PUPSIT Simulation as part of Process-Specific Bacterial Retention Testing (PUPSIT-BCT): Poster Presented at PDA Week...

Pre-Use Post Sterilization Integrity Testing is implemented in sterile filtration applications by drug manufacturers using a risk-based approach with consideration of the stipulation in Eudralex volume 4, Annex 1, of the European Union Good Manufacturing Practice for Sterile Products. During process-specific bacterial retention testing, required as part of sterile filter validation, it is important to simulate the filtration process under evaluation as closely as possible. Worst-case conditions experienced by the process filter during routine use that may impact the process filters' ability to produce a sterile effluent must be accounted for. Given these two facts, do PUPSIT conditions need to be considered during process-specific bacterial retention testing? And if so, how should they be simulated?Performing pre-use post sterilization integrity testing introduces additional mechanical stress on the process filter and a potential new route for the introduction of bioburden into the process fluid flow path related to the filter wetting procedure. We would like to present a risk-based bacterial retention test design that incorporates a pre-use post sterilization integrity testing simulation phase, after a thorough evaluation of the process specific conditions, to rule out impact on efficacy of the sterile filtration process.