a balance between robust protection and ease of access for healthcare providers is crucial.

Key Challenges Include:

• Leak Prevention: Ensuring that radioactive materials do not escape their containers is critical for both safety and regulatory compliance.
• Radiation Exposure: Packaging must mitigate the risk of radiation exposure to operators and patients during handling and administration.
• Regulatory Compliance: Adhering to stringent regulations while maintaining product integrity adds complexity to the packaging process.

Techniques to Ensure Package Integrity

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity test (CCIT) method, widely used to detect leaks in package seals. It is recognized as the most sensitive and practical vacuum-based leak detection technique, capable of identifying leaks in sealed packaging—whether rigid, semi-rigid, or flexible, and made from porous or non-porous materials. This technology delivers reliable, accurate, and repeatable results, ensuring deterministic package integrity testing. As a non-destructive alternative to traditional methods such as Water Bath and Dye Ingress tests, Vacuum Decay is a valuable solution for leak detection in the pharmaceutical and medical device industries.

How does Vacuum Decay technology work?

Vacuum Decay operates on the fundamental physical principles of container integrity. The process begins by placing the package inside a vacuum chamber, which is tightly sealed and connected to an external vacuum source. Depending on the type of packaging and the sensitivity required, a specific vacuum level is applied. The system then evaluates the test chamber and any dead space for a designated time period. Sensitive differential pressure transducers monitor changes in the vacuum level over time. If the pressure rises beyond a pre-set pass/fail threshold, it indicates a leak in the container.

Benefits of Vacuum Decay technology

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods
• Effective in detecting even minute leaks

2. MicroCurrent HVLD Technology

PTI’s MicroCurrent HVLD technology is a patent-pending, innovative advancement in container closure integrity (CCI) testing, offering a significant improvement over traditional high voltage leak detection methods. This non-invasive, deterministic CCI method is effective across a wide range of parenteral and biologic products, including low-conductivity liquids such as sterile water for injection. The MicroCurrent HVLD test is highly efficient at detecting pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and other defects in packaging formats like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches.

One of the standout features of MicroCurrent HVLD is its use of approximately 50% less voltage, minimizing the exposure of both the product and the environment to less than 5% of the voltage used in traditional HVLD methods. PTI’s E-scan HVLD series represents a top-tier solution for robust container closure integrity testing.

Benefits of MicroCurrent HVLD Technology

• Non-destructive & requires no sample preparation
• Deterministic & non-invasive
• Offline and 100% online inspection at high production speeds
• Highly effective across all parenteral products
• Simplifies the inspection and validation process
• Referenced in Chapter USP 1207 Guidance for CCIT

Sterile packaging is a critical component in the administration of nebulizer drugs, especially given the vulnerability of respiratory medications to contamination. Nebulizers deliver medication directly to the lungs, requiring high levels of sterility to protect patients from the risks of microbial and particulate matter contamination. Any breach in package integrity can jeopardize the safety and efficacy of the drug, leading to potential health risks.

To ensure that the nebulizer medications remain sterile, rigorous package integrity testing is essential. Regulatory bodies like the FDA, USP, and EU have laid down guidelines, including FDA’s Container and Closure System Integrity Testing in Lieu of Sterility Testing (USP 1207) and EU Annex 1, to ensure that high-risk packaging like nebulizer cups and nebules meet the highest standards of sterility.

What are Nebulizers?

Nebulizers are medical devices used to deliver medication in the form of a mist that patients can inhale directly into their lungs. These devices are commonly used to treat respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis.

The effectiveness of nebulizer treatment hinges on maintaining the sterility and safety of the drug until it reaches the patient. Nebulizer medications are usually packaged in pre-filled nebulizer cups, syringes, or blow-fill-seal (BFS) packaging, often referred to as nebules. These packages must remain hermetically sealed to prevent contamination from external environments.

Package Integrity Testing of Nebulizers

Ensuring the integrity of nebulizer packaging is a complex process due to the unique characteristics of the packaging material and design. BFS packaging, one of the most common formats for nebulizer drugs, is prone to leaks in the seams and tear-off regions. Such vulnerabilities can allow gas, debris, or microbes to enter the packaging, compromising the sterility of the drug. On the other hand, egress of the medication from the packaging can occur if the integrity is compromised, leading to under-dosing or exposure to air.

To address these challenges, Container Closure Integrity Testing (CCIT) methods are employed to verify the sterility and stability of nebulizer packaging throughout its lifecycle. Traditional testing methods include visual inspection, dye ingress testing, and microbial challenge testing, but these methods often lack the sensitivity and efficiency needed for today’s complex packaging.

Package Integrity Testing Using Vacuum Decay Technology

Vacuum decay testing is a highly efficient and extensively validated method for Container Closure Integrity Testing (CCIT), recognized for its practicality and sensitivity in detecting leaks in vacuum-sealed containers. Based on fundamental physical principles, this method evaluates container integrity by providing reliable and precise quantitative results, classifying them as either pass or fail. It offers a non-destructive alternative to traditional approaches such as the blue dye test.

PTI's VeriPac system provides a non-invasive solution to conventional leak testing methods like water bath, bubble leak, and blue dye tests. VeriPac systems are specifically designed for testing the integrity of Tyvek and porous packaging, ensuring compliance with both regulatory standards and patient safety requirements. The VeriPac vacuum decay technology, codified as ASTM Test Method F2338 since its inception in 2003, was initially developed for testing Tyvek-lidded trays using PTI’s VeriPac instruments.

The technology operates by connecting VeriPac leak testers to a specially designed test chamber that houses the package sample. A vacuum is applied to the package inside the chamber, and the vacuum level, along with its variation over a predetermined test duration, is monitored using single or dual vacuum transducer technology. Changes in absolute or differential vacuum levels are analyzed to identify the presence of leaks or defects within the package.

Key Benefits of Vacuum Decay technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method
• FDA Recognized Consensus Standard
• Allows for increased sampling
• Quantitative results
• Repeatable
• Rapid test time
• Eliminates cost and waste of destructive testing
• Test results can be easily validated
• SPC laboratory testing or online applications

In the fast-paced world of industrial manufacturing, ensuring the quality and reliability of components is crucial for maintaining the safety and efficiency of operations. Among these components, Chevron seals, play a pivotal role in preventing leaks and maintaining the integrity of various mechanical systems. However, the challenges associated with inspecting these seals for quality and integrity are significant. Non-destructive testing methods, particularly Seal Scan Airborne Ultrasound Technology, offer a powerful solution for overcoming package integrity testing challenges, enabling precise and reliable inspection without compromising the seals' functionality.

Chevron Seal Quality Inspection Challenges

Traditional methods of inspecting chevron seals often involve destructive testing, such as cutting the seal open for visual inspection. This approach is time-consuming, wasteful, and provides limited information about the seal's overall integrity. Additionally, it doesn't allow for real-time quality control during the manufacturing process.

Other challenges in chevron seal quality inspection include:

• Detecting internal defects such as voids, inclusions, and delaminations.
• Assessing the seal's dimensional accuracy and conformity to specifications.
• Evaluating the seal material's properties and homogeneity.
• Ensuring the seal's ability to withstand operating conditions.

Seal Integrity Testing Using Seal Scan Technology

PTI's Seal-Scan® is an advanced non-destructive inspection system employing Airborne Ultrasonic (ABUS) technology to evaluate pouch seals offline. This semi-automatic system, featuring an x-y drive, is engineered for precise detection of seal defects, seal characterization, and material analysis. Utilizing the ASTM F3004 standard, Seal-Scan® provides deterministic, quantitative, and high-resolution assessments of seal quality and integrity. The testing process is non-invasive, requires no sample preparation, and delivers consistent results. Seal-Scan® also integrates sophisticated digital imaging software for comprehensive process control, facilitating detailed seal quality inspection . PTI offers multiple Seal-Scan® configurations tailored to accommodate various package specifications, testing sensitivities, and handling requirements.

Technology overview

Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results
• Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
• Produces high resolution Opto-Acoustic image of seal
• Characterizes overall quality and uniformity of the seal

In the medical field, patient safety is paramount, and ensuring the sterility of surgical tools is a critical part of this safety. Suture packs as well as other surgical instruments, must be maintained in a sterile condition to prevent infections and other complications during surgery. To achieve this, rigorous package integrity testing is required to confirm that suture packs remain sealed and uncontaminated until the moment they are used.

Suture packs are pre-packaged sets containing surgical sutures and occasionally other related instruments. These packs are sterilized and sealed to ensure that they remain uncontaminated until they are opened for use in surgical procedures. Sutures are crucial for closing wounds and surgical incisions, so maintaining their sterility is essential to prevent infections, promote healing, and reduce the risk of complications.

Applications of Suture Packs

Suture packs are used in a wide range of surgical procedures across various medical disciplines, including:

• General Surgery: For closing wounds and surgical incisions.
• Orthopedic Surgery: To repair torn ligaments and tissues.
• Cardiovascular Surgery: For stitching blood vessels and tissues.
• Emergency Medicine: For stitching wounds in trauma cases.

In each of these applications, the integrity of the suture pack is crucial for maintaining sterility and ensuring that the patient receives the highest standard of care.

CCI Testing of Suture Packs

The integrity of suture packs must be thoroughly tested to ensure they have not been compromised during manufacturing, shipping, or storage. Any breach in the packaging seal could lead to contamination, rendering the sutures unsafe for use. Traditional methods of container closure integrity testing(CCIT) include dye ingress testing and bubble emission testing. However, these methods can be limited in sensitivity, are highly subjective and may not detect all potential leaks, particularly those that are very small or in hard-to-detect areas.

CCI Testing using VeriPac 410

The VeriPac 410 is an advanced inspection system that utilizes force decay technology for non-destructive leak detection in blister packs, sachets, and pouches with limited headspace. This system builds on PTI’s vacuum decay technology, adding a force-based measurement component to improve detection accuracy. The force decay technology measures the force resulting from the deflection of a package’s surface during a standard vacuum test cycle. This measurement allows the VeriPac 410 to accurately identify defective packages, even in those with minimal headspace.

Technology Overview

The VeriPac 410 benchtop inspection system operates with a drawer-style test chamber that is specifically designed for the purpose. The system uses a custom package insert that adapts to the shape of the package, enhancing test sensitivity. The vacuum levels are continuously monitored throughout the test cycle, following the ASTM F2338 Vacuum Decay Leak Test Method. A drop in the vacuum level indicates that air is leaking from the package into the test chamber. After the vacuum phase, a pressure plate maps the surface pressure of the package’s lidding. The system detects defects by recognizing deviations in the pressure pattern, thus pinpointing the location of the defect within the package or cavity. VeriPac 410 technology can be scaled for fully automated inspection on the production line.

Benefits of Force Decay leak testing

• Non-destructive, non-subjective, no sample preparation
• Multiple packages can be tested in a single test cycle
• Great choice for in-process testing
• The test is operator independent and can be performed with minimal training
• The test protocol is programmed into the testing unit, hence force decay tests are repeatable

In today's healthcare and pharmaceutical industries, ensuring the integrity of packaging is paramount. This is especially true for sterile products, where the failure of packaging can lead to contamination, posing serious risks to patient safety. Among the various packaging materials available, Tyvek has emerged as a popular choice due to its durability, breathability, and microbial barrier properties.

Tyvek, a synthetic material made from high-density polyethylene fibers, is widely recognized for its exceptional properties, making it a top choice for medical and pharmaceutical packaging. It combines outstanding durability, tear resistance, and breathability with superior microbial barrier protection. These qualities make Tyvek ideal for use in sterile barrier systems, medical device packaging, and pharmaceutical packaging. However, to ensure the highest levels of safety and quality, thorough integrity testing of Tyvek packages is essential.

Why is Tyvek Package Integrity Testing Important?

Ensuring the integrity of Tyvek packaging is crucial for several reasons:

• Patient Safety: Compromised packaging can lead to contamination of sterile products, posing significant health risks to patients. Integrity testing ensures that the packaging remains intact, maintaining sterility until the point of use.
• Regulatory Compliance: Regulatory bodies, such as the FDA and ISO, have stringent requirements for packaging integrity. Adhering to these regulations is essential for market approval and maintaining the reputation of the manufacturer.
• Product Quality: Integrity testing helps in detecting defects, such as pinholes, leaks, and weak seals, which can compromise the quality of the packaged product. Ensuring robust packaging helps in preserving the efficacy and shelf life of the product.
• Cost Efficiency: Identifying and rectifying packaging defects early in the production process can save significant costs associated with product recalls, rework, and liability claims.

Tyvek Package Integrity Testing Using PTI's VeriPac Series

Vacuum decay is a highly efficient and extensively validated Container Closure Integrity testing (CCIT) method, recognized as the most practical and sensitive technique for detecting leaks in vacuum-sealed containers. This method operates on the simple physical principles to evaluate container integrity, providing dependable and precise quantitative results, categorized as either pass or fail. It has become a non-destructive alternative to conventional methods such as the blue dye test.

PTI's VeriPac package integrity testing method offers a non-destructive alternative to traditional water bath leak tests, bubble leak tests, and blue dye leak tests. VeriPac leak test systems are suitable for package integrity testing of Tyvek and porous packaging, ensuring the product meets both regulatory and patient expectations. The VeriPac vacuum decay technology, an ASTM Test Method F2338 was first established in 2003, and was initially based on tests of Tyvek-lidded trays using PTI’s VeriPac instruments.

This technology functions by connecting VeriPac leak testers to a test chamber specifically designed to accommodate the sample package. Vacuum is applied to the package within the test chamber. The level of vacuum and the change in vacuum over a predetermined test period are monitored using single or dual vacuum transducer technology. Variations in absolute and differential vacuum are analyzed to detect the presence of leaks and defects within the package.

Benefits of VeriPac Inspection System:

• Non-destructive test method that ensures quantitative test results
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process

The safety and efficacy of injectable medications rely heavily on the integrity of their packaging. Container closure integrity testing (CCIT) ensures that vials, syringes, and other containers can effectively shield the drug product from contamination and maintain its sterility throughout its shelf life.

What is USP <382>?

Unlike its predecessor, USP, which focused on individual testing of elastomeric materials, USP <382> adopts a holistic approach. It emphasizes testing the functionality of the entire packaging system, including the elastomeric components (closures, stoppers, plungers) integrated with the container (syringe, vial, cartridge). This ensures the elastomeric components perform as intended within the specific packaging system they're designed for.

Published in December 2020, USP introduces a new set of requirements for assessing the functionality of elastomeric closures, stoppers, and plungers used in injectable drug delivery systems. These closures play a critical role:

• Protection: They safeguard the drug product from external contaminants like microbes and moisture.
• Containment: They prevent leakage of the medication during storage and transportation.
• Safe Access: They enable controlled delivery of the drug through needles or spikes without compromising sterility

USP supersedes the functionality testing portion of the previous standard, USP. This new standard places greater emphasis on ensuring that elastomeric components function as intended throughout the lifecycle of the drug product. The compliance deadline of December 1st, 2025, marks a crucial milestone, compelling pharmaceutical companies to recalibrate their practices concerning Container Closure Integrity Testing

Package integrity testing is a crucial step in the development and manufacturing of injectable drugs. These tests evaluate the ability of the packaging system to maintain a sterile barrier and prevent product contamination. USP outlines specific testing methodologies for various aspects of elastomeric component functionality, including:

• Fragmentation: This test assesses the closure's tendency to break into small particles during needle penetration, which could contaminate the drug product.
• Penetration Force: It measures the amount of force required to pierce the closure with a needle or spike, ensuring ease of access for medication administration while safeguarding against accidental punctures.
• Self-Sealing Capacity: This test evaluates the closure's ability to reseal itself after a needle or spike is withdrawn, preventing leakage and maintaining sterility.

Advanced Technologies for Enhanced Package Integrity

Manufacturers are constantly innovating and adopting advanced technologies to ensure robust CCI and meet the demands of USP. These advancements include:

• Non-destructive testing methods: Techniques like ultrasonic testing and laser-based analysis allow for evaluation of closure integrity without damaging the packaging system.
• Material science advancements: Development of new elastomeric materials with improved strength, elasticity, and resealing properties enhances the functionality of closures.
• In-line monitoring systems: Integrating real-time monitoring during the manufacturing process helps identify potential defects and ensure consistent quality of elastomeric components.

The implementation of USP signifies a significant step forward in ensuring the safety and efficacy of injectable medications. By establishing stricter guidelines for CCI testing of elastomeric components, this standard fosters the development of robust and reliable packaging systems for parenteral drug delivery. Continuous advancements in testing methodologies and materials science will further strengthen container closure integrity and contribute to the delivery of high-quality injectable medications.

In today's health-conscious world, nutraceuticals – products that bridge the gap between food and pharmaceuticals – are experiencing a surge in popularity. But ensuring the safety, efficacy, and quality of these products extends beyond the formulation itself. Proper packaging plays a crucial role in protecting these sensitive nutraceuticals from contamination, degradation, and environmental factors throughout their shelf life.

Understanding Nutraceutical Products and their Packaging

Nutraceuticals encompass a wide range of products, including vitamins, minerals, dietary supplements, herbal remedies, and functional foods. These products often contain potent ingredients susceptible to moisture, oxygen, light, and temperature fluctuations. The packaging needs to be carefully selected to create a barrier against these external threats, ensuring the product maintains its potency and quality from production to consumption. Common nutraceutical packaging formats include bottles, capsules, blisters, pouches, and stick packs.

