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The World Health Organization (WHO) has stated that healthcare associated infections pose the highest risk in the delivery of healthcare services globally. This causes a serious threat to millions of patients worldwide every year. Therefore, ensuring sterility of medical devices is an important way to reduce the risk associated with faulty medical devices in hospitals and other healthcare settings.

Appropriate packaging and packaging materials are crucial to help preserve sterility of medical devices. Conventionally, medical device manufacturers relied on manual visual inspection as a method for assuring quality. However, such methods lacked accuracy and reliability in test results. To overcome the limitations of traditional test methods, manufacturers moved towards deterministic Container Closure Integrity testing (CCIT) methods that ensured quantitative and accurate test results.

PTI’s Airborne Ultrasound technology is a seal quality inspection test method, capable of non-destructively examining seal quality for defects. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing. Such tests are mainly conducted to provide enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analyses and is applicable for multiple packaging materials Tyvek, paper, foil, film, aluminium, plastic and poly. According to Oliver Stauffer, CEO of PTI-Packaging Technologies & Inspection, “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are.”

Under this technology, ultrasound waves are passed through the package seal which causes reflections of sound waves. The signal strength is reduced or eliminated in the presence of a leak/ defect. Such variations are closely observed to identify the leak. Inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne Ultrasound technology, users are able to identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. With the advancements in form of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing, in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

Benefits of Airborne Ultrasound technology:

• Deterministic seal quality inspection technique that assures quantitative and reliable results.
• Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
• Eliminates subjective manual inspection methods.
• Non-destructive, non-subjective, no sample preparation
• Technology can be integrated for 100% online defect detection of the final pouch seal.