Sterile filtration QRM & Pupsit​

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PUPSIT: identifying risks and preventive controls

PUPSIT: identifying risks and preventive controls

Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while it is recommended by regulatory bodies, it may compromise downstream sterility and it is expensive to mitigate these risks. ...