Product & Packaging Testing

Ensuring that a medical device and its packaging are safe and perform effectively is crucial when guiding product development, regulatory compliance, and marketing efforts. Nate Wilhelm, Packaging Testing Manager at STERIS Applied Sterilization Technologies (AST), outlines essential tests for validating sterility of a medical device’s packaging and explains when to use each test. Then, Phillip Roxby, Technical Services Manager at STERIS AST, discusses a variety of tests for assessment of medical devices.

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Product & Packaging Testing to Support Medical Devices Overview

 Sterile Packaging Testing

1:23 – Why Test?

2:51 – Which Test Method?

7:48 – Distribution Testing

9:08 – Stability & Aging

11:39 – Strength & Integrity

13:28 – Bubble Leak

14:00 – Dye Penetration

14:21 – Peel Testing

Medical Device Testing

17:31 – Test Method Validation (TMV)

22:19 – Device Testing Example

26:16 – Catheter Balloon Burst Test

26:44 – Force to Deploy

27:44 – Luer Connector Compliance

28:32 – Biocompatibility