无菌灌装

The Cytiva™ drug product filtration system operates using configurable recipe-controlled phases to automatically perform terminal sterilization prior to filling with maximum product recovery using standard flow kits. It has been designed to support EU GMP Annex 1: Manufacture of sterile medicinal products requirements for contamination control strategies with automated in situ pre-use post-sterilisation integrity testing (PUPSIT) and post-use integrity testing of sterile filters.

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.

Enable small-batch flexibility and standardized manufacturing with this closed robotic isolator for pharmaceutical vial filling. Whether you’re making personalized medicines or clinical trial material, it’s built for agility and quick changeover.

用于注射剂瓶、预灌封注射器和卡式瓶的灵活灌装并降低风险的无手套隔离器系统。