PDA Journal: Test Process and Results of Potential Masking of Sterilizing Grade Filters

The objective of the SFQRM Consortium Masking Studies workstream was to determine if the hypothesized masking phenomena can occur, and if so, under what conditions. The benefit of this information would be to provide industry with criteria for predicting and preventing flaw masking.

With this study the team examined if extremely high foulant concentration fluid and blockage rate, well beyond commercially feasible conditions, can mask the filter flaw that the post-use integrity test does not detect it.

This deliverable has been published via the PDA website.

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