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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.

In the medical device industry, appropriate packaging is meant to ensure product protection and integrity throughout the entire supply chain. Medical device packaging requirements are very strict and should adhere to health and safety regulations across borders, signifying the relevance of packaging validation standards. Faulty packaging can cause various problems for medical device companies as well as patients. A package containing a sterile medical device should not only reach the doctor or medical facility damage free, but it should also be able to maintain its quality and sterility until used. Hence seal integrity testing of medical device packages is critical.

Seal integrity testing is a crucial element to ensure quality of packaged sterile products. A compromised seal can initiate a leak, destroying the protective atmosphere of products and reducing its shelf life. It can also lead to massive product recalls, causing huge monetary loss and tarnished brand reputation. Hence, applying the right seal integrity testing system is vital to ensure that the packages are properly sealed to avoid potential contamination and breach in sterility.

Although there are multiple methods to conduct a seal integrity test, it can be broadly classified into destructive testing methods and non-destructive testing methods. Under destructive testing method, the package may get destroyed and cannot be returned to the market after testing. On the other hand, non-destructive test methods do not cause any harm to the packages resulting in material cost advantage and reduced waste. “There is a huge shift in the industry towards deterministic and quantitative test methods,” comments Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Seal integrity testing using Airborne Ultrasound technology

PTI’s Airborne Ultrasound technology is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. It is a non-destructive seal quality inspection method for effective seal quality testing and analysis. With the capability of non-destructive and non-invasive seal quality inspection, Airborne Ultrasound technology is a optimal choice for testing integrity of pouches, flexible packages and tray seals.

This method operates by propagating ultrasound waves through the package seal as they move along the sensor head, causing reflections of sound waves. In the presence of a leak, the seal strength is either reduced or eliminated. Signal strength variations are closely monitored to detect defects. The ability of Airborne Ultrasound technology to identify several types of seal defects; visible and invisible, leaking, and non-leaking, process-related and random makes it a practical choice for seal quality inspection in the medical device industry.

Benefits of Airborne Ultrasound technology

• Non-destructive seal quality inspection technique with quantitative test results.
• Eliminates subjective manual inspection methods.
• Cost effective
• Non-destructive, non-subjective, no sample preparation
• Supports multiple packaging materials including Tyvek®, paper, foil, film, aluminum, plastic & poly
• ASTM Test Method F3004, FDA Recognized Standard and referenced in USP 1207 Guidelines.