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"Application of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) in BioPharm Final Fill"

Annex 1 Requirements for PUPSIT System Design and Operation in Biopharmaceutical Final Final Processes

In August 2023, the latest revision of the EU GMP Annex 1 became operative throughout Europe. For manufacturers who cannot terminally sterilize their product in its final container and need sterile filtration, the revised Annex 1 means that Pre-Use Post-Sterilization Integrity Testing (PUPSIT) has become a default requirement.

This white paper discusses the drivers and considerations for the implementation of PUPSIT, and makes recommendations for successful sterile system design, examining both hard-piped and single-use systems. 

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