Pre-use/post-sterilization integrity testing of sterilizing filter

The topic of pre-use/post-sterilization integrity testing of sterilizing grade filters has become a hot button due to misinterpretation of EU Annex I, paragraph 113 and sporadic, unnecessary enforcement of such test. The test should be applied only after risk assessment, as the manipulation of the sterile downstream side due to the applied integrity test after sterilization can elevate the risk of the filtrate side. Risk assessment by the filter users is the right choice, not generic enforcement.
Check for two papers on the topic in American Pharmaceutical Review and Pharma.