Whitepaper: Application of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

Application of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)

The latest revision of EU GMP Annex 1: Manufacture of Sterile Medicinal Products (August 2023) included PUPSIT meaning that for biopharmaceutical manufacturers who use filtration to sterilize their final products, PUPSIT is now a default requirement. This white paper discusses the considerations and challenges for the incorporation of PUPSIT into both single use and hard piped processes including filter selection and integrity test method, and system design, location and operation.

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