Modular sterility testing isolator for pharmaceuticals
In pharmaceutical laboratories, maintaining aseptic conditions is crucial for accurate sterility testing of products. Traditional methods may not meet rigorous standards, resulting in compromised test results or potential contamination. Therefore, a reliable solution is required to ensure sterility throughout the process.
Ensures aseptic testing conditions
The MSTI is a Modular Sterility Testing Isolator System from Comecer designed specifically for pharmaceutical sterility testing. It features a Grade A fully closed isolator with laminar airflow, enhancing contamination control. The system includes a VPHP decontamination generator for rapid decontamination cycles and integrates with the Illuminate™ MI platform for real-time performance data. It can accommodate various pharmaceutical containers like vials, ampoules, syringes, and cartridges, thanks to its customized internal solutions. This flexibility, combined with compliance to CFR21 Part 11 and Data Integrity requirements, makes it an efficient and user-friendly option for lab professionals.
Benefits
- Ensures high-level aseptic conditions
- Quick decontamination process
- Customizable for different sample types
- Compatible with factory-floor management platforms
- Complies with regulatory standards for data integrity