The seminar provides a comprehensive understanding of the regulatory requirements and practical challenges related to Pre-Use Post-Sterilization Integrity Testing (PUPSIT). The focus is on Annex 1 of the EU-GMP guidelines as well as the expectations of authorities and auditors. Participants will learn to correctly interpret regulatory guidelines, make risk-based decisions, and develop appropriate implementation strategies.

PUPSIT is technically, spatially, and organizationally demanding, especially with existing facilities. While some manufacturers have already implemented PUPSIT, others require thorough risk analyses to justify alternatives or the omission of this step. Annex 1 (2023) intensifies the expectations: PUPSIT is generally required unless a scientifically supported risk assessment indicates otherwise.

As an important quality assurance measure, PUPSIT confirms the integrity of the sterilized filter before use, thereby minimizing contamination risks. However, practical implementation often requires system adjustments, investments, additional space, as well as revised SOPs and training. The seminar discusses regulatory guidelines, typical implementation issues, and offers a risk-based methodology for deciding “PUPSIT – yes or no?”