Practical Implication and Decision Making of PUPSIT

This final installation of the Science, Implementation, and Implications of PUPSIT in Terminal Sterilizing Filtration webinar series will build on information presented in the first two webinars. This webinar will help you develop a strategy for the use of scientific data and Quality Risk Management (QRM) principles to answer the questions: (1) What are the risks associated with sterile filtration of your products? (2) What controls are needed to mitigate those risks? (3) Is a pre-use post-sterilization integrity test (PUPSIT) an effective strategy to control the process and mitigate those risks? (3) If so, what is the best way to implement it? (4) If not, then what is a sound justification for that decision? These are questions that have been challenging operations and their filtration experts since the inclusion of PUSPIT in Annex 1. Finding the correct answers has become increasingly significant with the ongoing debate about the wording and interpretation in the current Annex 1 redraft. In this webinar the PDA and BioPhorum SFQRM consortium will present and moderate a discussion on how to make informed decisions on how best to control and prevent sterilizing grade filter failures or improve detection of failures.

This will be a 90-minute webinar to ensure ample time for questions.

Learn more about the three-part webinar series, The Science, Implementation, and Implications of PUPSIT in Terminal Sterilizing Filtration.