In Situ Leak Testing, Integrity Testing, And PUPSIT For Flow Kits Using The Manual Drug Product Filtration System

Final drug product filtration is a critical safeguard in sterile drug manufacturing, ensuring patient safety by removing contaminants before filling vials or syringes. To strengthen contamination control, updated EU GMP Annex 1 guidelines recommend pre-use post-sterilization integrity testing (PUPSIT) for sterilizing-grade filters. Implementing PUPSIT helps verify filter integrity after sterilization, reducing risks from damage during handling or installation. A manual filtration system configured for single or redundant filter arrangements enables in situ leak testing, filter wetting, and both pre- and post-use integrity checks. These steps confirm a closed, sterile flow path and minimize contamination risk throughout the process. Performance data from typical applications demonstrate reliability across multiple filter sizes and membrane types commonly used for sterile drug filtration.

Explore how robust filtration practices and integrity testing can enhance compliance and product safety.