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Sample Size & Medical Device Package Testing

  • Broadcast in Business
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Determining an appropriate sample size for medical device package testing is an essential consideration for anyone pursuing the validation of a sterile barrier system. The question of “how many should I test” is one of the top questions medical device packaging engineers pose or consider when developing a sterile barrier system test plan.  Unfortunately, the regulatory guidance that exists around the issue of sterile barrier system sample size is not definitive or prescriptive in nature. 

This radio show will cover the following:

  • Compliance and Guidance Documents for Sterile Barrier Systems
  • Determining Sample Size for Final Packaging System Validation
  • Tips for Developing an Appropriate and Statistical Valid Test Population for SBS Validation
  • A question and answer period with the guest speaker


Speaker: Karen K. Greene, CPP

Karen Greene, CPP, is currently Vice President, Life Packaging Technology LLC. She is a certified packaging professional, the Co-President of the Southern California Chapter of the Institute of Packaging Professionals, and a committee chairperson of the IoPP Medical Device Packaging Technical Committee. She is a member of the ASTM F02, Flexible Barrier Packaging committee, and an ISTA 7E (thermal design and validation) certified auditor. Ms. Greene is a lead industry consultant for medical device and pharmaceutical package development, validation, and production implementation projects and has solved problems related to sterile barrier package integrity, package design, test method development, and test method validation and packaging quality related issues.