Aseptic filling isolator for vial / Pfs / cartridge
Maintaining product sterility and integrity in parenteral drug production requires an environment free from bio-burden. This is essential to meet stringent regulatory standards and ensure patient safety.
Ensure sterile and safe drug filling
The Aseptic Filling Isolator by Fabtech is designed for batch production of Vials, Pre-Filled Syringes (PFS), and Cartridges. It features ISO 5 Grade A unidirectional airflow within the working chamber for maintaining a bio-burden-free environment. Constructed from robust SS 316L, the isolator includes customizable ergonomics to suit different operational needs. It integrates various components such as a Pass Box with 2 Glove Ports, a main chamber with 4 Glove Ports, and a glove integrity tester. Additional features like the Rapid Transfer Port, H2O2 decontamination unit, and optional IPC SCADA 21CFR compliance enhance the functionality and safety of the filling process. The scaled configurations can handle diverse production speeds, ensuring optimal performance.
Benefits
- Maintains ISO 5 Grade A environment
- Customizable ergonomics for user comfort
- Robust construction with SS 316L material
- Safe transfer with Rapid Transfer Port
- Integrated H2O2 decontamination for seamless operation