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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.

Pouch packaging is a widely utilized solution across industries, including pharmaceutical, medical device, and food sectors, due to its convenience, versatility, and cost-effectiveness. However, the integrity of seals in pouch packaging is a critical parameter that directly impacts product quality, safety, and shelf life. Ensuring seal integrity requires advanced testing methods capable of detecting even the smallest defects, such as pinholes or weak seals. Among these methods, Airborne Ultrasound Technology has emerged as a highly effective solution.

What is Seal Integrity Testing?

Seal integrity testing is a non-destructive testing method used to verify the quality and strength of seals in packaging. It involves assessing the packaging's ability to maintain a hermetic barrier, ensuring no leakage, contamination, or compromise to the product within.

Seal integrity tests evaluate factors such as:

• Presence of pinholes or microcracks.
• Uniformity of the seal.
• Ability to withstand environmental stresses like pressure and temperature changes.

Why is Seal Integrity Testing Important Across Key Industries?

Pharmaceutical Industry

In the pharmaceutical sector, pouch packaging is used to contain sensitive drugs, powders, and diagnostic kits. Seal defects in this industry can lead to contamination, loss of efficacy, and regulatory non-compliance. Ensuring seal integrity is vital for maintaining sterility and adhering to stringent quality standards like cGMP.

Medical Device Industry

Medical devices often require sterile barriers for implantable devices and products to ensure patient safety. Defective seals can compromise sterility, risking infections or device malfunction. Seal integrity testing helps manufacturers meet ISO 11607 and other regulatory standards.

Food Industry

In the food industry, defective seals can result in spoilage, contamination, and reduced shelf life. For perishable items, maintaining airtight seals is essential to prevent the growth of pathogens and ensure product safety.

Seal Integrity Testing Using Airborne Ultrasound Technology

PTI has revolutionized seal integrity testing with Seal Scan (Offline) and Seal-Sensor, both of which utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing, whether in offline laboratory testing for seal quality analysis or 100% inline testing on the production line.

Seal integrity is a cornerstone of quality assurance in pouch packaging. Its significance spans industries like pharmaceuticals, medical devices, and food, where product safety and compliance are non-negotiable. Airborne Ultrasound Technology is setting new benchmarks in seal integrity testing by offering non-destructive, precise, and efficient solutions.

By integrating this advanced testing method, manufacturers can not only enhance the reliability of their packaging but also strengthen consumer trust and regulatory compliance. Embracing innovative technologies like Airborne Ultrasound is a step forward in ensuring the highest standards of product quality.

Sealer validation is integral to ensuring the reliability of medical device packaging, yet it is often perceived as complex and time-consuming. This process involves extensive parameter development, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Adding post-validation process verification further increases the complexity, as well as the need for long-term reliability. Each stage of sealer validation and verification comes with unique challenges that demand complementary and precise test methods to assess the quality of sealed packages.

Why Seal Quality Matters?

Seal quality is critical for ensuring the safety and efficacy of medical devices. Traditional inspection methods often fail to address the combined importance of seal consistency, strength, and integrity, creating potential quality gaps.

Heat-sealed packages for sterile or sensitive contents must meet stringent standards to maintain sterility and prevent contamination. Advanced inspection methods like vacuum decay or helium leak detection help ensure seal reliability and regulatory compliance. High-quality seals are essential for patient safety and maintaining product performance throughout its lifecycle.

Leveraging Deterministic and Non-Destructive Testing Technologies

A common misconception about adopting advanced technologies like deterministic and non-destructive testing (NDT) is that they involve significant costs and operational complexities. In reality, these technologies—particularly airborne ultrasound—offer a streamlined, cost-effective solution for validating heat seals without compromising on quality or efficiency.

Airborne ultrasound technology provides accurate, non-destructive inspection of sealed packages, enabling the detection of defects such as channel leaks, weak seals, or inclusions. By offering deterministic results, this method eliminates subjective interpretations and enhances confidence in the seal quality.

The Advantages of Outsourcing and Flexible Solutions

Outsourcing seal quality testing or temporarily acquiring the necessary equipment can significantly reduce the financial and operational burden of sealer validation. PTI’s Seal Quality Assurance Program delivers tailored services designed to meet both short-term and long-term needs, offering flexibility and scalability. This approach allows organizations to:

• Expedite the sealer validation process.
• Ensure compliance with regulatory requirements.
• Enhance the overall reliability of heat-sealed packaging.
• Minimize capital expenditures by utilizing outsourced expertise.

Airborne Ultrasound Inspection: A Game-Changer for Sealer Validation

PTI’s Seal Quality Assurance Program leverages the power of airborne ultrasound inspection to address the most complex challenges in sealer validation. Whether you require a one-time project solution or an ongoing testing partnership, our services provide high-quality results that align with the evolving demands of medical device packaging.

Through advanced inspection methods, we help organizations achieve unmatched quality, consistency, and reliability in their sealing processes. With a focus on flexibility and precision, PTI’s services are the cornerstone of modern sealer validation.

Airborne ultrasound inspection revolutionizes sealer validation by ensuring precision, compliance, and reliability in medical device packaging. PTI’s flexible solutions empower organizations to achieve superior seal quality with efficiency and confidence.