Why is Nutraceutical CCI Testing Important?

Maintaining container closure integrity is paramount for several reasons:

• Consumer Safety: Leaky or compromised packaging can allow harmful contaminants like bacteria, mold, or moisture to enter the product, posing a health risk to consumers.
• Product Efficacy: Exposure to oxygen, light, or moisture can degrade the active ingredients in nutraceuticals, rendering them less effective.
• Shelf Life: Compromised packaging can shorten the shelf life of a product, leading to wasted inventory and financial losses for manufacturers.
• Brand Reputation: Leaky or damaged packaging can negatively impact brand image and consumer trust.

Container Closure Integrity Testing Using VeriPac Series

PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing . These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

The VeriPac SPX offers a robust container closure integrity test (CCIT) solution for nutraceutical package inspection by leveraging Statistical Process Control (SPC). This system enables automated testing to significantly increase sampling rates, ensuring comprehensive quality assurance. Its design allows for seamless technology integration as an add-on to existing production lines, facilitating easy adoption. By improving process and quality control, the VeriPac SPX helps identify defects and early deviations promptly, thereby enhancing overall product integrity and reliability.

Technology Overview

PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute transducer technology is used to monitor the test chamber for both, the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or inline testing.

Benefits of VeriPac Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• Referenced in USP 1207 guidance

The pharmaceutical and medical device industries are witnessing a surge in the development and use of combination products. These products integrate a drug, biologic, or medical device into a single entity, offering improved patient convenience and therapeutic efficacy. However, ensuring the safety and efficacy of these products requires robust Container Closure Integrity testing (CCIT) strategies. This blog delves into the world of combination products, explores the challenges associated with their CCI testing, and introduces MicroCurrent High Voltage Leak Detection (HVLD) technology as a reliable solution.

The rise of combination products is driven by several factors:

• Enhanced treatment options: Combining drugs and devices allows for targeted delivery and improved therapeutic effects.
• Patient convenience: Pre-filled syringes, auto-injectors, and inhalers offer user-friendly administration methods.
• Reduced healthcare costs: Combination products can streamline treatment processes and potentially lower overall costs.

However, ensuring the integrity of the packaging in combination products presents unique challenges:

• Complex design: Integration of different components can introduce potential leak paths.
• Material compatibility: The packaging materials need to be compatible with both the drug and the device.
• Stringent regulations: Regulatory bodies require robust evidence of package integrity throughout the product lifecycle.

Container Closure Integrity Testing of Combination products using MicroCurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a non-destructive and non-invasive Container Closure Integrity Test (CCIT) method that leverages unique voltage characteristics to inspect a wide variety of parenteral products, including complex combination products. This technology is applicable to pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. The MicroCurrent HVLD test method can accurately detect the presence and location of defects such as pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and many others.

To ensure Container Closure Integrity, the method scans a non-conductive sealed container using electrode probes. Any defects in the package will cause a resistance differential and alter the current flow within the container. Unlike traditional HVLD technologies, MicroCurrent HVLD uses approximately 50% less voltage and exposes the product and environment to less than 5% of this reduced voltage. This lower exposure voltage not only minimizes the risk to the product but also significantly reduces ozone production during operation. As one of the most sensitive CCI technologies available, it is particularly suited for high-risk combination products.

Benefits Of Microcurrent HVLD Technology

• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids
• Low voltage exposure to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package integrity testing .
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process
• Offline and automated online inspection

Ensuring the integrity of pharmaceutical packaging is a critical aspect of regulatory compliance. Container Closure Integrity Testing (CCIT) plays a pivotal role in safeguarding product quality and patient safety. Proper training in CCIT is essential for pharmaceutical professionals to meet stringent regulatory requirements and maintain high standards in product integrity. It provides the necessary knowledge and skills to perform accurate and reliable tests, ensuring that packaging maintains its integrity throughout its lifecycle. With increasing regulatory scrutiny, understanding the nuances of CCIT is crucial for compliance with global standards such as USP 1207, Annex 1, ASTM, and ISO.

Significance of CCIT Training

Understanding and adhering to CCIT regulations is crucial for several reasons. It ensures the:

• Safety and efficacy of pharmaceutical products: Proper CCIT procedures safeguard the integrity of containers, preventing product contamination and ensuring the delivery of sterile and potent medication.
• Validity of test results: Skilled operators conducting CCIT tests following regulatory guidelines produce reliable data that upholds product quality and safety.
• Reduced risk of regulatory non-compliance: Trained personnel are better equipped to identify and address potential compliance issues, mitigating the risk of regulatory sanctions.

CCIT Training Services offered by PTI

PTI offers a comprehensive suite of CCIT training programs designed to cater to diverse needs and experience levels. Let's delve into each service:

Regulatory Requirement Training

This training focuses on the regulatory requirements pertinent to CCIT. It helps professionals navigate through complex regulations and standards such as USP 1207, Annex 1, ASTM, and ISO. Understanding these regulations is fundamental to ensuring that CCIT processes comply with legal and quality standards, reducing the risk of non-compliance.

Hands-on System Training

PTI offers hands-on training for all operator levels, from beginners to advanced users. This practical training allows participants to work directly with CCIT systems, gaining experience in setting up, operating, and troubleshooting equipment. Hands-on training ensures that operators are proficient in using the systems, leading to more accurate and reliable test results.

Test Recipe Training

Developing and optimizing test recipes is critical for different applications. PTI’s Test Recipe Training helps professionals create and fine-tune test parameters to suit specific packaging requirements. This training ensures that the tests are not only effective but also efficient, saving time and resources while maintaining high standards of accuracy.

Application Specific Training

Every package or container presents unique challenges in terms of package integrity testing. PTI’s Application Specific Training provides tailored solutions to address these challenges. By reviewing the specific issues associated with a particular package or container, PTI helps professionals find the optimal testing solution, enhancing the reliability of CCIT results.

Life-saving Pharmaceutical products, medications, particularly those in the realm of high-risk biologics and complex drug delivery systems, often require stringent storage and transportation conditions. This critical journey, known as the cold chain, ensures these temperature-sensitive drugs reach patients with their potency and sterility intact.

Maintaining a consistent cold environment throughout the supply chain is undeniably crucial. However, temperature control alone isn't enough to guarantee a drug's efficacy. Even the most minute breach in a container's integrity can have catastrophic consequences. Moisture ingress or exposure to external contaminants can compromise the sterility of the drug, rendering it ineffective or even hazardous to patients. Container closure integrity testing is crucial for this class of pharmaceuticals.

Container Closure Integrity Testing using Helium Leak Detection

Helium leak detection technology has revolutionized container closure integrity testing (CCIT) by providing highly sensitive and precise detection of leaks. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, vials, cold form blister packs, foil pouches and many other package formats. This technology can precisely determine integrity between specific primary container closure system components, making it an ideal choice for testing the integrity of pharmaceutical products.

This method utilizes helium gas, which has exceptional properties that make it an ideal tracer for leak detection purposes. By harnessing the unique characteristics of helium, manufacturers can perform comprehensive testing to identify even the smallest leaks, enhancing the overall integrity of vial packaging.

The LT150 and LT80 cold chain helium mass spectrometers can test containers correctly in cold chain and cryogenic conditions and create 21-CFR Part 11-compliant reports in real-time for helium testing. The proprietary algorithm that supports these systems provide data on flow rate, gas concentration, and other variables. This helps developers in determining the exact size of a leak, down to less than 6 x 10-6-millibars-liters per second helium leak rate, which has become the industry standard for maintaining a sterile barrier.

Technology Overview

The test starts by introducing helium into the package, which is then subjected to a vacuum. The quantity of helium that escapes from the package is then measured using a helium leak detector, providing a quantitative measure known as the leak rate. In addition to leak testing, helium leak detection technology has proven to be effective for tasks such as package design, failure analysis, tooling qualification, packaging line setup and validation, and monitoring product quality. The use of helium leak detection in accordance with ASTM F2391 and USP 1207 is a widely accepted and extensively utilized method in the pharmaceutical industry.

Benefits of Helium Leak Detection

• Leaks can be measured and identified with a high degree of sensitivity.
• Because of the inert properties of the helium, no effect on the materials under test.
• Dry and temperature-independent testing procedure.
• Reduces the cost and overall processing time, since helium leak testing has a faster cycle time
• With a high-speed vacuum approach, the leak test limit can be set to 1 x 10-10 mbar L/sec, allowing for unique comparisons across components, materials, formats, and manufacturing characteristics.

 

In today's world, product quality and safety are paramount. This holds especially true for the packaging industry, where ensuring the integrity of a package is crucial for protecting the product within. Package integrity testing plays a vital role in safeguarding product quality and preventing contamination throughout the supply chain.

Package integrity testing encompasses a variety of methods used to assess the ability of a package to withstand the rigors of the supply chain and protect its contents. These tests evaluate factors like strength, seal integrity, and resistance to external elements like moisture, oxygen, and physical impact. Package leaks can compromise product sterility, potency, and overall quality, leading to recalls and potentially harming consumers.

Why is Automated Package Leak Detection Gaining Importance?

Traditional, manual package integrity testing methods often involve destructive testing or rely on statistical sampling. These methods can be time-consuming, labor-intensive, and may not provide a complete picture of package quality across an entire production run.

Automated leak detection systems address these limitations. They offer several advantages:

• Automated In-Line Testing: VeriPac LPX enables real-time, in-line leak detection for every single package, ensuring comprehensive quality control.
• Increased Efficiency: Automation streamlines the testing process, significantly reducing labor costs and production downtime.
• Enhanced Accuracy: VeriPac LPX utilizes standardized testing methods, minimizing human error and ensuring consistent, reliable results.
• Improved Data Tracking: Automated systems can integrate with production line controls, facilitating data collection and analysis for better quality control practices.

Automated Package Leak Detection using VeriPac LPX

The VeriPac LPX series comprises fully automated systems for inspecting package quality, offering 100% inline testing. The LPX enhances automated testing, ensuring a high level of confidence in packaging line performance. It's a dependable solution for issues related to infrequent testing and addressing process-related quality concerns.

When it comes to Container Closure Integrity testing (CCIT ), sensitivity and reliability are crucial. The VeriPac LPX 430.8S represents the latest generation in automated inspection systems for testing the integrity of parenteral product containers. It offers automated testing for 100% of batches or batch release, featuring an eight-station dual chamber design with a robotic testing platform suitable for various products, including pre-filled syringes, vials, lyophilized products, small molecule liquids, and Water for Injection (WFI).

The VeriPac LPX boasts a dynamic robotic design tailored to diverse production requirements. It's scalable and modular, ensuring it can meet the demands of different production lines. This adaptable platform facilitates reliable automated handling of various packaging formats, from flexible to rigid containers, and parenteral products. Moreover, the VeriPac LPX allows for easy changeover to test different package sizes on the same system.

Benefits of VeriPac Flex

• Deterministic, quantitative test method
• Non-destructive, non-subjective, no sample preparation
• Test multiple packages in a single test cycle
• Cost effective with rapid return on investment
• Supports sustainable packaging and zero waste initiatives
• Simplifies the inspection and validation process
• Accurate and repeatable results
• ASTM test method and FDA standard
• USP < 1207> compliant

Quality assurance is a critical aspect of any manufacturing process, especially in industries like pharmaceuticals and nutrition where consumer safety and product efficacy are paramount. Dry filled pouches are a common packaging solution utilized in these industries to deliver various types of products efficiently and conveniently. Ensuring the quality of these pouches is essential to maintain product integrity and meet regulatory standards.

What are Dry Filled Pouches?

Dry filled pouches are packaging solutions designed to contain and preserve dry powders, granules, or other solid forms of pharmaceuticals or nutritional products. These pouches are typically made from materials such as plastic films or laminates, which provide barrier properties to protect the contents from moisture, oxygen, light, and other external factors that could compromise their quality. Dry filled pouches come in various shapes and sizes, ranging from single-dose sachets to larger multi-dose packs, catering to different product requirements and consumer preferences.

Why is it Important to Ensure Integrity of Dry-Filled Pouches?

Package integrity testing of dry filled pouches is crucial for several reasons. Firstly, it ensures the protection of pharmaceuticals, nutraceuticals, and food supplements from contamination, moisture ingress, and exposure to light, which could compromise their quality and efficacy. Secondly, it ensures compliance with regulatory standards set by authorities such as the FDA and EMA, thereby avoiding penalties and product recalls. Thirdly, it prioritizes consumer safety by detecting potential hazards like product tampering or adulteration. Additionally, package integrity testing helps maintain shelf-life stability by identifying vulnerabilities that could affect the longevity of the enclosed products. Ultimately, it contributes to safeguarding brand reputation by demonstrating a commitment to quality and customer satisfaction.

Package Integrity Testing using VeriPac Flex

VeriPac FLEX Systems offer a powerful solution for non-destructive leak testing of pouches and other flexible packaging. Utilizing the ASTM F2338 standard (recognized by ISO 11607 and FDA), these systems deliver high sensitivity (10-20 micron defect detection) and reliable PASS/FAIL results with quantitative leak rate data.

VeriPac FLEX boasts unmatched versatility. Multiple configurations cater to diverse package formats and sizes, eliminating the need for changeovers. These streamlines testing for everything from small sachets to large bulk bags. The core technology behind VeriPac FLEX is Vacuum decay leak detection. This Container Closure Integrity Test (CCIT) method offers several advantages over destructive testing methods like water baths or dye tests. It eliminates subjectivity, reduces waste, and provides valuable insights into the packaging process itself. Additionally, Vacuum decay offers a faster return on investment compared to destructive alternatives.

Benefits of VeriPac Flex

• Deterministic, quantitative test method
• Non-destructive, non-subjective, no sample preparation
• Test multiple packages in a single test cycle
• Cost effective with rapid return on investment
• Supports sustainable packaging and zero waste initiatives
• Simplifies the inspection and validation process
• Accurate and repeatable results
• ASTM test method and FDA standard
• USP < 1207> compliant

In the pharmaceutical industry, ensuring the safety and efficacy of medication is paramount. This responsibility extends beyond the drug itself and encompasses the entire delivery system, including the vial packaging. Vials act as critical barriers, protecting sensitive medications from contamination, degradation, and physical damage throughout their journey from manufacturing to administration. Maintaining the integrity of this packaging is essential to guarantee product quality and patient safety.

Applications of Vials in the Pharmaceutical Industry

In the pharmaceutical industry, vials are used for a wide range of products, including:

• Injectable medications (liquids, suspensions, powders)
• Lyophilized drugs (freeze-dried medications)
• Ophthalmic solutions (eye drops)
• Vaccines
• Clinical trial samples

The specific type of vial used will depend on the properties of the medication it contains. For instance, some vials may require light or moisture barrier properties, while others may need to withstand extreme temperatures during transport.

Why is Package Integrity Testing of Vials Important?

• Contamination: A compromised vial can allow contaminants like bacteria or moisture to enter, rendering the medication unsafe for use.
• Product Degradation: Exposure to air, light, or moisture can trigger chemical reactions that degrade the medication, reducing its potency or even creating harmful byproducts.
• Loss of Sterility: In the case of sterile medications, a compromised vial can introduce microorganisms, jeopardizing the product's sterility and potentially causing infections.
• Leakage: Leaking vials can lead to product loss, impacting both financial and safety aspects.

Furthermore, compromised vial integrity can damage a pharmaceutical company's reputation and lead to product recalls. Regular and rigorous package integrity testing is crucial to prevent these issues and ensure patients receive safe and effective medications.

Methods to Inspect Vial Packaging

1. Helium leak testing

Helium leak testing, utilizing helium gas as a tracer, is a method employed to detect and quantify leaks within sealed systems. It serves various purposes such as ensuring Container Closure Integrity, aiding in package design, monitoring product quality, conducting failure analysis, and validating line setups. A Mass Spectrometer Leak Detector (MSLD), commonly known as a helium leak detector, is utilized in this process to identify leaks and determine their size. The test involves connecting the test part to the leak detector and introducing helium gas. If a leak is present, helium escapes from the test part, and the partial pressure is measured and displayed on the meter. This method, recognized by the FDA and referenced in the US Pharmacopeia Chapter <1207>, is a consensus standard for package integrity evaluation.

2. Microcurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a non-destructive, non-invasive method for container closure integrity testing. It's highly effective across various applications, including pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. This technique precisely detects leaks in liquid-filled products, including those with extremely low conductivity like sterile water for injection (WFI) and proteinaceous suspensions. By scanning sealed containers with electrode probes, it identifies leaks by analyzing changes in current flow, pinpointing defects and their approximate locations. Compared to conventional HVLD solutions, MicroCurrent HVLD technology uses approximately 50% less voltage and exposes the product and environment to less than 5% of the voltage, making it one of the most effective container closure integrity technologies for parenteral and biologic products.

3. Vacuum Decay Technology

Vacuum Decay serves as a non-destructive method for Container Closure Integrity Testing CCIT adept at detecting leaks in both rigid and flexible packages with nonporous materials. This straightforward approach relies on fundamental physical principles to assess container integrity. Essentially, the process involves subjecting the package to a vacuum within a test chamber and then monitoring any decline in vacuum levels, indicative of a leak. The standard vacuum decay leak test method (ASTM F2338), developed with PTI's VeriPac instruments, holds FDA recognition as a consensus standard for CCI testing. This method is incorporated into ISO 11607 and cited in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Pre-filled syringes have revolutionized injectable drug delivery in the pharmaceutical industry. Their convenience, accuracy, and pre-sterilized nature make them ideal for biologics, ophthalmic drugs, and other medications requiring precise dosing. However, ensuring the integrity of these pre-filled syringes throughout their shelf life is crucial for patient safety and medication effectiveness. Even the smallest micro leak can compromise sterility, leading to microbial contamination and potential infections. Leakage can also affect the potency and stability of the drug itself.

