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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