technology

PUPSIT integrity testing

Pre-Use Post-Sterilization Integrity Testing of a sterilizing-grade filter, an EU GMP Annex 1 expectation increasingly delivered as a dedicated automated skid rather than a manual bubble-point procedure.

Where it's used

Sterilizing-grade filters
0.2-micron-rated membrane filters, cartridges and syringe filters that remove bioburden from process fluids, buffers and final drug product before fill-finish — a distinct hardware/consumables category from resin-based chromatography, sold by four specialist manufacturers (Sartorius, Cobetter, Meissner Filtration Products, Parker Bioscience Filtration) spanning syringe-scale lab filters through single-use process-scale assemblies.
consumables 7 min