Article | December 5, 2024

Guide To PUPSIT And Annex 1 In Aseptic Processing

Source: Cytiva
GettyImages-1337837329 regulatory, paperwork, writing

Aseptic processing is critical for ensuring the sterility, safety, and quality of medicinal products. Filtration, a key step, uses sterilizing-grade filters that must undergo integrity testing to confirm structural soundness and reduce contamination risks. Integrity testing may occur pre-use, post-sterilization, and/or post-use, depending on regulatory guidelines. Notably, pre-use, post-sterilization integrity testing (PUPSIT) is required under EU GMP Annex 1 unless a risk assessment justifies its exclusion. PUPSIT verifies the filter’s integrity after sterilization but before use, ensuring no damage occurred during handling or sterilization.

A robust contamination control strategy (CCS) incorporates filter integrity testing to manage risks to product quality. While the US FDA requires post-use testing for batch release, EU guidelines emphasize PUPSIT for additional sterility assurance. However, performing PUPSIT introduces potential risks, such as operator errors or sterile pathway breaches, which can be mitigated through optimized system designs, operator training, and automated solutions.

Advanced solutions like Cytiva's manual and automated systems streamline PUPSIT implementation, reducing risks and ensuring compliance. Automated systems offer recipe-driven consistency, minimized human intervention, and enhanced data integrity, while manual systems provide flexible, ready-to-use configurations. Fast Trak™ validation services support biomanufacturers with microbial retention testing, risk assessments, and regulatory compliance.

As global regulatory positions evolve, PUPSIT remains a cornerstone of aseptic processing. Innovations in testing systems and risk management strategies ensure biomanufacturers maintain sterility, improve efficiency, and meet stringent guidelines for sterile drug production.

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