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For final package performance testing could you submit packages produced at the nominal process parameters if the process has been validated? If the process has not been validated then packages for final package performance testing must be produced at worst case process limits?
Last Updated On May 15, 2008
To address the first question, if the sample size was appropriate to ensure that the range of package characteristics was represented (ideally from multiple lots) then packages produced at the nominal process parameters could be used for final package performance testing. Often the medical device manufacturer chooses to make the final closure seal at the specified process limits of sealing.
As for the second question, the process must be validated in order to meet ISO 11607. That is the only way to establish the worst-case process limits. However, packages can be produced at the worst-case validated process limits to create sterile barrier systems for final package performance testing. This approach can be quite costly because it requires specific and separate production runs.