Modular Gmp isolator for aseptic processing
In the pharmaceutical and biotech industries, ensuring an aseptic environment during the transfer, manipulation, and testing of materials is critical. Contamination can lead to significant product loss and safety risks, making the need for reliable containment solutions paramount.
Ensure sterile conditions with modular containment
The ISOFLEX by Getinge is a modular aseptic GMP isolator designed to maintain an enclosed and sterile environment throughout various processes, such as sterility testing and aseptic processing. A key feature is its modular design, which allows customization to meet specific process requirements. The isolator offers flexibility with its three-glove or four-glove versions, large front window for ergonomic loading, and options for bio-decontamination airlocks. The ventilation system can be configured for either Engineered Turbulent Flow (ETF) or Unidirectional Airflow (UDAF), ensuring the appropriate sterile conditions for different applications. Additionally, advanced process control is achieved via Siemens or Allen Bradley PLC systems, complemented by a 19” touch panel PC for easy operation. The system is FDA 21 CFR Part 11 compliant, ensuring it meets stringent regulatory standards.
Benefits
- Customizable modular design
- Flexible ventilation options for specific process needs
- Advanced process control with full traceability
- Efficient bio-decontamination alternatives
- Ergonomic and easy to use design