Microfiltration filtration system MANPUPSIT series

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Sterile filtration system designed for PUPSIT to meet EU GMP Annex 1 requirements on manufacture of sterile medicinal products. Overview The Cytiva™ manual drug product filtration system performs the sterile filtration of drug product. The system is designed to support the EU GMP Annex 1: Manufacture of sterile medicinal products by manually performing pre-use post sterilization integrity testing (PUPSIT) of the sterilizing-grade filters. Minimize sterility breach with flow kits tested before and after sterile filtration of drug product. Reduce time to implementation with ready-to-order standardized hardware and flow kits. Movable valves accommodate a wide variety of single-use filtration flow kits with different filter sizes and configurations. Economic, simple, and compact design. Using decades of experience in PUPSIT design, this ready-to-order PUPSIT solution includes both standardized hardware for consistent installation and standardized consumables for greater flexibility. By reducing the risk of incorrect installation and minimizing the time to implementation, our manual drug product filtration system allows you to meet EU GMP Annex 1 requirements with ease and confidence. Manual leak and integrity testing Integrity and leak testing ensure a defect-free single-use flow kit prior to committing the drug product. Using manually operated valves, the manual drug product filtration system can perform an integrity test, before and after sterile filtration. The Palltronic Flowstar V integrity test instrument can perform either a bubble point or forward flow integrity test. A leak test can be performed with the Palltronic Flowstar LGR integrity test instrument.