PUPSIT: identifying risks and preventive controls

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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 PUPSIT through a series of online webinars, and host of articles and best practice papers.

One such paper in the series Points to Consider for the Risks Associated with Sterilizing Grade Filters and Sterilizing Filtrationhas been published by PDA and was developed by the BioPhorum/PDA Sterilizing Filtration Quality Risk Management Consortium. The paper gives the reader a thorough understanding of the risks and risk assessments that must be considered when evaluating sterilizing grade filters and sterilizing filtration, including the evaluation of risk associated with PUPSIT.

The authors provide detailed guidance on the use of the fault tree analysis and failure mode and effective analysis (FTA and FMEA) tools to identify, analyze, and evaluate risks, and risk controls intended to prevent sterilizing-grade filter failure. The overall risk to patient safety is discussed, focusing on the level of control over each identified risk.

This points to consider (PtC) document is the first of two PtC documents produced by the multicompany consortium comprising more than 50 subject matter experts from 25 biopharmaceutical manufacturing companies and filter suppliers. The consortium was formed by BioPhorum and PDA to consider the different aspects of sterile filtration risk management. 

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