Cover-3PUPSIT: Consideration in Implementation

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.