The Sterilization Packaging Manufacturers Council of the Flexible Packaging Association has been addressing questions about test method validation and other issues pertaining to sterile barrier systems after speaking in the 2008 PMP News Webcast, “Understanding the Nuances of ISO 11607.” To view the archived Webcast, visit www.devicelink.com/pmpn/iso11607 .
A recent question posed to the group inquired about how far test method validation should extend:
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?
All test methods that are used to obtain data that support 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.