Pre Use Post Sterilization Integrity Testing - Considerations In Implementation

By Jeff J. Gaerke, P.E., Principal Consultant

There has been significant debate over the years between regulatory agencies and the pharmaceutical industry regarding the advantages and disadvantages related to patient sterility risk with performing Pre-Use Post-Sterilization Integrity Testing (PUPSIT) of sterilizing-grade filters. This white paper will not add to this specific discussion; instead, the purpose of this document is to provide the reader with items to consider when determining how to implement PUPSIT in a robust manner for their particular application in instances where the decision is to perform PUPSIT.