Sterility testing isolator for pharmaceutical labs
Ensuring the sterility of drugs, components, and devices is critical before their release to patients. Traditional cleanrooms can be complex and require rigorous maintenance to prevent contamination, posing challenges for high productivity and reliable sterility testing.
Enables continuous sterility testing and reliable bio-decontamination
The Getinge ISOTEST isolator is designed to optimize sterility testing workflows for sterile drugs, components, and devices. This isolator provides a completely closed system that ensures a controlled sterile environment, reducing the risk of false-positive results. Unlike cleanrooms, the isolator offers a more manageable environment where contamination sources can be detected and controlled efficiently. It supports various sterility testing methods including closed or open membrane filtration, direct inoculation, and rapid microbiology methods. The dual-operator design increases productivity by allowing two users to work simultaneously. A single Siemens PLC control system validates and monitors critical parameters, ensuring traceability and integration with customer networks. Bio-decontamination cycles are short, facilitating up to 40 tests per 8-hour shift with rapid hydrogen peroxide vapor decontamination.
Benefits
- Reduces risk of false-positive results
- Increases productivity with dual-operator access
- Ensures traceability with integrated process control
- Short bio-decontamination cycles enhance throughput
- Supports various sterility testing methods