Filling Isolator (Vial / PFS / Cartridge)
Parenteral drug filling demands bio-burden-free aseptic environments to ensure product sterility, integrity and safety. Fabtech’s Aseptic Filling isolators enclose the filling lines for batch production of Vials/PFS/Cartridges with ISO 5 Grade A unidirectional airflow within the working chamber. These are dedicated air handling units with 80-20 or 90-10 air circulation.
Specifications
Robustly constructed in SS 316L with Laminar airflow ISO 5 Grade A classification
Customizable ergonomics
Standard configuration includes one Pass Box (2 Glove Ports) and main chamber (4 Glove Ports), and a glove integrity tester. Multiple chamber configuration options are available
On-demand process equipment and online particle counter integration
LAF Covered openings to ensure robust sterility
Rapid Transfer Port for safe transfers. Integration with the filling line at various speeds for optimal performance
Simplified transfer of Rubber Bungs and Aluminum Caps using FabLife’s proprietary transfer mechanisms
H2O2 decontamination unit is integrated with the isolator and process for a seamless process operation
Password protection for different authorisation levels
Optional IPC SCADA 21CFR for high-grade integration and compliance
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