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. To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on...

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How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation 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 some regulatory bodies are asserting its need, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry...

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PUPSIT – An update on BioPhorum/PDA work to develop a risk-based position

PUPSIT – An update on BioPhorum/PDA work to develop a risk-based position

Do you need to commit to a pre-use post-sterilization integrity test (PUPSIT) strategy? Is it a control needed for your product? If so, what is the best way to implement it?

These are questions that have been challenging operations and their filtration experts since the inclusion of PUSPIT in Annex 1. Finding the correct answers has become increasingly significant with the ongoing debate about the wording and interpretation in the current Annex 1 redraft.

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