Sterility testing isolator for aseptic environments
Ensuring product sterility in pharmaceutical and biotech industries is crucial to maintaining product safety and quality. Traditional cleanrooms can sometimes fall short in providing the required sterility, making robust, controlled environments necessary.
Perform sterility tests in a controlled aseptic environment
The Sterility Testing Isolator by Fabtech is designed to allow operators to perform sterility tests in a controlled and aseptic environment, ensuring product and process integrity. Constructed with robust SS 316L material and classified under ISO 5 Grade A for laminar airflow, it provides a high level of decontamination compatible with VHP. The standard configuration includes one Pass Box with 2 Glove Ports, a main chamber with 4 Glove Ports, and a glove integrity tester. Customizable ergonomic options allow for user-specific configurations, while optional H2O2 decontamination offers additional safety measures. The system also supports on-demand process equipment and online particle counter integration for enhanced monitoring. Multiple chamber configurations are available, and the system includes password protection for different authorization levels, making it both secure and versatile for various applications within the pharmaceutical and biotech fields.
Benefits
- Ensures high sterility with ISO 5 Grade A laminar airflow
- Customizable configurations enhance ergonomic functionality
- Supports VHP and optional H2O2 decontamination for additional safety
- Integrated particle counter for real-time monitoring
- Password-protected for secure usage across authorization levels