PTI exhibited at the PACK OUT conference in Austin, TX, May 9-11. Rob Zecchin, National Sales Manager, gave a presentation on Tuesday, May 9 which was well attended on the topic of
Shifting the Integrity Testing Paradigm for Medical Device Packaging
Looking forward to next year’s PACKOUT event!
Inspection Technologies for Seal Quality and Integrity Testing – How to shift away from probabilistic methods to non-destructive testing solutions for medical device packaging
New technology innovations have allowed for numerous advances in Closed Container Integrity (CCIT) and seal quality inspection. These innovations not only increase sustainability with the introduction of non-destructive testing methods but increase patient safety with deterministic and quantitative methods. These methods can be simply defined and acted upon with a variety of physics-based technologies. With the introduction of these techniques, we will continue to evaluate the differences between probabilistic and deterministic methods and associated technologies such as Dye ingress, Bubble emission, Vacuum decay, and Force decay.
Vacuum decay, Airbourne Ultrasound, and Force Decay have stood at the forefront of deterministic, quantitative and non-destructive test methods for the medical device industry. Each of these methods not only fulfills current regulatory requirements but allows for shared validations, scalability and increased testing frequency.
Further diving into these non-destructive test methods, this presentation will discuss full scale implementation and validation of Force decay technology inspecting packaged medical devices. We will focus on how to shift away from probabilistic methods and easily validate these non-destructive technologies with the use of positive controls and statistics.