In Reply to Parent Post by Biobry
Another question though along those lines, what is your acceptance for the package integrity testing (we use dye penetration). Do you accept any failures or is 1 failure enough to fail validation.
The extensive list of ASTM standards "methods" listed in ISO11607 Appendix B often contain guidance on acceptance criteria. Obviously if your packaging is also your sterile barrier system your acceptance range is going to change quite markedly.
<sanctimonious sermon warning>
IMHO you should never detect a sterile packaging seal failure using routine testing (failure should be gross failure), and if you do, you have to look at reprocessing the batch as the implications of loss of sterility are too great (packaging also has to support the SAL of 10 x-6
, so one failure in a million maximum).
If you are testing to destruction then you need to set your acceptance based on realistic handling conditions, and try to ensure that "damaged" packaging is self-evident in its failure mode (11607: 5.1.10) that way there is no risk of your customer receiving and using an breached package in error.