The Critical Need for Package Integrity Testing

The critical need for package integrity testing cannot be overstated, particularly in the context of pre-filled syringes. Package integrity refers to a container's capability to safeguard its contents from external factors such as contamination and fluctuations in the environment. For pre-filled syringes, maintaining package integrity throughout the product lifecycle is of paramount importance. This ensures the sterility of the medication and prevents interactions with external elements that could potentially alter its potency or stability. Leaks in pre-filled syringes can pose several significant threats:

• Microbial Contamination: Leaks create a pathway for microorganisms to enter the syringe, compromising the sterility of the medication and potentially leading to serious infections for patients.
• Loss of Potency: Leakage can allow air or moisture to enter the syringe, which may degrade the drug product over time, reducing its effectiveness.
• Product Inconsistency: Leaks can lead to variations in the amount of medication delivered, affecting the intended therapeutic effect.

Integrity Testing of Pre-Filled Syringes using Helium Leak Detection

Helium leak testing involves identifying leaks in sealed systems by using helium as a tracer gas and measuring its concentration as it leaks out. This method is highly effective and provides precise leak rate data surpassing other testing methods. It is particularly useful for evaluating the integrity of pharmaceutical and parenteral product packaging. The process begins by filling the package with helium and subjecting it to vacuum. Then, a helium leak detector is used to quantify the amount of helium escaping the package, indicating the leak rate. This technology is valuable for various applications such as package design, failure analysis, tooling qualification, packaging line setup and validation, and product quality monitoring. Helium Leak Detection, as outlined in ASTM F2391, is a widely recognized and utilized method in the pharmaceutical industry.

Why use Helium as a Tracer Gas?

Helium is considered as an ideal choice of tracer gas because of the following reasons:

• Helium is non-toxic, non-condensable, non-flammable.
• It is inert, making it safe for use as it will not interact with the components being tested.
• The atom size of helium is really small, allowing it to breach pathways reliably and easily.
• Compared to other tracer gases, helium is less expensive and readily available.
• Its presence in the atmosphere is not more than ppm.

Incorporating helium leak detection in pre-filled syringe testing enhances patient safety and medication efficacy by swiftly identifying even the smallest leaks, ensuring optimal package integrity throughout the product lifecycle. With its non-toxic, inert nature and high sensitivity, helium emerges as an ideal tracer gas for precise and reliable leak detection, safeguarding the integrity of pharmaceutical products.

Maintaining the container closure integrity of vials stands as a paramount concern within pharmaceutical manufacturing, crucial for upholding product quality, efficacy, and ensuring patient safety. Conventional vial leak testing methodologies possess inherent limitations in detecting microleaks, posing a potential risk to product sterility. In response to this challenge, the advent of MicroCurrent High Voltage Leak Detection (HVLD) technology presents a groundbreaking solution, boasting unparalleled sensitivity and precision in vial leak detection.

Overview of Vial Leak Testing

Vial leak testing constitutes a pivotal stage in pharmaceutical manufacturing, serving to pinpoint any potential breaches in vial integrity that could culminate in contamination or compromise product stability. Established techniques encompass visual inspection, dye ingress and other destructive methods. Nonetheless, these methods may fall short in identifying microleaks, characterized by minute defects capable of facilitating the ingress of contaminants. Hence, manufactures are now moving towards more deterministic technology that offer quantitative and reliable test results.

Vial Leak Testing using MicroCurrent HVLD Technology

MicroCurrent HVLD is a non-destructive method for assessing the integrity of container closures in non-porous pharmaceutical and parenteral products. This technique relies on the principle of electrical current to detect any leaks in a range of liquid-filled products, including those with extremely low conductivity such as sterile water for injection (WFI) and products containing proteins or suspensions.

Compared to conventional HVLD technology, MicroCurrent HVLD significantly reduces product voltage exposure to less than 5%, thereby eliminating any potential risk to the product and reducing Ozone formation during testing.

In this method, the container is scanned using high voltage probes. One side of the container is subjected to high voltage, while a ground probe is attached to the other side. If the container is intact, both sides offer complete electrical resistance, and no significant current passes through. However, if a micro-leak or fracture is present, breakdown resistance occurs, allowing current to flow through the defect.

HVLD is unique among leak detection methods as it does not require mass to pass through the defect site; instead, it transmits electricity through the crack. This sensitivity enables HVLD to detect leaks that other conventional leak test solutions may miss.

Benefits of MicroCurrent HVLD Technology

• Scalable from the R&D Laboratory to production line
• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package integrity testing
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process

In the high-stakes world of pharmaceuticals and medical devices, ensuring the integrity of packages isn't a mere formality; it's a fundamental pillar of safety and efficacy. For decades, meticulous package integrity testing methods have served as the gatekeepers, diligently sniffing out potential breaches that could compromise lives and livelihoods. Yet, traditional approaches often fell short – lacking the sensitivity to detect microscopic flaws, the versatility to handle diverse package formats, and the quantitative data to provide actionable insights. In order to overcome the shortcomings of traditional methods, manufacturers now rely on non-destructive, deterministic package testing alternatives.

Helium Leak Detection - An Overview

Helium leak testing refers to the process of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. It is an effective container closure integrity test method, aimed at evaluating the integrity of pharmaceutical and parenteral products. The process involves filling the package with helium and subjecting it to vacuum. A helium leak detector is then utilized to quantitatively measure the amount of helium escaping from the package, which is expressed as a leak rate. Beyond evaluating container closure integrity, helium leak testing finds applications in product design, quality analysis, failure analysis, and validation. It offers flexibility as it can be conducted with or without a test chamber, enabling testing for "in-leakage" or "out-leakage," as well as locating leaks.

Helium is considered an ideal choice of tracer gas because of multiple reasons. Helium is non-toxic, non-flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is relatively safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes.

Helium Leak Testing Using SIMS 1915

The Seal Integrity Monitoring System (SIMS) 1915+ stands out as the ideal solution for helium-based leak detection across a range of pharmaceutical and medical device packaging systems, including vials, syringes, cartridges, and blister cards. It's particularly effective for parenteral products, such as ensuring the integrity of rubber stoppers on vials or plungers on syringe assemblies.

Utilizing helium as the tracer gas, this system allows for quantitative testing that surpasses traditional methods like vacuum bubble and dye penetration tests by a significant margin. This quantitative approach facilitates direct comparisons among different packaging materials, formats, production line settings, and storage conditions, supporting the entire product lifecycle. The SIMS 1915+ offers the capability for quantitative analysis with a sensitivity level as low as 1 x 10-10 mbar/L/sec. It provides comprehensive data sets instead of simplistic pass/fail criteria and can conduct testing at room temperature.

Each SIMS 1915+ Helium Leak Testing instrument is meticulously crafted to meet client-specific standards and package configurations. We specialize in engineering custom test fixtures tailored to the components being tested, ensuring precision and accuracy to fulfill your study objectives, accommodate various package configurations, and meet quality monitoring requirements.

SIMS 1915+ Options:

• LT 80 and LT 150 Cryo-Chiller Low Temperature Add-on Modules for ultra-cold Container Closure Integrity testing using helium leak methodology.
• Various sizes of Vacuum Test Fixtures to accommodate all package types and sizes
• Custom Test Fixtures to allow Helium leak testing for non-vacuum chamber applications.
• Additional External Helium Leak standards in various leak rate ranges.
• Helium Sniffer probe – for site specific determination of leak sites.

In pharmaceutical packaging, ensuring the integrity of containers is paramount to maintaining product safety and efficacy. Various technologies and methods are employed for package integrity testing, with MicroCurrent High Voltage Leak Detection (HVLD) emerging as a reliable and efficient solution.

MicroCurrent HVLD technology is a non-destructive container closure integrity testing (CCIT) method designed to detect leaks in sealed pharmaceutical containers, such as vials, ampoules, and syringes. Unlike traditional methods like dye ingress testing or visual inspection, which may be destructive or less sensitive, MicroCurrent HVLD offers a high level of sensitivity without compromising the integrity of the package.

The technology operates by applying a high voltage potential across the container and monitoring the resulting electrical current. When a breach or defect is present in the container's seal, the electrical current will deviate from the baseline, indicating the presence of a leak. The sensitivity of MicroCurrent HVLD allows it to detect leaks as small as microns, ensuring that even minute defects are identified.

Role of MicroCurrent HVLD Technology in Pharmaceutical Package Integrity Testing

MicroCurrent HVLD technology plays a crucial role in pharmaceutical package integrity testing by offering enhanced sensitivity, allowing for the detection of even the smallest defects in packaging to mitigate the risk of product contamination or degradation. Its non-destructive testing capability ensures that tested products remain intact, facilitating their seamless progression through the manufacturing process. Additionally, the high throughput nature of MicroCurrent HVLD systems enables efficient testing of large volumes of pharmaceutical containers, making it scalable to meet high production demands. Furthermore, its compliance with regulatory standards ensures adherence to requirements for product quality and safety, while its cost-effectiveness, despite initial investment, leads to long-term economic benefits through the prevention of product loss and reduced need for retesting.

List of E-Scan Technologies offered by PTI

1. E-Scan 605: The E-Scan 605 is an entry-level solution ideal for basic container closure integrity (CCI) testing, providing rapid PASS/FAIL test results. Featuring single-channel operation and manual loading/unloading, it offers a compact footprint suitable for low- to medium-volume testing needs.

2. E-Scan 615: The E-Scan 615 is the ideal instrument for laboratory R&D QC testing and product quality monitoring of parenteral products. Testing takes literally seconds and provides operators with PASS/FAIL and supporting quantitative data

3. E-Scan 655: The E-Scan 655 is intended for in-depth analytical container closure integrity testing of parenteral products. Location defect identification is possible along with quantitative data and PASS/FAIL.

4. E-Scan RTX: Fully automated container closure integrity testing with robotic pick & place hangling. Ideal for automation it the laboratory and production line settings.

In summary, PTI's E-Scan series offers a range of MicroCurrent HVLD solutions catering to diverse pharmaceutical packaging needs, ensuring precise integrity testing while prioritizing efficiency, safety, and compliance with regulatory standards. These advanced technologies represent a pivotal step forward in safeguarding product quality and patient safety within the pharmaceutical industry.

In today's health-conscious world, the popularity of nutraceuticals – those magical molecules promising a healthier you – is exploding. From vitamin gummies to herbal concoctions, these nutritional powerhouses line our shelves, offering a convenient path to wellness. But what about the very container that holds these life-changing potions? Nutraceutical packaging comes with unique challenges and navigating them requires innovative solutions and cutting-edge testing methods.

While nutraceuticals offer a plethora of health benefits, their packaging comes with inherent risks that can compromise product quality and safety. The nutraceutical industry faces unique challenges related to packaging, including ingredient stability, contamination, and regulatory compliance. Exposure to light, moisture, and oxygen can degrade the potency of bioactive compounds, rendering the product less effective. Contamination during the manufacturing and packaging process poses a risk to consumer safety. Additionally, regulatory bodies impose stringent standards to ensure the quality and authenticity of nutraceutical products.

Methods to Ensure Integrity of Nutraceutical Packaging

To address these challenges, manufacturers are turning to advanced testing methods for package integrity. Package integrity testing involves assessing the strength and robustness of the packaging to prevent leaks, breakages, or other vulnerabilities.

1. VeriPac Series

The VeriPac series by PTI offers cutting-edge inspection systems designed for leak detection and package integrity testing. These systems employ a non-destructive and non-invasive approach, contributing to waste reduction while delivering real-time and quantitative results. The technology is based on the ASTM-approved Vacuum Decay leak test method F2338, a methodology recognized by the FDA for its reliability and accuracy.

The VeriPac testers seamlessly connect to specially designed test chambers, creating a controlled environment for the inspection process. During testing, a vacuum is applied to the package, and absolute transducer technology is employed to monitor changes in vacuum levels over a predefined test duration. This meticulous monitoring allows the system to swiftly identify leaks and defects within the package.

One of the key advantages of the VeriPac series lies in its efficiency and objectivity. The entire process is quick, eliminating the need for subjective assessments and ensuring a non-destructive testing approach. This makes the VeriPac series suitable for various testing scenarios, ranging from laboratory offline testing to the rigorous demands of 100% inline testing in production environments.

Given the adherence to the ASTM-approved Vacuum Decay leak test method F2338, these inspection systems not only meet industry standards but also comply with FDA regulations. This recognition further underscores the reliability and precision of the VeriPac series in ensuring the integrity of packages.

2.Seal-Sensor PQX Technology

The Seal-Sensor PQX is an advanced automated pouch seal quality inspection system designed for seamless integration into production lines. Leveraging Seal-SensorTM Airborne Ultrasonic technology, this cutting-edge system conducts swift online scans of final pouch seals, aligning with ASTM Test Method F3004 and FDA consensus standards. Its deterministic and quantitative approach enables the rapid identification of defects, including incomplete seals, weak areas, and concealed issues that could compromise product quality.

The system operates with remarkable efficiency, delivering pass/fail results and generating traceable data in less than a second, even at speeds of up to 350 mm/sec. This ensures a quick and reliable assessment of seal quality, contributing to enhanced overall production efficiency.

The Seal-Sensor PQX is characterized by its user-friendly design and plug-and-play functionality, making it easy to integrate into existing manufacturing setups. Its modest footprint ensures that it can be seamlessly incorporated into various production environments without occupying excessive space. In the event of a defective pouch seal, the system features a built-in reject chute that promptly removes defective pouches from the production line. This not only prevents substandard products from progressing further in the manufacturing process but also helps maintain the integrity of the overall production flow.

As the nutraceutical boom continues, innovative packaging and rigorous testing methods like VeriPac and Seal-Sensor PQX are crucial to ensure the safety, efficacy, and trust in these life-changing supplements. By prioritizing package integrity, we unlock the true potential of these wellness wonders.

Tablets and capsules, the backbone of oral medication, are commonly encapsulated in blister packs. These packs, crafted from thermoformed plastic and sealed with aluminum foil or film, offer a trifecta of advantages: protection, tamper evidence, and convenience. Shielding pharmaceuticals from physical damage, moisture, and light, blister packs ensure dosing accuracy and provide tamper evidence, instilling confidence in consumers. Furthermore, their user-friendly design facilitates easy dispensing and portability of individual doses.

Package integrity testing emerges as a critical component in pharmaceutical quality control. Compromised packaging poses multifaceted risks, including product loss, contamination, and degradation. Leaking or damaged packages can lead to economic setbacks for manufacturers and jeopardize consumer safety. Exposure to external elements such as moisture, light, or oxygen can degrade the quality of medication, compromising its therapeutic efficacy.

OptiPac Technology: Pioneering Non-Destructive Integrity Testing

The OptiPac Leak Detection System is a non-destructive container closure integrity testing method specifically designed for blister packs. Employing One-Touch Technology, OptiPac ensures a swift test cycle without the need for changeovers or sample preparation. This innovative technology enables rapid detection of sub-5-micron defects, contingent on blister cavity volume. Unlike the vacuum-based blue dye test, OptiPac applies controlled inputs and measured outputs, eliminating the complications and reliability issues associated with dye ingress methods.

Technology Overview

OptiPac employs volumetric imaging technology under vacuum, coupled with topographic imaging, to identify the presence and location of leaks. The testing process involves placing the sample on the testing area, initiating a vacuum-based measurement upon pressing the start button. As the blisters expand under vacuum, air is drawn out through any leaks present. In the case of a leak, the air escapes into the chamber, causing a collapsed blister cavity. The dynamic vacuum test sequence captures volumetric images and measurement readings, pinpointing defective blister cavities. The system delivers a clear pass/fail result, along with quantitative measurements for each package test. OptiPac systems by PTI yield definitive results based on accurate and measurable quantitative data, reliably detecting leaks down to 5 microns. The interface is user-friendly, requiring no intricate parameter adjustments for new blister packaging formats, setting it apart from other non-destructive blister package inspection systems.

OptiPac’s insightful technology offers a suite of advanced functions:

• Auto configuration for easy recipe setup and validation of new blister formats
• Auto orientation of blister packs (test blister packs in any position –no specific orientation)
• Auto calibration is an integrated one-touch function
• Advanced batch reporting with audit trail including image of blister pack and defect results

OptiPac Benefits

• Non-destructive technology - Pass/Fail results backed by quantitative test data
• Completely tool-less
• No changeover to test different blister formats
• Identifies defective cavity
• Pre-loaded recipe library with easy recipe setup and validation of new blister formats

Class III medical devices are the highest risk medical devices, as they support or sustain life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III medical devices include:

• Pacemakers
• Defibrillators
• High-frequency ventilators
• Cochlear implants
• Fetal blood sampling monitors
• Implanted prosthetics

Because of the high risk associated with Class III medical devices, it is essential to ensure that their packaging is intact and that the devices are sterile. Class III medical devices are the most strictly regulated medical devices by the US Food and Drug Administration (FDA).

