The Role of the Pre-use Post-sterilization Integrity Test (PUPSIT)... - 24 de julio de 2024 - TecnoWebinars.com

Full title: The role of the pre-use post-sterilization integrity test (PUPSIT) in a contamination control strategy. The recent revision of EU GMP Annex 1 positions the need for a pre-use post-sterilization integrity test (PUPSIT) in the context of Quality Risk Management and highlights that this is a natural component of the contamination control strategy (CCS). In this webinar, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle. We review the risk assessment process as a precursor to developing an effective CCS and provide guidance on PUPSIT and other filtration-related contributions to the strategy. Throughout the webinar, we will share the perspectives from Cytiva’s experienced scientific and application teams and guidance for its successful implementation. A medical laboratory from Spain, Reig Jofre, will also share their industry standpoint and showcase their journey of PUPSIT adoption and compliance, using both manual and automated solutions.