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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.