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Test Method Validation

"Requirements for Test Method Validation"

Most medical device manufacturers perform in-process and/or final inspection of sterile barrier packaging seals. Do the requirements for test method validation (reproducibility, repeatability, sensitivity, etc.) apply only to test methods used to validate sterile barrier packaging, or do they also apply to tests performed as part of in-process and final inspection during routine production?

Last Updated On January 7, 2009

All test methods which are used to obtain data that supports sterile barrier system conformance to ISO 11607 must be validated. Conformance to ISO 11607 includes ISO 11607-2, Validation requirements for forming, sealing, and assembly processes. As “routine production” would be in accordance with the validated processes, the tests performed during in process and final inspection during routine production would most likely have been performed or specified during the validation as well. Therefore, they should be validated.