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Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them

● Quality Control  ● Regulatory/Clinical Affairs  ● Research/Development/Design   Manufacturing

This presentation will provide a brief overview of the types of tests that are available to validate a sterile barrier system. While performing these tests, though not expected, failures can happen. The presentation will also look at common failures within these tests and provide understanding of their causes.

Session Takeaways:
• Packaging attributes and validation testing
• Discovering the root cause of a failure identified during package validation testing
• Tools to assist in determining the appropriate tests for validation

WendyMachWEBWendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader
Nelson Laboratories

Since 2004, Wendy Mach has overseen the integrity, strength and microbial barrier tests in Nelson Laboratories’ packaging department. After 17 years of testing medical devices, Ms. Mach is an expert in packaging validations, sterilization validations and microbiology testing. Before joining Nelson Labs, she worked as a lab supervisor for testing of sterility, microbial limits, bioburden, limulus amebocyte lysate and antimicrobial effectiveness. She began her career as a microbiologist performing in-house verification and validation.

Ms. Mach is the technical contact for ASTM F1608 on the F02 committee for flexible barrier packaging of the American Society for Testing and Materials (ASTM) and is a member of the Association for the Advancement of Medical Instrumentation (AAMI) packaging work group. She graduated with a B.S. in biology from the University of Minnesota.