Sterility test isolator for pharmaceutical processes
In pharmaceutical production, ensuring sterility is crucial to prevent contamination of products. False results in sterility testing can lead to increased costs and production delays due to the need for re-testing and validation processes.
Ensures aseptic environment for sterility testing
The Pura Sterility Test Isolator from Telstar provides a reliable aseptic environment for sterility testing and other aseptic processes. Designed to minimize the risk of false results, the isolator consistently achieves a log 6 reduction in spore-forming microorganisms. It features unidirectional Grade A recirculatory airflow (ISO 4.8), a positive pressure environment, and a rapid validated Log 6 bioburden reduction system. The isolator is equipped with Telstar’s unique ionHP+ H2O2 based bio-decontamination system and offers configurable options including direct inoculation and filter membrane sterility tests. Made from 316 stainless steel and toughened safety glass, the isolator complies with ISO and GMP guidelines and integrates smoothly with OEM and third-party equipment.
Benefits
- Minimizes contamination risk
- Consistent log 6 reduction in spore-forming microorganisms
- Complies with ISO and GMP guidelines
- Configurable options for integration
- Rapid validated bioburden reduction