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For conditioning methods (such as ISTA methods), doesn't one need to validate that it is somehow representative of the distribution environment your package will see?
Last Updated On May 15, 2008
First, it is important to understand that the ISTA methods are conditioning methods or protocols rather than test methods. As such, there is no ISO 11607 requirement that they be validated but rather a rationale must be developed that demonstrates the applicability and appropriateness of the protocol. You need to understand the distribution environment that your packages will likely see. This is important in setting up the distribution testing of finished packages required by ISO 11607. If you understand the distribution environment and can find a conditioning method or protocol that closely simulates that environment then you could rationalize using that method as part of the distribution testing. If the distribution environment is not well understood then it is necessary to do actual shipping tests to complete the distribution testing requirement, or, with appropriate rationale, use published data that provides information about storage and distribution environments that have been measured.