There are several challenges associated with Class III medical device package integrity testing . One challenge is that the devices themselves are often complex and delicate, making them difficult to test without damaging them. Another challenge is that the packaging for Class III medical devices must be very effective in protecting the devices, maintain the sterile barrier and protect from contamination and damage during product lifecycle until point of use. To ensure the integrity of Class III medical devices, it is important to implement a comprehensive quality control program that includes the following measures:

• Design and testing: Medical device manufacturers must design and test their devices to ensure that they meet all applicable safety and performance standards.
• Manufacturing and assembly: Medical device manufacturers must implement strict quality control measures during the manufacturing and assembly process to ensure that devices are produced consistently and to a high standard of quality.
• Packaging: Medical device manufacturers must design and test their packaging to ensure that it can protect the devices from contamination and damage during shipping and handling.
• Testing: Medical device manufacturers must test a sample of each batch of devices to ensure that they meet all applicable safety and performance standards.

Package integrity testing and seal integrity testing are crucial for medical device packages to ensure the protection of the enclosed products from external contaminants and environmental factors. Maintaining package integrity is essential to prevent the compromise of sterile barriers, safeguarding the sterility of medical devices and ensuring their efficacy in clinical applications. Additionally, these tests help meet regulatory requirements, promoting patient safety and ensuring the reliability of medical devices throughout their lifecycle

1. Vacuum Decay technology

PTI's VeriPac Vacuum Decay technology is a non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The VeriPac system uses a vacuum chamber to create a differential pressure between the inside and outside of the packaging. This differential pressure is then used to detect any leaks in the packaging. PTI's VeriPac system is particularly well-suited for testing Class III medical device packaging because it is able to test a wide variety of packaging materials and designs. Additionally, the VeriPac system is able to test the integrity of the packaging without damaging the packaging or the product inside.

2. Airborne Ultrasound technology

PTI's Airborne Ultrasound technology is another non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The Airborne Ultrasound system uses ultrasonic waves to inspect the packaging for any defects. The Airborne Ultrasound system is particularly well-suited for testing Class III medical device packaging because it is able to detect a wide variety of defects, including small holes, tears, and wrinkles. Additionally, the Airborne Ultrasound system is able to test the integrity of the packaging without damaging the packaging or the product inside.

Package integrity testing is an essential part of the quality control process for Class III medical devices. By implementing CCI testing, medical device manufacturers can help to ensure the safety and efficacy of their devices.

In the pharmaceutical industry, the safety and efficacy of products are of utmost importance, and maintaining these qualities throughout the distribution and storage chain is a critical aspect of ensuring public health. One key element in achieving this goal is the rigorous implementation of Container Closure Integrity (CCI) testing.

CCIT refers to the evaluation of the ability of a pharmaceutical package to prevent the ingress of contaminants, as well as the escape of the product, ensuring that the package maintains its integrity over time. This process is essential in safeguarding the quality and safety of pharmaceutical products, as any compromise in the packaging can lead to contamination, degradation, or other adverse effects on the medication.

Traditional Container Closure Integrity (CCI) assessment has heavily relied on destructive testing methods, such as water bath and dye tests. These approaches involve immersing packaging materials in water or applying dyes to identify potential leaks. However, these methods present significant drawbacks. They are time-consuming, requiring substantial resources for testing and result analysis, which is highly subjective and varies from operator to operator. This prolonged process can hamper production efficiency and delay product release.

Moreover, the accuracy of these methods is questionable, as they may not reliably detect all types of leaks. The subjective nature of human interpretation in analyzing results leads to potential inconsistencies and misinterpretations. Additionally, the destructive nature of these tests contributes to product loss and waste, escalating production costs and raising environmental concerns.

In the context of a growing emphasis on sustainable practices, there is a rising demand for alternative, non-destructive, and objective CCI testing approaches that can address these limitations and align with contemporary production and sustainability standards.

CCI Testing using Vacuum decay technology

To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.

Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)

How does Vacuum Decay Technology work?

Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.

Key Benefits of Vacuum Decay Technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method
• FDA Recognized Consensus Standard
• Allows for increased sampling
• Quantitative results
• Eliminates cost and waste of destructive testing
• Test results can be easily validated
• SPC laboratory testing or online applications

In the world of pharmaceuticals, the integrity of vial container closures is a matter of utmost importance. Vials are small, cylindrical containers made of glass or plastic, designed to store a wide range of pharmaceuticals, including vaccines, medications, and other sensitive compounds. Their significance lies in their ability to preserve the integrity and potency of these substances. Vials shield their contents from external factors like air, moisture, and contaminants, ensuring that the product remains uncontaminated and effective.

Package integrity testing of vials is crucial to maintain the high standards of pharmaceutical products. Any breach in the vial's integrity can lead to contamination, rendering the contents ineffective or even harmful. It's not just about preserving the product; it's also about ensuring the safety of the end-users. Therefore, advanced leak testing strategies play a vital role in guaranteeing that vials are sealed securely. Vial leak testing involves identifying leaks or breaches in the vial container closures. The main goal is to confirm that the closure system maintains an airtight seal, preserving the sterility and efficacy of the product. Vial leak testing can be performed using various methods, each with its own advantages and limitations.

1. PTI's MicroCurrent HVLD Technology

PTI's MicroCurrent High Voltage Leak Detection (HVLD) is a Container closure integrity testing method that plays a crucial role in ensuring vial integrity, for liquid fill applications including proteinaceous products and small molecule liquids. It operates on a fundamental principle: detecting breaches by applying high voltage to the vial's container closure. When high voltage is applied, if there is even a minor breach in the seal, the current will pass through the vial, alerting the system to potential defects. This technique is incredibly sensitive and can identify breaches that might otherwise remain undetected by traditional methods.

One key advantage of MicroCurrent HVLD is its non-destructive nature. Unlike destructive testing methods, this technology does not harm the vial or its contents in any way. This unique method utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. Its ability to pinpoint even minute defects in vial closures ensures that products maintain their sterility and efficacy.

2. PTI's VeriPac Vacuum Decay Technology

VeriPac Vacuum Decay Technology is another container closure integrity test (CCIT) used for vial leak testing, for both liquid fill and lyophilized applications. This method relies on creating a controlled environment within which the vial is tested. By introducing vacuum and pressure differentials, VeriPac can identify leaks with remarkable accuracy. If there's a breach in the vial closure, the changes in pressure within the controlled environment will be detected, indicating a potential defect.

One of the standout features of VeriPac is its ability to pinpoint defects with exceptional precision. It can detect leaks in various vial types, whether they are glass or plastic, and offers a versatile solution for pharmaceutical quality control. Like MicroCurrent HVLD, VeriPac is non-destructive, ensuring that the vials and their contents remain unaltered during the testing process. This makes VeriPac a reliable choice for pharmaceutical companies looking to maintain the highest standards of quality and safety in their products.

In the pharmaceutical industry, maintaining vial container closure integrity is paramount. The consequences of compromised vials can be detrimental, affecting not only the product but also the health and safety of the end-users. Advanced leak testing strategies, such as PTI's MicroCurrent HVLD and VeriPac Vacuum Decay technologies, provide innovative solutions to this challenge. By using these cutting-edge methods, manufacturers can ensure the highest standards of quality and safety in their products.

Food packaging is essential for protecting food from contamination, spoilage, and damage. It also plays an important role in maintaining food quality and shelf life. Package integrity is a critical factor in ensuring the safety and quality of food products. Food packaging can be made from a variety of materials, including plastic, metal, glass, and paper. The type of packaging used depends on the type of food being packaged and its intended use. For example, perishable foods, such as meat and dairy products, require packaging that can provide a barrier to moisture and oxygen to prevent spoilage. Non-perishable foods, such as canned goods and dried goods, may require less stringent packaging requirements. Packaging that goes through a processing or retort system presents yet another set of challenges to insure integrity of the package and protection of product quality.

Significance of Food Package Integrity Testing

Package integrity testing is the process of evaluating the ability of a package to protect its contents from contamination and spoilage. It is an important quality control measure that can help to ensure food safety and quality. There are a variety of different package integrity testing methods available. Some methods are destructive, while others are non-destructive. Destructive methods, such as water bath testing, involve damaging the package to test for leaks. Non-destructive methods, such as Vacuum Decay testing, do not damage the package.

Package Integrity Testing using VeriPac Vacuum Decay Technology

The VeriPac technology is a non-destructive Container Closure Integrity Test (CCIT) system that uses Vacuum Decay technology to detect leaks in food packaging. Vacuum decay is an ASTM-approved test method (F2338) that is recognized by the FDA as a consensus standard for package integrity testing.

To test a package using VeriPac technology, the package is placed in a vacuum chamber and the pressure is applied. The system then measures the rate at which the pressure in the chamber changes. If there is a leak in the package, the pressure in the chamber will increase more quickly. Vacuum Decay technology is a highly sensitive and accurate test method that can detect leaks as small as 20 microns. It is also a very versatile test method that can be used to test a wide variety of food packaging types and sizes.

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Defect detection down to 0.2 ccm.
• High level of sensitivity, repeatability and accuracy.
• Short cycle time provides operator with PASS/FAIL result.
• Small footprint and modular portable design.
• ASTM test method and FDA standard.
• Referenced in USP 1207 guidance.

Overall, the VeriPac Vacuum Decay is a valuable tool for food manufacturers and processors who are looking to improve their quality control processes and ensure the safety and quality of their products.

In today's fast-paced world, businesses across various industries are constantly seeking ways to streamline their operations, enhance productivity, and deliver innovative solutions to their customers. To meet these demands, many companies turn to Comprehensive Integrator and Original Equipment Manufacturer (OEM) solutions. These versatile services offer a range of benefits, from reducing development time to ensuring product quality and scalability.

PTI's Integrator and OEM Solutions are designed to help manufacturers automate their package integrity testing processes. PTI offers a variety of sensory technologies, including Airborne Ultrasound, Vacuum Decay, Microcurrent HVLD, and Force Decay, that can be integrated into existing packaging lines or used to create new PIT systems. PTI also works closely with OEMs to integrate its technologies into their equipment.

PTI's Integrator and OEM Solutions offer a number of benefits, including:

• Increased productivity: By automating package integrity testing, manufacturers can free up operators to focus on other tasks, such as production or quality control.
• Improved product quality: Automated package integrity testing can help to identify and remove defective products from the production line, preventing them from reaching customers.
• Reduced costs: It can help to reduce the cost of labor and materials, as well as the risk of recalls.
• Compliance with regulations: PTI's solutions can help to ensure that products meet regulatory requirements for package integrity.

If you are a manufacturer who is looking to automate your package integrity testing process, PTI's Integrator and OEM Solutions can help. PTI has a team of experienced engineers who can help you to select the right sensory technology and integrate them into your production line. PTI also offers a variety of services, such as training and support, to help you get the most out of your PIT system.

Here are some of the specific solutions that PTI offers:

• Airborne ultrasound technology is used to inspect and analyze seals non-destructively. PTI's Seal-Scan® and Seal-Sensor products use airborne ultrasound to provide real-time seal quality inspection on the production line.
• Vacuum decay technology is used to leak test packages and containers. PTI's VeriPac platform uses vacuum decay to provide a deterministic method for leak testing that is repeatable and reliable.
• MicroCurrent HVLD technology is a CCIT test used to inspect packages for defects such as pinholes and cracks. PTI's MicroCurrent HVLD technology is non-destructive and can be used to inspect a variety of package materials.
• Force decay technology is used to measure the force required to open a package. PTI's Force Decay technology can be used to detect counterfeit products or to verify the integrity of packages.

If you are interested in learning more about PTI's Integrator and OEM Solutions, please visit our website or contact us for a consultation.

The integrity and safety of sterile products are critical in the pharmaceutical, biotechnology, and medical device industries. Sterile materials are essential in patient care, surgical procedures, and medical treatments because they are free of live germs. To ensure that these items stay contaminant-free throughout their shelf life and delivery to patients, thorough packaging integrity testing is required.

The sterile product package serves as the first line of defense against potential contaminants, safeguarding the product from environmental hazards, physical damage, and microbial ingress. Any compromise in the packaging can lead to compromised product quality, reduced efficacy, and increased risks to patient health. Therefore, comprehensive package testing is indispensable to validate the barrier properties, durability, and overall performance of the packaging materials.

This blog delves into the significance of sterile product package testing, shedding light on the various testing methods employed and the role they play in maintaining the integrity of sterile products.

Sterile package integrity testing methods:

1. Vacuum Decay technology:

Vacuum Decay technology is a non-destructive container closure integrity test (CCIT) capable of detecting leaks in nonporous, rigid or flexible packages. Vacuum Decay leak testing is conducted by placing a sample package in a well-fitting evacuation chamber, which is provided with an external vacuum source. The vacuum levels as well as the change in vacuum over a fixed test time are closely observed using single or dual vacuum transducer technology. Changes in vacuum level beyond a predetermined pass/fail limit indicate defects within the package. PTI’s VeriPac Vacuum Decay series can non-destructively test packaging down to sub-micron leak rates - making it an excellent alternative to destructive testing methods.

2. Microcurrent HVLD technology:

Microcurrent HVLD is a unique High Voltage Leak Detection technology, highly effective across all liquid filled parenteral products. Its applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defects makes it an ideal choice for testing high risk pharmaceutical and parenteral products.

In conclusion, sterile product package testing is a cornerstone of product quality assurance, safety, and regulatory compliance. By meticulously examining packaging materials, seals, and integrity, manufacturers can safeguard product sterility, extend shelf life, meet regulatory expectations, and instil confidence in their consumers. As industries continue to advance and consumer expectations rise, investing in robust sterile product container closure integrity testing methodologies remains a fundamental necessity for any organization producing and distributing sterile products.

Ensuring the integrity of container closures is a critical aspect of pharmaceutical and biotechnology industries. Maintaining the integrity of containers, such as vials, syringes, and cartridges, is essential to preserve the quality, efficacy, and safety of products throughout their entire lifecycle. Traditionally, blue dye testing has been a widely used method to detect leaks and potential breaches in container closures. However, with the ever-evolving landscape of technology and scientific advancements, it is essential to explore and embrace alternative methods that offer higher sensitivity, reliability, and efficiency.

In this blog, we will explore cutting-edge container closure integrity testing methods that go beyond the limitations of blue dye testing. While blue dye testing has served as a valuable tool for detecting gross leaks, it may not be sufficient to detect micro-leaks or hairline cracks that could lead to potential risks during storage, distribution, and administration of pharmaceutical products.

Non-destructive CCI testing methods offered by PTI:

1. Microcurrent HVLD Technology

High Voltage Leak Detection (HVLD) is a non-destructive and non-invasive container closure integrity test (CCIT) used to assess the closure integrity of parenteral product packaging, such as pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. By employing quantitative electrical conductivity measurements, this technique allows for non-destructive testing of packages.

The HVLD method involves passing micro-current signals through the sample packages. If there is a leak in the package, the electrical resistance of the sample decreases, leading to an increase in current flow. The newer MicroCurrent HVLD technology operates using approximately 50% less voltage and exposes the product and surrounding environment to less than 5% of the voltage compared to traditional HVLD solutions. This makes it a more efficient and safer option for evaluating packaging integrity in pharmaceutical and medical applications.

2. Vacuum Decay technology

Vacuum Decay has proven to be an exceptionally effective technology for detecting leak paths and ensuring the integrity of packages. One of its key advantages is the ability to provide quantitative, deterministic, and reliable test results without causing any damage to the containers being tested. The process involves placing the packages in a meticulously fitted evacuation test chamber connected to an external vacuum source. Throughout the testing, the vacuum levels are constantly monitored to detect any deviations from the predetermined target vacuum level. If a package has defects, air will escape, leading to a noticeable change in the chamber vacuum level. Conversely, non-defective packages will retain the air, ensuring the chamber vacuum level remains constant. The versatility of this method is remarkable as it can accommodate a wide range of packaging formats, including filled and sealed rigid, semi-rigid, and flexible packages made from both non-porous and porous materials.

3. Helium Leak Detection Technology

Helium leak testing is the method of locating leaks in various enclosed or sealed systems by using helium as a "tracer" gas and measuring the concentration of the gas as it escapes due to a leak. Helium is used as a tracer gas because it is non-toxic, non-flammable, and non-condensable, and its atmospheric concentration is less than 5 ppm. Helium, as the second-smallest molecule in the periodic table, can flow through practically any defect or openings. Furthermore, because it does not react with other compounds, helium is relatively safe to use. To find and measure the leak, a mass spectrometer leak detector (MSLD), also known as a helium leak detector, is used.

4. Volumetric Imaging Technology

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection of blister packages. To identify leaks, the OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package integrity testing systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

In conclusion, as the pharmaceutical and biotechnology industries strive to ensure the highest standards of container closure integrity, it is evident that traditional blue dye testing alone may not be sufficient to detect all potential risks. Fortunately, cutting-edge container closure integrity (CCI) methods offer superior sensitivity, reliability, and efficiency, surpassing the limitations of blue dye testing.

Packaging is a crucial aspect of the nutritional product industry, as it not only protects the product but also serves as a means to attract customers and communicate important information about the product. The packaging of nutritional products should be designed to preserve the quality, freshness and integrity of the product, while also being visually appealing, informative, and convenient for the consumer.

Nutritional product packaging can vary greatly depending on the type of product, its intended use, and the target market. Packaging materials can also play a significant role in the nutritional product industry, as they must be compatible with the product, safe for consumers, and sustainable. Some common packaging materials include plastic, glass, metal, and paper, each with its own advantages and disadvantages.

