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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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.
At October’s PDA/BioPhorum meeting in Berlin, it was agreed that the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) consortium would be renamed Sterile Filtration Quality Risk Management (SFQRM).
May 2017 | Technology Roadmapping
This chapter of the First edition Biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective in-line monitoring and real-time release capabilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.