Most nutritional products are shelf-stable in nature; therefore, package performance is typically a concern. Chemical reactions occur naturally in all nutritional products. Any break or breach in the nutritional packing might lead to the products deteriorating due to air, moisture, and microbial exposure. Container closure integrity testing (CCIT) of nutritional products is vital to eliminating packaging defects and the possibility of product degradation. Read on to understand how PTI's VeriPac Flex Series guarantees the integrity of packaging for nutritional products.

Nutritional Package Inspection using VeriPac Flex System

VeriPac FLEX Systems are non-destructive inspection solutions for flexible packaging that deliver a clear PASS or FAIL as well as quantitative data that correlates to a leak rate. VeriPac FLEX Systems are available in several configurations for both the leak test instrument and the test chamber capacity to accommodate a wide range of package specifications and test sensitivity requirements, with solutions ranging from small format sachets and stick packs to very large bulk size pouches and bags.

They provide unparalleled sensitivity, reliability and practicality in testing a wide range of flexible package formats and is recognized by the FDA as a consensus standard for package integrity testing. The VeriPac tester is used to detect leaks in packages and is connected to the appropriate FLEX chamber based on the package size. There are several VeriPac configurations available with different leak detection capabilities depending on the application. The integrated flexible test chamber (IFC) is used for sachets or stick packs with low headspace, while the Drawer Style test chamber (D-Series) is available in sevearl standard sizes for other package sizes. Automated platforms for the VeriPac FLEX technology are also available for automated robotic handling of the pouches.

The VeriPac FLEX systems are unique in that they use a flexible membrane that conforms to the package shape and size, preventing stress and damage to the film materials. Multiple packages can be tested at once in a single test cycle. Custom designs can also be manufactured for large package formats and bulk products.

Benefits of VeriPac Flex Series

The test method is deterministic and quantitative.

It is non-destructive, non-subjective, and requires no sample preparation.

The method can test multiple packages in a single test cycle.

It is a cost-effective method that offers a rapid return on investment.

The method supports sustainable packaging and zero waste initiatives.

It simplifies the inspection and validation process.

The results are accurate and repeatable.

The method conforms to ASTM test method and FDA standard

Medical device package inspection is the process of evaluating the quality and integrity of the packaging of medical devices to ensure that they are safe for use. The packaging of medical devices is critical, as it protects the device from damage during shipping and handling, prevents contamination from external sources, and maintains the sterility of the device until it is used.

The package inspection process involves examining the packaging for any defects or damage that could compromise the integrity of the device. This includes checking for punctures, tears, or holes in the packaging material, as well as inspecting the seals and closures to ensure that they are secure and intact.

Medical device manufacturers are required to adhere to strict regulations and standards to certify that their packaging meets the necessary quality and safety requirements. Package integrity testing is an essential part of this process, as it helps identify any potential defects or issues with the packaging before the device reaches the end user.

Destructive vs Non-destructive Package Integrity Testing

Destructive package integrity testing involves damaging the package in some way to evaluate its integrity. This type of testing is typically more invasive and may not be suitable for products that need to be sold intact. An example of destructive package integrity testing is burst testing, where the package is subjected to internal pressure until it ruptures.

Non-destructive package integrity testing, on the other hand, involves evaluating the package's integrity without damaging it. This type of testing is typically less invasive and is more suitable for products that need to be sold intact. An example of non-destructive package integrity testing includes pressure decay testing, where a package is subjected to a pressure change and any leaks are detected by measuring the change in pressure.

Package Integrity Testing using Vacuum Decay Technology

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) that provides a definite pass/fail quantitative data along with dependable, reproducible, repeatable, and accurate results. The basic idea underlying Vacuum Decay technology is to question the integrity of containers based on their basic physical characteristics. Sample packages are first put into an evacuation test chamber that is tightly fitted and has an external vacuum source. A predetermined vacuum level is selected for the test based on the test sample and required level of sensitivity. The next step is to evacuate the test chamber and test system dead space for a certain amount of time. Differential pressure transducers are used to track changes in vacuum level over time. A pressure increase above the specified pass/fail limit indicates that the container is leaking.

Benefits of Vacuum Decay technology:

• Non-destructive, non-subjective, no sample preparation.
• Accurate, reliable, repeatable results.
• Definite pass/fail result based on quantitative test data.
• Accommodates multiple packaging formats.
• Eliminates destructive, subjective testing methods.
• Effective in detecting even minute leaks.

Packaging is an essential aspect of the meat snack product industry. Proper packaging helps maintain the quality, safety, and freshness of meat snack products, which is important for both consumer satisfaction and safety.

Modified Atmosphere Packaging (MAP) Tray Packs are a popular packaging method for fresh beef, pork, and poultry products, as well as for many other processed meats. Modified Atmosphere Packaging is a packaging technique that involves altering the composition of the atmosphere inside a package to extend the shelf life of the product. The goal of MAP is to slow down the natural degradation process of food by reducing the amount of oxygen inside the packaging and increasing the number of other gases, such as nitrogen or carbon dioxide. MAP has been widely used in the food industry for many years and is particularly useful for fresh fruits, vegetables, and meats. By reducing the amount of oxygen in the package, the growth of bacteria and fungi is slowed down, which helps to preserve the quality of the product for a longer period of time.

Advantages of MAP include:

1. Extended shelf life: MAP can significantly increase the shelf life of perishable foods, reducing the risk of spoilage and food waste.

2. Improved food safety: By creating an environment that inhibits the growth of microorganisms, MAP can reduce the risk of foodborne illnesses.

3. Reduced need for preservatives: With a longer shelf life, there is less need for the addition of chemical preservatives, which can be harmful to health.

4. Maintained food quality: MAP can help maintain the color, texture, and flavor of the food, which improves customer satisfaction.

How to Ensure Package Integrity of Meat Products.

The integrity of meat snack products can be tested using various methods including visual inspection, microbiological testing, or other non-destructive Container Closure Integrity Test (CCIT) methods. In this blog we will discuss how Vacuum Decay technology can be used to test the integrity of meat products

Vacuum Decay is a test method that has been proven over decades and further improved with new technological innovations. It involves drawing vacuum on a package within a test chamber and monitoring the vacuum level for decay, which would indicate a leak. The method established itself as a non-destructive replacement to the water bath leak test. It provides significant savings by not wasting product on a leak test and generates a return on investment in under six months for many products.

Vacuum Decay's acceptance as a regulatory tool is evident, and continued development optimizes the technology so that it can do more, perform better, and perform faster. PTI’s next generation of improvements are not incremental improvements, but rather foundational shifts in how the technology will serve the food, pharmaceutical, and medical device industries.

The next generation of VeriPac test systems has undergone a technology overhaul across the product line, improving each model to better perform for their respective applications. Innovation in the field of vacuum decay has often been focused on improving the practicality and sensitivity of the test method. The next generation of VeriPac systems combine both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls, and processing algorithms, the VeriPac Vacuum Decay Technology is establishing itself as the foremost vacuum-based leak detection technology.

Benefits of Vacuum Decay technology:

• Non-destructive, non-subjective, no sample preparation.
• Capable of detecting defects down to 0.05 ccm.
• Accurate, reliable, repeatable results.
• Supports sustainable packaging and zero waste initiatives.
• FDA recognized standard for package integrity testing .
• Accurate, reliable, repeatable results.
• ASTM test method F2338

PTI is a group of researchers, engineers, and professionals who are dedicated to enhancing the overall package quality experience over the course of the packaging lifecycle. To ensure container closure integrity, PTI has created and developed a number of inspection technology platforms. Each technology is based on the principle that there cannot be a test method without a valid test method. The technology solutions provided by PTI are centred on container closure integrity and give a deterministic measurement of package performance needed by critical applications. By delivering package performance data from the development stage to in-production online package inspection, the solutions are widely utilized to address a variety of packaging design and material difficulties.

List of CCI and Package Integrity Techniques Offered by PTI:

1. Vacuum Decay Technology

Vacuum Decay is one of the most practical and sensitive vacuum-based leak detection techniques. This test provides the most accurate, repeatable, and reliable quantitative results, along with a pass/fail determination. The ASTM F2338 standard vacuum decay test method was developed using PTI’s VeriPac instruments. Additionally, it is recognized in the United States Pharmacopeia Chapter on CCI and classified in ISO 11607. The non-destructive container closure integrity testing (CCIT) method from VeriPac can use a differential pressure or absolute pressure transducer leak test device to find package leaks and undetectable defects.

2. Microcurrent HVLD Technology

PTI packaging and inspection systems transformed the traditional HVLD method and offered a new technology for assessing the integrity of all parenteral and biological products, including low conductivity liquids such as sterile water for injection (WFI). When compared to standard HVLD solutions, this innovative technology, known as Microcurrent HVLD, uses approximately 50% less voltage and exposes the product and environment to less than 5% of that voltage. The Microcurrent HVLD test method may detect and locate pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other defects.

3. Helium Leak Detection Technology

Helium leak testing is the process of identifying leaks in various enclosed or sealed systems by utilizing helium as a "tracer" gas and measuring the concentration of the gas as it escapes as a result of a leak. Because it is non-toxic, non-flammable, non-condensable, and its atmospheric concentration is less than 5 ppm, helium is utilized as a tracer gas. Helium can pass through almost any cracks or openings since it is the second-smallest molecule in the periodic table. Additionally, helium is relatively safe to use because it does not react with other substances. This method uses a mass spectrometer leak detector (MSLD), also known as a helium leak detector, to locate and measure the leak.

4. Airborne Ultrasound Technology

PTI's proprietary Airborne Ultrasound technique is a non-destructive, non-invasive seal quality inspection method. Airborne Ultrasound technology offers thorough seal quality studies and is applicable to a wide range of packaging materials, including: Tyvek, paper, foil, film, aluminium, plastic, and poly. Defects of many forms, visible and invisible, leaking and non-leaking, process-related and random, can be detected. Airborne Ultrasound technology is an ASTM Test Method F3004 and an FDA-approved standard for testing seal quality.

5. Volumetric Imaging Technology

The OptiPac One-Touch Tool-less technology is intended for non-destructive leak detection of blister packages. To identify leaks, the OptiPac uses volumetric imaging technology to measure the motion of a blister package under vacuum. With new blister package formats, the interface is practical and straightforward to set up, requiring no tooling changeover or extensive parameter modifications as seen with previous non-destructive blister package inspection systems. The system collects volumetric data from each cavity, responding to variable cavity shapes, sizes, and configurations of various blister pack forms.

6. Force Decay Technology

Force Decay is a quantitative package integrity testing approach that is well-suited for low-headspace packaging. Non-porous materials, such as films, laminates, or foils, can be used in packaging formats. It does not harm or modify the sample packages because it is a non-destructive test method. When the test is finished, the packages can be returned to the batch without being discarded. The 410's force decay technology can measure force from a package's surface deflection during a conventional vacuum-based test cycle. VeriPac 410 force decay technology has been validated on a variety of package types, including: blister packs, transdermal patch sachets, and low headspace suture packs.

PTI’s continuous technology development has brought more technology and measurement solutions to market under one brand. Whether it be helium leak detection, high voltage leak detection, airborne ultrasound, or a vacuum-based solution, PTI - Science of Quality is the think tank you can rely on to provide the highest level of technology solutions for package quality. PTI continues to build on our journey, and we look forward to supporting you on yours.

Biological drug products are complex, large-molecule drugs that are derived from living organisms or their components. They are designed to mimic, augment or replace the function of naturally occurring molecules in the body. These drugs are often produced through biotechnology, which involves manipulating living cells to produce specific proteins or other molecules.

Examples of biological drug products include monoclonal antibodies, recombinant proteins, vaccines, and gene therapies. These drugs are used to treat a wide range of diseases, including cancer, autoimmune disorders, and genetic diseases.

Biological drug products are often more expensive than traditional small-molecule drugs because they are more complex to manufacture, require specialized facilities, and are subject to rigorous testing and regulatory requirements. However, they can also provide more targeted and effective treatments for certain conditions.

Package integrity testing is an essential part of ensuring the safety and efficacy of biologics. Any damage or compromise to the packaging of biologics can lead to degradation or contamination, which can impact their efficacy and safety. The choice of method depends on the specific biologic being packaged, the type of packaging used, and the regulatory requirements. It is important to perform Container Closure Integrity tests (CCIT) solutions. at multiple stages of the manufacturing process to ensure that the biologic remains safe and effective from production to patient use.

CCI Testing of Biologics using E-Scan MicroCurrent HVLD

The E-Scan 655 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. The E-Scan 655 technology is a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions.

The E-Scan MicroCurrent HVLD technology is often used in the pharmaceutical industry for detecting leaks in parenteral drug products, such as vials and syringes. E-Scan MicroCurrent HVLD technology is considered to be a reliable and efficient method for leak detection, ensuring the integrity of the drug product and patient safety.

The technology uses a non-contact and non-invasive test method that requires no sample preparation. The E-Scan 655 features a fast test cycle and simple operation. Additional benefits include quick changeover and easy recipe setup to accommodate a wide range of products and applications. E-Scan MicroCurrent HVLD technology can be migrated from laboratory to 100% inline production applications.

Benefits of E-Scan MicroCurrent HVLD

• Non-destructive, non-invasive, no sample preparation.
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI).
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection.
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
• Simplifies the inspection and validation process.

To ensure container closure integrity, PTI - Packaging Technologies & Inspection, with headquarters in Hawthorne, New York, has created and developed seven different inspection technology platforms. The technology solutions provided by PTI are centered on container closure integrity and give a deterministic measurement of package performance needed by critical applications.

Overview of technologies offered by PTI

• Vacuum Decay technology for pharmaceutical package inspection.
• Airborne Ultrasound technology for seal quality testing and analysis.
• MicroCurrent HVLD technology for high-risk parenteral applications.
• OptiPac volumetric imaging inspection technology for blister packaging.
• Automated container closure integrity testing CCIT solutions.

Industry Applications of PTI Technologies 1. Pharmaceutical

While operating under heightened legal and regulatory scrutiny, the pharmaceutical industry continues to be at the forefront of innovation in the domains of new drugs and drug delivery techniques. It is crucial that these products have extremely sterile packaging because they are used for life-saving purposes and must be completely free of contaminants for the duration of their shelf life until they reach the patient. PTI Inspection Systems' tools for testing pharmaceutical packaging are the most sensitive, dependable, and effective. PTI technologies produce quantitative test result information and are deterministic, non-destructive test methods.

2. Biotech

The biotech sector encompasses a wide range of medical techniques, including tissue regeneration, genetic editing, and stem cell therapy. Parenteral packaging, such as pre-filled syringes, vials, IV bags, and other single-use bags, are generally used to package these medications. Testing the integrity of container closures is crucial for guaranteeing the quality of all biologics, especially parenterals. PTI's technologies are the most dependable and trustworthy options available for pharmaceutical and biotech packaging applications where the results have a significant impact on stability tests, clinical trials, production performance, and patient safety.

3. Medical device

The medical device sector is critical to the health care system since it is involved in the delivery of numerous health care services. Over the last few decades, remarkable advances in medical technology have posed a challenge to the medical device packaging industr in terms of ensuring packaging quality and reliability. Although assessing package quality is crucial for all medical devices, it is especially critical for Class III medical device products. Therefore appropriate package integrity testing technologies are needed to ensure standardized packaging quality.

4. Nutrition

The nutritional market is progressive and dynamic and nutritional packages play a vital role in delivering the product safely. Most of the nutritional products are shelf-stable in nature and this is often the function of package performance. All nutritional products are subject to innate chemical reactions. Products deteriorate with the exposure to oxygen, moisture and bacteria. PTI has decades of experience designing technologies to inspect food and nutrition packages in the most efficient way possible while ensuring package and product quality. PTI is a pioneer in meeting the needs of infant nourishment packaging applications as well as the demanding specifications of this high-risk product.

PTI provides a comprehensive range of technologies for the industries indicated above. However, it is important to note that there are no one-size-fits-all solutions. Technologies that work in one field may not work in another. As a result, before finalizing any technology, manufacturers should assess industry requirements.

PTI - Packaging Technologies & Inspection - is a group of scientists, engineers, and packaging professionals who are working to improve the overall package quality experience throughout the packaging lifecycle.

To ensure container closure integrity, PTI has designed and developed seven different inspection technology platforms. Each technology is based on the idea that there cannot be a test method without a valid test method. The technology solutions provided by PTI are centred on container closure integrity testing and give a deterministic measurement of package performance needed by critical applications. By delivering package performance data from the development stage through to in-production online package inspection, the solutions are widely utilized to address a variety of packaging design and material difficulties. PTI offers services and consulting in package inspection technologies, container closure integrity and test methods for most of the package types.

List of Services Offered by PTI:

1. Feasibility Studies

The first step in assessing and choosing the optimal CCI technology and test technique for a particular application are feasibility studies. To examine and verify the performance and quality of a package, various test methods are available. The main goal of the feasibility study is to assess the client's application and identify the best inspection technology that will deliver the most precise, sensitive, and reliable data for conclusive package integrity verification.

Clients receive a clear report of a quantitative test technique from PTI's feasibility studies for container closure integrity testing (CCIT) and package quality inspection, which confirm the suggested strategy as it applies to a particular package format. Both positive control samples with certified defects and tested good test samples are used. The technology solution, a specific leak test technique, test settings, test result information, and acceptance criteria are all detailed in the report. The report on PTI's feasibility studies outlines a clear path from the client's problem description to the quantitative test methodologies and findings, as well as how to guarantee package integrity by validating a suggested strategy in relation to a particular package format.

2. Test Method Consulting

Engineers, scientists, and other specialists on PTI's staff are experts in developing test methods, consulting on them, and conducting feasibility studies for a range of applications. The report on PTI's feasibility studies outlines a clear path from the client's problem description to the quantitative test methodologies and findings, as well as how to guarantee package integrity by validating a suggested strategy in relation to a particular package format.

3. Technical Support

PTI service specialists offer remote help via a variety of virtual channels in addition to on-site service. Installation, calibration, training, and upgrades are among the remotely offered services of PTI. The GTS staff can adapt to your demands regarding service schedule. Installations, validation, and after-sale support and maintenance are all skills, our staff have received training in. This network provides services to a varied range of markets around the world.

The ability of container closure systems to maintain a sterile barrier against potential contaminants that could lower the quality of the finished product can be understood as container closure integrity. External contaminants may enter the product through even the smallest leak or breach of the sterile barrier, impairing its capacity to perform as expected. Despite being popular leak testing techniques, dye ingress and microbial ingress have been shown to produce results that are often inaccurate and subjective. Deterministic test methodologies that can be controlled, calibrated, and provide a firm determination of CCI have therefore been encouraged by regulatory bodies.

Vacuum Decay is a non-destructive container closure integrity testing (CCIT) method for detecting leak paths and package integrity. The test method is simple in principle and challenges container integrity based on fundamental physical properties. This test provides a quantitative result that is accurate, repeatable, reproducible, and reliable with a pass/fail determination.

Our line of non-destructive VeriPac package testing equipment is backed by the tradition of excellence and performance reliability that PTI brings. The FDA acknowledges the standard Vacuum Decay leak test method (ASTM F2338), which was created using PTI's VeriPac instruments, as a consensus standard for testing container closure integrity (CCI). The test method is referenced in the United States Pharmacopeia Chapter on CCI and listed in ISO 11607 (USP Chapter 1207). The test is conducted by drawing vacuum on a package inside of a test chamber, and the vacuum level is checked for any decay that might signify a leak. The technique has established itself as a non-destructive substitute for the water bath leak test. By avoiding product waste for a leak test, it offers significant savings and, for many products, achieves return on investment in less than six months.

Industry Applications:

1. Pharmaceutical Industry

Pharmaceutical manufacturers prioritize quality control and package integrity because defects in pharmaceutical product manufacturing can directly affect drug quality. Even minor defects in the packaging or container may allow outside elements or contaminants to enter the drug. A manufacturer prioritizes implementing the proper container closure system because it affects both the product and the patient. CCI testing is a non-destructive package inspection technology for detecting leaks and avoiding potential contamination. The regulatory bodies take CCI's negligence very seriously. The guidelines support deterministic, dependable test methods for measuring industry-wide quality standards.

2. Food and Nutrition Industry

Packaging is crucial to today's food and nutrition industry. Packaging serves a variety of purposes, including product safety, brand awareness, product promotion, product protection and product delivery. Food and nutrition products are packaged so that they stay fresh for the entire shelf life. However, the challenges associated with packaging food and nutrition products have increased due to frequent innovations in packaging formats and the move towards sustainable packaging materials.

In order to ensure that the products are free from any type of contamination or defect, manufacturers are encouraged to perform appropriate package integrity tests. Various Container Closure Integrity Testing techniques are now available on the market to guarantee the quality and sterility of packages for the duration of their shelf life or until they are delivered to the consumer. Vacuum Decay technology and Airborne Ultrasound technology, among other methods, are very useful in food and nutrition package inspection.

Benefits of Vacuum Decay Technology

• Non-destructive, non-invasive, no sample preparation
• Accurate, reliable, repeatable results
• Supports sustainable packaging and zero waste initiatives
• FDA recognized standard for package integrity testing
• ASTM test method F2338

It is critical that medical fluid bags and valves do not leak. IV bags, blood bags, and drainage collection bags are all examples of medical fluid bags. IV bags contain electrolytes and medications that flow from the bag into the patient's vein via a tube and a needle to provide them with life-sustaining fluids. The Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have established strict guidelines for testing container closure systems in order to ensure the safety of sterile products like IV bags. Testing these bags for leaks is critical because leaks can risk the overall sterility of the container and thus user safety.

IV Bags Testing using VeriPac 455 Series

VeriPac Vacuum Decay technology is regarded as a highly effective method for evaluating the integrity of liquid filled IV bags. This technology is recommended by UPS 1207 and is an FDA (Food and Drug Administration) consensus standard for Container Closure Integrity testing (CCIT) of high-risk package applications with fast, repeatable and reliable test results that provide quantitative and deterministic quality assurance. Being a non-destructive technique, Vacuum Decay offers a greater understanding of the packages and reduces waste. Irrespective of the defect location, this technology system can pick up both large and small defects. Additionally, PTI VeriPac system ensures leak detection and eliminates false positives by providing quantitative test data.

IV bags can be evaluated effectively using VeriPac 455 leak detection system. It is a non-destructive, non-invasive method that requires no sample preparation. Apart from package integrity testing, VeriPac 455 can be used for stability studies, clinical trial studies, quality assurance testing and production statistical process control (SPC).

Technology Overview

Under this method, a test chamber that is specifically designed to hold the package being evaluated is connected to the VeriPac 455 leak tester. The package is placed inside the test chamber to which vacuum is applied. The test chamber is observed for both vacuum level and change during a defined test time using the dual transducer technology. The presence of leaks and defects within the package is identified by monitoring changes in absolute and differential vacuum. VeriPac 455 series is designed for manual or automatic operation, and it is suitable for laboratory offline testing and QA/QC statistical process control.

Benefits of VeriPac 455 Series

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard

There are certain aspects that need to be maintained regardless of whether you operate in the food packaging sector or the pharmaceutical products manufacturing industry to ensure that a quality product will be provided to the clients. Package integrity testing is required for items that must be packaged so that they can be sterilized and maintained sterile for a defined amount of time, throughout the product lifecycle.

Package Integrity Testing Using VeriPac 455

The VeriPac 455 is a non-destructive, non-invasive, and highly sensitive Container Closure Integrity Testing (CCIT) method that may be implemented into protocols at any stage of the handling process. Stability research, clinical trial investigations, quality assurance testing, and production statistical process control are examples of applications for this technology (SPC). Leak rates as low as 0.05 cc/min can be found with the VeriPac 455. Results have consistently outperformed and outperformed the dye ingress test in terms of accuracy.

The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 455 is equipped with the patented PERMA-Vac dual vacuum transducer technology, which increases test sensitivity and yields reproducible, dependable results.

Additionally, the VeriPac 455 contains major improvements in networking and internet access that enable remote operation, system monitoring, and MES integration. Test systems can be built to operate automatically or manually. This inspection method is appropriate for QA/QC statistical process control and laboratory offline testing. The test cycle only lasts a few seconds, the results are objective, and the testing is non-destructive to the product and the package.

Inspection Criteria

• Measures seal integrity of entire container or package
• Measures and verifies container closure system integrity
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, pre-filled syringes)

Benefits

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method F2338 and FDA standard for package integrity testing
• Vacuum Decay technology referenced in USP 1207 guidelines

A combination product may be defined as 'a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.' In simple words, a combination product is a combination of at least two product categories such as drug, device and/or biological products. Best-known examples of combination products include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. Often termed as high-risk medical devices, combination products host various challenges for manufacturers, demanding in-depth testing and evaluation. Read on to know how manufacturers can test the integrity of combination product packages using helium leak detection.

Package Integrity Testing using Helium Leak Testing

Helium leak detection is a highly effective technique for evaluating the integrity of a wide range of complex pharmaceutical and parenteral products. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, cold form blister packs, foil pouches and many other package formats. This technology can precisely determine integrity between specific primary container closure system components, making it an ideal choice for testing the integrity of pharmaceutical products.

Why is Helium used as a Tracer Gas?

• Helium is used as a tracer gas because of certain unique qualities that make it ideal for leak testing.
• Non-toxic, non-condensable, non-flammable.
• Helium gas is inert, which means it does not interact with the components being tested.
• Since the atomic size of helium is really small, it can easily breach through pathways reliably and easily.
• Compared to other tracer gases, helium is less expensive and readily available.
• Its presence in the atmosphere is not more than ppm.

How Does Helium Leak Detection Technology Work?

The test procedure begins by filling the package with helium, which is then subject to vacuum. Then, the amount of helium escaping from the package is quantitatively measured using a helium leak detector. This is then stated as the leak rate. Apart from leak testing, helium leak detection technology is also suitable for package design, failure analysis, tooling qualification, packaging line setup and validation, and product quality monitoring. Helium leak detection per ASTM F2391, is a well-established method recognized and widely used in the pharma industry.

Applications of Helium Leak Testing

• Ensuring Container Closure Integrity
• Selecting closure formulation and configuration
• Seal integrity monitoring during stability studies
• Extremely valuable in early-stage pharmaceutical product package system development
• Continuous product quality monitoring

Blister packs are pre-formed packaging that are commonly used for tablets, capsules and certain consumer goods. They are made up of two primary components - a cavity made from a form of plastic or aluminum and a covering made from aluminum, paper or a lamination of soft foil. The cavity holds the product while the covering seals the product in the package.

While filling tablets into blister packs, the product is first fed into the desired cavities followed by sealing the cavity covering. Manufacturers of sterile pharmaceuticals highly depend on package integrity testing to verify product quality and safety.

Package Inspection Techniques

1. OptiPac Leak Detection System

OptiPac Leak Detection System is a non-destructive container closure integrity testing method developed specifically for multi-cavity blister packs. This leak detection method uses One-Touch Technology to achieve a rapid test cycle without requiring any changeover or sample preparation. Practical operation, sensitivity and reliability are the key features that make OptiPac technology ideal for blister package inspection.

To conduct the test, the operator places the blister pack on the test plate and presses the start button. The next step involves pulling vacuum to the desired vacuum level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If the pack is defective, the air escapes into the chamber leaving a collapsed blister cavity. Depending on the blister cavity, OptiPac technology provides rapid detection of upto sub-5-micron defects. Additionaally, the technology displays a definitive pass/fail result along with quantitative measurement for each package tested.

2. VeriPac 410 Series

The VeriPac 410 inspection system utilizes a combination of Vacuum Decay technology and differential force measurement for container closure integrity test (CCIT) and leak detection of blister packs, sachets, and pouches with low headspace, such as transdermal patch packaging and suture packs. This technology can be used to test multiple packages in a single test cycle based on the package specifications. Additionally, it can also precisely identify which package or blister cavity is defective. VeriPac 410 inspection systems are proven to provide quantitative test results with a definitive pass/fail result. Being a non-destructive technique, VeriPac 410 allows tested products to be returned to the production line. This eliminates the cost and waste associated with destructive leak test methods. The ROI for the VeriPac 410 makes this a powerful solution for the pharmaceutical industry.

Benefits of VeriPac 410 Series

• Non-destructive, non-invasive, no sample preparation
• Non-subjective, accurate and repeatable results
• Capability to test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA standard
• Cost effective with rapid return on investment
• Scalable to automated inline testing.

Evaluating the ability of the container closure system to provide a sterile barrier and prevent leaks resulting from contamination is a crucial step towards maintaining the safety and suitability of primary packaging. United States Pharmacopeia (USP) and Food and Drug Administration (FDA), the driving forces behind container closure systems in the US, enforce strict regulations for Container Closure Integrity Testing (CCIT).

Traditionally, Dye Ingress and Microbial immersion were two popular methods to evaluate container closure integrity. However, they were probabilistic methods that lacked accuracy and provided subjective test results. In 2016, USP issued guidelines that they preferred deterministic test methods over probabilistic test methods. Examples of deterministic test methods include Vacuum Decay technology, Airborne Ultrasound technology, Helium Leak Detection etc. In this blog, we will discuss the role of VeriPac 355, which is a Vacuum Decay technology in testing container closure integrity.

CCI Testing Using VeriPac 355 Technology

The VeriPac 355 is a non-destructive technology based on the ASTM vacuum decay leak test method (F2338-09) and is recognized by the FDA as a consensus standard for package integrity testing. This micro leak detection system is applicable across a wide range of packaging formats and is specially designed to test containers for gas leaks for dry products (lyophilized vials, powder-filled) as well test for liquid leaks (non-protein based liquid-filled vials, prefilled syringes). The non-destructive nature of the technology allows it to be incorporated into protocols at any point in the handling process. VeriPac 355 technology's capability of detecting leak rates as low as 0.2 cc/min makes it an optimal quantitative test method for many pharmaceutical and food applications.

VeriPac 355 Working Principle

The VeriPac 355 leak tester is connected to a test chamber designed specially to hold the package being tested. Vacuum is then applied to the package inside the test chamber. Using a high-resolution absolute transducer technology, the test chamber is monitored for the level of vacuum as well as the change in vacuum over a predetermined test time. Although the test cycle takes only a few seconds, it produces accurate and non-subjective test results. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or semi-automatic operation. This inspection method is suitable for laboratory offline testing and QA/QC statistical process control.

Inspection Criteria

• Measures seal integrity of entire container or package
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, prefilled syringes)

Benefits of VeriPac 355 Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Measures seal integrity of entire container or package
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, prefilled syringes)
• Measures and verifies container closure system integrity
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard

Testing the integrity of newly developed packaging is a critical step in ensuring that it serves its requirements in every situation. Packaging needs to ensure that it sustains physical and mechanical stress and keeps the contents fresh until they reach the end user. In order to understand how packaging behaves under different circumstances, flexible packaging testing is quite important. Procedures for testing flexible packs are quite different from rigid packaging. Compared to rigid packaging, flexible packaging can present unique challenges in how to test both the integrity of the package and the seal quality. Some of the solutions offered for flexible package testing by PTI.

Flexible package integrity testing techniques

1. VeriPac Flex System

PTI's VeriPac FLEX systems are versatile non-destructive CCIT methods, designed specifically for pouches and other flexible packaging with dry-filled products. The technology utilizes an ASTM method for vacuum decay leak testing (F2338) listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing. PTI's VeriPac FLEX Systems are available in several configurators that can accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags. A unique feature of this technology is that it requires no changeover of settings or tooling and is proven to provide high levels of sensitivity, reliability and practicality in testing a complete range of flexible packaging formats and sizes.

Technology Overview

The test begins by connecting the VeriPac tester to the appropriate FLEX chamber based on the size range of the package. The two VeriPac systems paired with the FLEX chamber provide different leak detection capabilities depending on the application. While the integrated flexible test chamber (IFC) is intended for sachets or stick packs with low headspace, the Drawer Style test chamber (D-Series) is ideal for package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials. Multiple packages can be tested in a single test cycle.

Benefits of VeriPac Flex System

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Test multiple packages in a single test cycle.
• Cost effective with rapid return on investment.
• Supports sustainable packaging and zero waste initiatives.
• Simplifies the inspection and validation process.
• Accurate and repeatable results.
• ASTM test method and FDA standard.
• USP < 1207> compliant

2. Airborne Ultrasound Technology

PTI's Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals’ strength are analyzed. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is a deterministic, quantitative method that inspects the final pouch seal non-destructively 100% online. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and many common defects in seals that appear visually acceptable yet possess defects that affect product quality, value and shelf-life.

Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline for in-depth seal quality evaluation and analysis. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis.

Advantages of PTI’s Seal Scan and Seal Sensor Method:

• Deterministic seal quality inspection method that produces quantitative results.
• This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
• Non-destructive and non-subjective test method that requires no sample preparation.
• Technology can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable, reproducible and reliable results for seal quality inspection.
• Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.

Most powder dairy products (milk powders, infant formula, protein-based powders, etc.) require process monitoring, production control and modified atmosphere packaging (MAP) to retain their quality throughout its shelf-life or until it reaches the end-user. However, products that use MAP often have high risks of deficiencies in package quality control. Most MAP applications use Nitrogen flushing, and testing package quality involves sampling package gas content days after the product has been packaged. The protein based content of many products will allow bacteria to consume the majority of the O2 content before the increase in O2 is detected by gas testing equipment. Leaks as small as 10-20 microns will only increase the oxygen content to levels below 3%, the typical pass/fail threshold, passing defective product. Although packaging integrity testing can be conducted using traditional methods like water bath, they are only sensitive to 25-micron leaks at best. Therefore, dairy product manufacturers should use testing methods that offer highly sensitive leak testing along with the highest level of quality assurance.

Package Testing using VeriPac Test System

Vacuum Decay has been verified as the most practical and sensitive vacuum based leak test method. It is capable of creating reliable and accurate quantitative results and a pass or fail determination. The standard Vacuum Decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the Food and Drug Administration (FDA) as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). VeriPac series are a practical alternative to destructive testing methods that provide subjective test results and variable test standards.

PTI brings a tradition of excellence and performance reliability to our line of VeriPac non-destructive package testing equipment. PTI's VeriPac Series has the capability to non-destructively test packages at the production line with high levels of accuracy and sensitivity. Non-destructive testing not only reduces wastage, but it also allows operators to have a greater understanding of package quality. Moreover, it can accommodate multiple package formats and requires non changeover when testing different size packages.

Technology Overview

Under this technique, the VeriPac leak tester is connected to a test chamber that contains sample packages. Vacuum is applied to these packages and a dual transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package.

VeriPac Inspection system:

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Defect detection down to 0.2 ccm.
• High level of sensitivity, repeatability and accuracy.
• Short cycle time provides operator with PASS/FAIL result.
• Small footprint and modular portable design.
• ASTM test method and FDA standard.
• Referenced in USP 1207 guidance.

Finding the appropriate packaging for perishable foods can be quite challenging for manufacturers. Apart from considering factors such as vulnerability and freshness, a food package must ensure safety throughout its shelf life or until it reaches the end-user. To ensure that the contents are not exposed to any foreign contamination, manufacturers should conduct regular tests that can evaluate the ability of the packaging in maintaining seal integrity. Package integrity testing can pinpoint the exact location of leaks which helps operators identify the problematic area and make necessary adjustments. As a result, manufacturers can be sure of the packaging quality and ensure that the customers enjoy their products in the freshest possible state.

For inspecting package integrity of food products, PTI has developed VeriPac 310 series, a non-destructive, non-invasive Container Closure Integrity Testing (CCIT) system for highly effective leak detection. It is an ASTM approved patented vacuum decay leak test method F2338-09 recognized by the FDA as a consensus standard for package integrity testing. The VeriPac 310 provides quantitative measurements for identifying package defects before critical process issues get out of control. The tests can be performed in any sequence with real-time results.

VeriPac 310 series was developed using VeriPac leak test instruments. The next generation of VeriPac systems combines both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls and processing algorithms, the VeriPac technology is establishing itself as the foremost vacuum-based leak detection technology. VeriPac systems reduce waste and provide operators with a clear understanding of package quality.

Technology Overview

Under this method, VeriPac leak testers are connected to the test chamber designed to hold the sample packages. Vacuum is then applied to the package being tested. The absolute transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. VeriPac 310 test systems are suitable for manual or automatic operation and are designed for laboratory offline testing and production applications for QA/QC statistical process control. Testing is more reliable, sensitive and efficient than destructive methods such as the water bath or burst test.

Benefits of VeriPac 310 Series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Repeatable, rapid and reliable testing
• Cost effective and economical
• Simplifies the inspection and validation process
• ASTM test method and FDA standard

Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

1. Airborne Ultrasound technology

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

2. Vacuum Decay technology

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

Ensuring the integrity of product packages is of utmost priority to snack food manufacturers. On-the-go snack products like wafers, chips, jerky,and coffee are vulnerable to deterioration by organic components such as moisture or air. Such foreign contaminants can enter the product through defective packages and accelerate the food decomposition process. In fact, mold, oxidation, flavor degradation, and spoilage are often the direct result of compromised package integrity. These factors can create a negative impact on consumers’ perceptions of a product and brand.

It is vital for manufacturers to ensure that packaged products are properly tested for integrity to insure that products remain fresh until they reach the consumer. Today, the market offers a wide range of leak testing that is both destructive and non-destructive. However, manufacturers should realize that a method applicable for one is not ideal for another. The leak testing method chosen should be based on the specific package specification and defect rate detection. Read on to know in detail about snack food packaging integrity testing method offered by PTI.

Package testing using PTI VeriPac Vacuum Decay Series

PTI's VeriPac inspection systems are ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. Vacuum Decay technology is a container closure integrity test (CCIT) method, referenced in the new USP <1207> Chapter Guidance as a deterministic test method for package integrity testing. This method is also listed in ISO 11607.

VerIPac test systems have a proven capability to non-destructively test a wide range of packaging formats without requiring any changeover when testing different size packages. Additionally, it is also possible to test multiple packages in a single test cycle. VeriPac provides a qualitative result (PASS or FAIL) as well as quantitative data that correlates to leak rate and leak size. Being a non-destructive method, the test allows non-defected packages to be returned to the production line, thereby reducing waste and improving testing capabilities. This makes it a practical alternative to destructive testing methods like water bath and dye ingress.

Technology Overview

The process begins by connecting VeriPac leak testers to a test chamber specifically designed to hold the sample package. Vacuum is applied to the package being tested. Using a single or dual vacuum transducer technology, vacuum levels, as well as changes in vacuum over a predetermined test time, are monitored. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. VeriPac test systems are suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle takes only a few seconds, is non subjective, and non-destructive to both product and package.

VeriPac Inspection system:

• Non-destructive test method that ensures quantitative test results
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Supports zero waste initiatives

Medical devices are available in a variety of forms with complex geometric attributes such as valves, tubes and others that can complicate the medical device testing process. Hence, medical device leak testing equipments are expected to provide high levels of sealing effectiveness and test result sensitivity to narrow down the complexities.

Medical Device Package testing using Seal Scan technology

Seal-Scan® is a deterministic, quantitative, high-resolution method based on is an Airborne Ultrasonic Technology (ABUS). It is highly effective in non-destructively inspecting and analyzing pouch seals for defects and seal integrity for consistency. Seal-Scan systems utilize the ASTM Test Method F3004-13, which is a non-destructive test method for evaluating seal quality and integrity using Airborne Ultrasound technology. The test procedure is simple, quick and requires no sample preparation. Additionally, Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis.

Seal-Scan features two scan modes:

• Linear Scan (L-Scan) to simulate online defect detection (line graph)
• C-Scan for detailed seal analysis, producing pixel by pixel evaluation of seal (Opto-Acoustic image)

Technology Overview

The test beings by scanning the pouch seal or package material between two focused ultrasonic sensors. Ultrasonic waves propagate through single or multiple layers of bonded materials. As the ultrasonic waves propagate through different mediums, it causes reflections of sound waves, which reduces/eliminates signal strength. The level of signal passing through the seal is a function of the quality of the seal. Various types of defects; leaking and non-leaking, process-related and random are detectable.

Seal scan has two scan modes (L-Scan and C-Scan) that is capable of producing Opto-Acoustic images as well as detailed statistical analysis. An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% fully automated on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Produces high resolution Opto-Acoustic image of seal.
• Characterizes overall quality and uniformity of the seal.
• ASTM Test Method F3004 and FDA recognized standard for seal quality inspection.

Medical devices and pharmaceuticals products are manufactured with zero tolerance to defects. For this reason, manufacturers give top priority to quality control procedures and regulatory standards. This is to make sure that products maintain the quality standards required for their intended use.

Packaging plays an important role in maintaining product quality and ensuring the product reaches consumers defect-free. While selecting the right packaging material is important, testing integrity of packages also holds high relevance. Traditionally, destructive testing methods like Dye Ingress and Water Bath were popular Container Closure Integrity Testing (CCIT) techniques. However, in recent years, the industry has moved towards deterministic methods to achieve more precise, reliable results.

How PTI's VeriPac Series ensure package integrity?

PTI 's VeriPac series are non-destructive, non-subjective test systems ideal for leak testing high-risk applications that require extreme levels of test reliability and accuracy. This technology uses an ASTM approved vacuum decay leak test method F2338, which is listed in ISO 11607, USP <1207>. It is an FDA recognized consensus standard for package integrity testing. Using cutting-edge innovation, VeriPac inspection systems provide repeatable, sensitive, and more robust detection of defects. VeriPac testers feature the patented PERMA-Vac manifold system and dynamic test modes that provide the ability to test a wide range of package formats including flexible, rigid and semi-rigid packaging. Apart from package integrity testing, VeriPac technology can also be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).

Technology Overview

The test method is initiated by connecting VeriPac leak testers to a test chamber that is specially designed to contain the package being tested. The package is placed inside the test chamber to which a vacuum is applied. Using a single or dual vacuum transducer technology, the level of vacuum as well as the change in vacuum over a predetermined test time are monitored. The variations in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or automatic operation. This inspection method is suitable for laboratory offline testing and production applications for QA/QC statistical process control. The test cycle takes only a few seconds, is non-invasive and non-destructive to both product and package.

Benefits of VeriPac series

• Deterministic, quantitative test method.
• Defect detection down to 0.034 cc/min.
• Highest level of repeatability and accuracy.
• Cost-effective with rapid return on investment.
• Simplifies the inspection and validation process
• Results proven superior to dye ingress.
• ASTM test method and FDA standard
• USP <1207> Compliant.

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile products intended to be administrated directly into human bodies. Parenteral drug products are expected to be free from microorganisms, pyrogenic substances as well as other visible particles. Contaminated parenteral drug products can cause serious health concerns to the patient. Hence, sterility assurance and package integrity testing are of paramount importance in parenteral drug manufacturing. Read on to know more about parenteral products package testing methods offered by PTI.

Parenteral products package testing methods:

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity test method primarily used to detect leaks in package seals. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection. Vacuum Decay technology has established itself as a non-destructive alternative to traditional test methods like Water Bath and Dye Ingress, making it a practical solution for leak detection in the Pharmaceutical and Medical Device industry.

How does Vacuum Decay technology work?

The principle behind Vacuum Decay technology is simple and it challenges container integrity based on fundamental physical properties. The test begins by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Based on the test sample and level of sensitivity required, a pre-determined vacuum level is chosen for the test. The next step involves evaluating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor changes in vacuum levels for a specified period. A pressure increase beyond the predetermined pass/fail limit indicates container leakage.

Benefits of Vacuum Decay technology

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data 
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods
• Effective in detecting even minute leaks
• ASTM Test Method F2338, FDA Consensus Standard and USP 1207 compliant
 

2. MicroCurrent HVLD Technology

PTI’s Microcurrent is patent-pending unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effective across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series is a leading solution of sturdy container closure integrity test equipment.

Benefits of MicroCurrent HVLD technology

• Non-destructive & requires no sample preparation
• Deterministic & non-invasive
• Highly effective across all parenteral products
• High levels of sensitivity, accuracy and reliability in results
• Offline and 100% online inspection at high production speeds
• Simplifies the inspection and validation process
• Referenced in Chapter USP 1207 Guidance for CCIT

Packaging is an essential part of the pharmaceutical industry, given the sensitive nature of the contents. High-risk medications and lifesaving drugs need utmost care and protection until they reach the patient. As such, stringent industry standards apply to pharmaceutical packaging. Manufacturers give high priority to safety and quality while selecting packaging materials for a drug or healthcare product. The packaging should be able to act as a barrier against external contamination and chemical reactions. Exposure to reactive gases can alter the physical, chemical and biological attributes of the products. This makes Container Closure Integrity Testing of pharmaceutical packaging a regulatory requirement.

Role of MicroCurrent HVLD in ensuring pharmaceutical package integrity

Often referred to as the conductivity and capacitance test, High Voltage Leak Detection (HVLD) is a test method found to be highly effective in detecting the presence and location of leaks in a wide range of pharmaceutical and parenteral applications. It can be used for leak testing in nonporous, rigid or flexible packages, as well as packages containing liquid or semi-liquid products. High Voltage Leak Detection test is conducted using electrical conductivity and resistance principle. This method operates by passing high voltage micro current signals through sample packages. Under the presence of a leak, the electrical resistance of the sample declines, causing an increase in current. Compared to other leak detection methods that rely on flow of gas or liquid, HVLD technology relies on “flow” of current. This reduces challenges with defect clogging compared to flow-based analysis.

The latest evolution of HVLD, PTI’s patent pending MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of pharmaceutical products. The MicroCurrent HVLD reduces voltage exposure to the product to less than 5% of the voltage exposure experienced when testing with comparable HVLD solutions. Reducing exposure voltage not only reduces any risk that the voltage poses to the product, but also greatly reduces the production of Ozone during operation when compared with traditional HVLD solutions. Ozone in the headspace of a container can be detrimental to the product, and in the operating environment can affect respiratory health.

Benefits:

Non-destructive Container Closure Integrity Test (CCIT)

Requires no sample preparation

Capability to test multiple packages in a single test cycle

Identifies which package is defective

Simplifies the inspection and validation process

Supports sustainable packaging initiatives

ASTM test method and FDA standard

Cost effective with rapid return on investment

Maintaining quality requirements and ensuring package integrity are important criteria for pharmaceutical product manufacturers. As such, the shift to more automated processes and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. In this blog, we will discuss automated package inspection techniques offered by PTI.

1. Vacuum Decay technology

Vacuum Decay technology is a non-destructive Container Closure Integrity Test (CCIT) used for leak detection in nonporous, rigid, or flexible packages. It is an ASTM-approved, FDA-recognized test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. This method involves drawing vacuum on the sample package kept in the test chamber and analyzing the vacuum level for any defect, indicating a leak.

Vacuum Decay technology is applicable across a wide range of pharmaceutical and medical devices with the capability of detecting leaks in single digit micron range while accommodating multiple packaging types. PTI has made further advancements in Vacuum Decay technology with its PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC technology that addresses vacuum decay detection at the very core of physical test measurement, controlling the test system volume and maximizing the SNR between good and defective samples. It is a a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results.

The VeriPac FLEX series, designed specifically for dry filled pouches and flexible packaging are available in several configurations with the ability to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. The VeriPac FLEX series offer defect detection to the 10 to 20 micron range.

2. MicroCurrent HVLD Technology

PTI's MicroCurrent HVLD technology is a unique High Voltage Leak Detection Technology for container closure integrity testing. It is found to be highly effective across a wide range of high-risk pharmaceutical products and medical devices. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. Being a non-invasive technique it requires no sample preparation and has a high degree of reproducibility and accuracy throughout.

The Microcurrent HVLD test method can detect the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects. It assures product CCI by scanning a non-conductive sealed container with electrode probes. Any defect in the packaging results in resistance differential and change in current flow in the container as well as the approximate defect location.

Such automated platforms would provide the same 100% testing capability with an accurate inspection that includes quantitative test data and a pass/fail result. Proper sensory measurement requires time to capture a result. However, these new automated technologies can still reliably inspect containers at a much higher rate than was possible before, with a more sensitive leak detection capability.

According to USP1207, the headspace inside a sterile pharmaceutical or medical device packaging is an important part of a product. Therefore, it should comply with corresponding quality-relevant attributes. The attributes may vary depending on the product. For instance, the residual oxygen concentration is one of the attributes for oxygen-sensitive formulations. Testing low headspace packages like sachets and blister packages can be quite challenging for manufacturers. Read on to know how PTI's VeriPac 410 ensures package integrity of low headspace packages.

Leak testing using VeriPac 410 series.

Over the years, manufacturers of multi-cavity blister packs and low headspace packaging have been using destructive test methods to evaluate the integrity of such packages. However, such traditional test methods lacked accuracy and produced subjective, and unreliable results. In order to overcome the limitations of destructive test methods, PTI has developed VeriPac 410 inspection system - a non-destructive seal and leak detection technology for blister packs, sachets, and pouches with low headspace.

The VeriPac 410 employs a mix of vacuum decay technology and differential force measurement to identify defects in packages. Multiple packages can be tested in a single test cycle, depending on package specifications. The non-deterministic nature of the test produces accurate and reliable results, removes subjectivity and the operators can get a definite pass/fail outcome. Additionally, being a non-destructive test method, the VeriPac 410 allows tested packages to be returned to the production line and eliminates the cost and waste associated with destructive leak test methods. This test method has a wide range of applications including low volume flexible and semi-flexible package leak testing.

Technology Overview

The VeriPac 410 tester is connected to a specially designed drawer-style test chamber. A custom package insert that conforms to the package shape increases test sensitivity. Certain types of packages can be tested in multiple during a single test cycle. The location of the defective package or cavity is identified. Vacuum levels are monitored during the test cycle to evaluate the package using the ASTM F2338 vacuum decay leak test method. Decay of the vacuum level indicates that air is leaking from the package into the test chamber.

Once the vacuum testing phase is complete, a pressure plate maps the surface pressure of the flexible package lidding. The pressure plate system recognizes the pressure pattern exerted by the package when it is not defective, and the lack of pressure exerted on the pressure plate by a defect, allowing for both defect detection and location of the defective package or cavity.

Benefits of VeriPac 410 system

Non-destructive, non-invasive, no sample preparation

Non-subjective, accurate and repeatable results

Capability to test multiple packages in a single test cycle

Identifies which package is defective

Simplifies the inspection and validation process

Supports sustainable packaging initiatives

ASTM test method and FDA standard

Cost effective with rapid return on investment

Packaging has always been an indispensable factor in the pharmaceutical manufacturing process. Since most pharmaceutical products come under high-risk category, appropriate packaging is vital to prevent product deterioration. Faulty or damaged packaging can cause oxygen, moisture, microorganisms or other harmful substances to enter the product- making it unfit for use. Given the sensitive nature of pharmaceutical products, package inspection testing holds high relevance. Let us now understand what CCI techniques are being offered by PTI for pharmaceutical package testing.

Techniques to ensure CCI

1. Vacuum Decay technology

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) method that is highly effective in detecting leaks in nonporous, rigid and flexible packages. It is a simple test method that challenges container integrity based on fundamental physical properties. As the name suggests, this test is conducted by drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). PTI has revolutionized Vacuum Decay technology with its s next generation of improvements in the form of PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC Technology is a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results. This method can be applied to flexible and semi-flexible packages alike.

The VeriPac FLEX series are innovative packaging inspection systems specifically for flexible packages. These are available in different configurations to accommodate various package specifications, capable of detecting leaks down to the 10 to 20 micron range.

Benefits of Vacuum Decay technology

Non-destructive, non-subjective, no sample preparation

Capable of detecting defects down to 0.05 ccm

Accurate, reliable, repeatable results

Supports sustainable packaging and zero waste initiatives

ASTM test method F2338

2. MicroCurrent HVLD Technology

High Voltage Leak Detection (HDLV) is a Container Closure Integrity test method that utilizes high voltage leak detector system for evaluating integrity of nonporous packages. The latest evolution in the HVLD technology, PTI’s MicroCurrent HVLD is revolutionary technology, a non-destructive, non-invasive CCI technique which can precisely detect any leak in a wide range of liquid filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

This method operates by scanning a sealed container using electrode probes to detect the presence of any leak. By analyzing a change in the current flow, the test operator can detect Defect in the container as well as its approximate location. PTI's MicroCurrent HVLD uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage compared to conventional HVLD technologies. This technology can be easily shifted from offline to 100% inline testing application, thereby simplifying the inspection and validation process.

Benefits of MicroCurrent HVLD technology

• Non-destructive, non-invasive, no sample preparation
• High level of repeatability and accuracy
• Effective across all parenteral products, including extremely low conductivity liquids (WFI)
• Low voltage exposure to the product and environment
• Listed in USP Chapter <1207> as recommended method for parenteral liquid package inspection
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats
• Simplifies the inspection and validation process
• Offline and 100% online inspection at high production speeds

Container closure integrity testing (CCIT) or leak testing is an important process in the manufacturing phase of a pharmaceutical drug product in particular parenteral products. CCIT is performed to evaluate and maintain sterility over the shelf life of a product as well as to prevent contamination of the product from moisture, reactive gases, or micro-organisms. In earlier times, dye ingress, microbiological ingress and other probabilistic test methods were being used in the industry. However, the results produced by such methods lacked accuracy, reliability and were highly subjective. Therefore, manufacturers are now replacing probabilistic test methods with deterministic methods, which reduce the needs for sample preparation and validation and provide more accurate detection of leaks and defects.

Why is VeriPac 465 effective in highly sensitive micro leak testing?

PTI's VeriPac 465 is a deterministic, quantitative inspection technology that is non-destructive and non-invasive to the package being tested. This technology requires no sample preparation and performs leak detection based on the basic principles of physics. The VeriPac 465 is an ASTM approved, FDA recognized package integrity testing method which is based on vacuum decay leak test method (F2338). This test method was developed using VeriPac leak test instruments. Unique test cycles, pneumatic controls and processing algorithms are certain features of VeriPac 465 system that make it the foremost vacuum-based leak test for parenteral products.

This inspection method is suitable for laboratory offline testing and QA/QC statistical process control. The test cycle takes only a few seconds, results are non-subjective and testing is non-destructive to both product and package.

 

Technology overview

The test begins by connecting VeriPac 465 leak tester to a chamber that is specially designed to contain the package to be tested. Vacuum is then applied to the test chamber in which the package is placed. Using dual transducer technology, the test chamber is monitored for both- level of vacuum and the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. VeriPac 465 technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. This technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats

Inspection Criteria

• Measures seal integrity of entire container or package
• Measures and verifies container closure system integrity
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, pre-filled syringes)

Benefits of VeriPac 465

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.002 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method and FDA standard

As pharmaceutical products leave the laboratory for distribution, they may be exposed to certain conditions that put their integrity at risk. Product quality deterioration and economic losses may be caused due to extreme temperatures or shocks during transportation. Pharmaceutical package inspection is vital to identify and control materials that may alter the protective capacities of packaging. Container Closure Integrity Testing of pharmaceuticals is performed with the purpose of guaranteeing the safety of the products during its distribution and storage lifecycle until delivery to the patient. CCIT helps in determining the integrity and stability of packaging or container until the point of delivery.

CCI testing using Vacuum decay technology

To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Although destructive Container Closure Integrity Testing (CCIT) methods like water bath, dye tests, peel and burst tests can detect leaks, they are time-consuming, unreliable and produce subjective test results. Additionally, they generate significant product loss and wastage. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.

Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)

How does Vacuum Decay Technology work?

Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.

Key Benefits of Vacuum Decay technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method
• FDA Recognized Consensus Standard
• Allows for increased sampling
• Quantitative results
• Repeatable
• Rapid test time
• Eliminates cost and waste of destructive testing
• Test results can be easily validated
• SPC laboratory testing or online applications

Medical device packaging plays a fundamental role in safeguarding the product and retaining its quality throughout its shelf life. A package containing medical devices should not only reach the hospital defect free, but it also must withstand sitting on a shelf, possibly for years, without breaking down. Therefore, medical device packaging should be in line with international regulations and quality standards. In order to ensure quality of medical device packages, manufacturers reply on package integrity and seal quality test methods. Although the market offers a complete range of inspection techniques, it is important for manufacturers to choose the appropriate one based on packaging material used and sensitivity levels required.

The ideal solution is a non-destructive method for inspecting the physical properties of the seal and a non-subjective analysis to determine the seal quality. PTI’s Airborne Ultrasound technology (ASTM Test Method F3004-13) uses a transmission of high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced.

Package inspection using Seal-Scan technology

PTI's Seal-Scan® is a non-destructive Airborne Ultrasonic technology (ABUS) that inspects and analyzes pouch seals offline. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis. This technology utilizes the ASTM Test Method F3004 for seal quality and integrity evaluation. .Seal-Scan® is a deterministic, quantitative, high-resolution method that inspects pouch seals for defects and seal integrity for consistency. Testing using a Seal-Scan® is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. PTI has designed several configurations of SEAL-SCAN® for both offline inspections to accommodate various package specifications, test sensitivity and package handling requirements.

Technology overview

Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results
• Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
• Produces high resolution Opto-Acoustic image of seal
• Characterizes overall quality and uniformity of the seal

Package integrity testing may be understood as a set of techniques used to protect the contents of a package from potential physical, chemical and microbial threats. It plays a crucial role in determining and maintaining sterility and shelf life of pharmaceutical products, medical devices, and food and nutrition products. Since such products are extremely sensitive to external environmental conditions, even a minute breach in the package can cause micro-organisms, reactive gases or other harmful substances to enter the product. This can result in serious health issues to the end user and affect brand loyalty of manufacturing companies. As such, testing for leaks is an important aspect of the manufacturing process.

Historically, manufacturers relied on destructive testing methods like Water Bath or Dye Ingress as well as other unreliable methods such as Visual Inspection to test integrity of packages. However, such tests lacked accuracy and reliability in test results. Moreover, being destructive testing methods, it caused damages to the package being tested making it unfit for use. These limitations of destructive techniques prompted manufacturers to opt for non-destructive testing methods that do not harm the product and provide reliable, repeatable and quantitative rest results. Reduction in waste coupled with material cost advantage gives non-destructive methods an practical edge over destructive test methods. Examples of non-destructive testing methods include Vacuum Decay technology, Airborne Ultrasound technology and Microcurrent HVLD technology.

VeriPac test systems for precise and reliable package integrity testing

PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing. These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

Technology Overview

PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute transducer technology is used to monitor the test chamber for both, the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or 100% inline testing.

Benefits of VeriPac series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard
• Referenced in USP 1207 guidance

Fresh coffee is the best coffee. The quality of coffee is directly linked to freshness, and maintaining freshness requires adequate packaging. In simple words, packaging is what holds coffee products and maintains its quality. However, maintaining freshness and shelf life of packaged coffee is often a challenge for manufacturers. The flavors and oils in coffee are oxygen sensitive, while flavor profile being the key differentiator for consumers. External conditions like high temperature, light, or high humidity can increase the rate of staling. Under such conditions, whole beans will lose significant amounts of flavor and develop stale fragrance in 1-2 weeks, while in case of ground coffee the process takes 1-2 days. Compromised package integrity can result in oxidation, flavor degradation, and spoilage. Leaks as small as 10 microns can draw oxygen into the package over its shelf life. If a consumer encounters a product that exhibits oxidation, the bitterness and stale flavor will likely affect the consumer’s decision to repurchase. This explains why manufacturers give prime importance to evaluating integrity of coffee packaging.

Conventionally, water bath was the most popular technique for leak testing coffee products. Although water bath is a simple and effective leak testing method for rigid containers, it fails to meet critical needs associated with flexible coffee packages. Additionally, the cost associated with maintaining standard destructive methods is high. Subjective test results, variable test standards, and higher risks associated with the use of other methods emphasize the need for better alternatives. Hence manufacturers today opt for non-destructive testing methods that eliminate the cost associated with wasted product, and ultimately facilitate better quality control.

Package integrity testing using Vacuum Decay technology

PTI’s Vacuum Decay technology is an ASTM-approved, FDA recognized non-destructive Container Closure Integrity test method with proven capabilities to provide reliable, reproducible, repeatable and accurate quantitative results. It can detect oxygen critical leaks, providing a more reliable and sensitive solution for a range of packaging formats that is designed to protect oxygen sensitive products. This method involves drawing vacuum on the sample package kept in the test chamber, and analyzing the vacuum level for any defect-indicating a leak. VeriPac systems reliably detect leaks as small as 10 microns, identifying process issues before they become critical, avoiding costly quality deviations.

For coffee sachets, stick packs or pouches, PTI’s VeriPac FLEX series offer the highest level test sensitivity, detecting micro leaks into the single digit micron range. These are versatile non-destructive package inspection systems designed specifically for flexible packages. To accommodate various package specifications, the VeriPac FLEX is available in several configurations. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics. Hence, VeriPac vacuum decay is a practical alternative and significant improvement to the destructive test methods commonly used for flexible packaging.

Benefits of Vacuum Decay technology:

• Reliable and sensitive leak detection of quality critical defects
• Cost savings
• Using a non-destructive leak test method allows an increase in the number of product samples tested
• Rapid test cycle and minimal training required to operate tester
• Rapid ROI due to substantial cost savings and elimination of product loss

What is VeriCon Technology?

VeriCon system encompasses a complete line of leak testers for empty bottles and containers. It is a powerful leak detection system that operates round-the-clock to ensure high leak test sensitivity with the capability to measure down to 200 microns. Under this process, the container is filled with pressure to a certain level. The rate of pressure decay is analyzed and measured which corresponds to pressure within the container. The operating panel displays pass/fail results and the defective container is rejected from the line . With PTI’s VeriCon technology, users can choose from a wide range of leak tester configurations, according to different container specifications. Its applications include plastic, blow molding, food, beverage and pharmaceutical industries. VeriCon technology works well for small, medium to large size containers and has inspection rates upto150 bottles/min. range. According to Heinz Wolf, general manager, Packaging Technologies and Inspection “In addition to the basic inspection economics of identifying leaking containers and minimizing false rejects, VeriCon systems offer many additional advantages that increase overall operational efficiency. The Auto-learn feature for example, automates setup of accept/reject criteria. Real time inspection data with reject statistics and test result With reject statistics & test result trends, VeriCon technology ensures on demand analyses of container quality.”

VeriCon technology can be implemented using pressure decay or vacuum decay technology. Plastic containers of almost all sizes use pressure decay technology. In situations where due to specific characteristics of the container, pressure decay technology is not capable of detecting leaks, Vacuum decay technology is applicable. Depending on the line speed/hole size requirement, VeriCon testers are available in one to four station configurations.

VeriCon Configurations

• Trimmer mount: available in single and dual station configurations, VeriCon trimmer mount systems are designed precisely for indexing systems installations.
• Linear Leak Testers: available in single or multi-station configurations for standard online linear leak detection with inspection speeds up to 70 bottles/min.
• Continuous Motion Testers : available in 1 to 4 station configurations with inspection speeds up to 150 bottles/min. Continuous motion inspection’s high speed testing ensures uninterrupted inspection of containers.

Benefits of VeriCon technology:

All VeriCon systems offer the following features and benefits:

• VeriCon technology uses high-resolution non-drifting transducers thereby ensuring consistent leak detection.
• Accurate leak testing with repeatable results
• 24/7 operation
• Capable of accommodating multiple container specifications and test sensitivity requirement

Ensuring packaging quality is pivotal in all manufacturing. For efficient packaging, it is important for manufacturers to have complete knowledge of packaging material used and test sensitivity desired, so that appropriate package integrity tests can be undertaken.

Today’s healthcare industry assures treatments that were unimaginable a few years ago. As pharmaceutical industry grows in importance, the techniques of primary packaging for healthcare products, especially parenteral products has taken on new prominence. Common parenteral packaging methods include Liquid-filled containers such as vials, ampoules, syringes, blow-fill-seals and auto-injectors and containers filled with lyophilized products. Since these drugs are directly administered into human bodies, high sensitivity integrity tests are required to ensure product quality throughout its shelf life. For reasons of safety, packaging material, integrity and design are regulated by Food And Drug Administration as strictly as the product itself.

Container Closure Integrity Testing is a leak detection test conducted using a non-destructive packaging inspection system to protect the drug from any possible contamination. It is a crucial step in evaluating safety and integrity of the primary packaging so as to maintain a sterile barrier and to avoid leakage resulting in contamination of the drug. Packaging components like bottles, vials, syringes that are in direct contact with the product are called primary components while aluminum caps, cardboard boxes are secondary components as they are not in direct contact with the product. Proper packaging should be a priority for all drug products, but in case of parenteral products, these concerns amplifies several folds as they are directly injected. Hence initiating a proper container closure system is vital for product and consumer safety.

Although Container Closure Integrity Testing(CCIT) can be performed in many different ways, it can be broadly classified into Probabilistic methods and Deterministic methods. Probabilistic test methods including Microbial Challenge by Immersion, Tracer Liquid Tests (e.g. Dye Ingress), Bubble Tests etc. are traditional test methods where result accuracy may be uncertain. On the other hand, Deterministic test methods like Electrical Conductivity and Capacitance Test (HVLD), Laser-based Gas Headspace Analysis, Mass Extraction, Pressure Decay provide quantitative results with high accuracy. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test methods.Packaging Technologies And Inspection (PTI’s) Microcurrent HVLD technology and vacuum decay technology are the latest inventions in package integrity testing of parenteral products.

1. Microcurrent HVLD Technology: Microcurrent HVLD is a unique High Voltage Leak Detection Technology, highly effective across all parenteral products. Its Applications include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to proteinaceous products with suspensions. Its ability to detect small pinholes, micro cracks and seal defect detection down to single-digit microns makes it an ideal choice for testing parenteral products.

2. VeriPac Vacuum Decay Technology: VeriPac Vacuum Decay Technology, based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing, is a non-destructive inspection system, capable of defect detection down to 0.002 cc/min. This system is applicable for empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. Depending on the package type and leak test sensitivity needed, appropriate VeriPac model can be selected.

PTI’s next generation PERMA- VAC technology addresses vacuum decay detection at the very core of physical test measurement by controlling the test system volume and maximizing the SNR between good and defective samples. This makes PERMA-VAC the most reliable vacuum-based leak test available in the market.

The global pharmaceutical industry has seen tremendous growth over the last few decades. The complex nature of the industry coupled with frequent breakthroughs has made it a favorite subject of scrutiny. Since any defect in the packaging of drugs can have serious consequences, assuring the quality of the packaging is of prime interest for every manufacturer. Pharmaceutical products are expected to be free from microbial contamination and safe to use right from production throughout their shelf-life. The drug’s stability can be adversely affected through contamination in the form of oxygen, humidity or microbiological ingress. In order to prevent such risks, integrity tests with high sensitivity are required.

Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasised the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI). FDA defines Container Closure Integrity Testing (CCIT) “as the sum of packaging components that together contain and protect the dosage form”.

Container Closure Integrity Testing is a method of leak detection using a non-destructive packaging inspection system to prevent possible contamination. Such a test is essential since any defect in the container can cause external particles to enter the product, thereby reducing its shelf life. Implementing right Container Closure System has been of prime importance for a manufacturer as it affects both the product and the patient. Hence, the relevance of CCI Testing in the pharmaceutical industry has steadily increased over the years. Contaminants that can enter a product include micro-organisms, reactive gases, and other substances. CCIT ensures product quality is maintained from the point of manufacture throughout its distribution and use. Container closure systems include primary packaging components and secondary packaging components. Components such as a glass vial or syringe, which come into direct contact with the product, are primary packaging components. On the other hand, components that are crucial to ensure correct package assembly, such as aluminum caps, over stoppers etc. are the secondary packaging components

CCI Testing Methods

Container closure integrity testing can be performed in many different ways. Each method has its own merits and demerits. A number of factors have to be considered while selecting appropriate testing methods. These factors include, but are not limited to; the reliability of the test method, material of the primary package and inline versus an offline testing requirement. CCI testing methods can also be selected depending on specific desired outcomes. Examples of desired outcome include: identifying the presence of leak paths, understanding leak path’s location, evaluating leak rate for the whole package, and measuring potential for microbial ingress. The United States pharmacopeia released guidance in 2016 stating that deterministic methods are preferred over probabilistic test method.

1. Probabilistic methods: Here, the testing methods are more traditional, and the accuracy of the result is uncertain. The probabilistic methods include the following:

• Microbial Challenge by Immersion
• Tracer Liquid Tests (e.g. Dye Ingress)
• Bubble Tests
• Tracer Gas (Sniffer Mode)

2. Deterministic methods: Such methods provide quantitative results with a higher level of accuracy. The chances of errors are also minimal. The deterministic methods include the following:

• Electrical Conductivity and Capacitance Test (HVLD)
• Laser-based Gas Headspace Analysis
• Mass Extraction
• Pressure Decay
• Tracer Gas (vacuum mode)
• Vacuum Decay