Modular sterility testing isolator for pharmaceuticals

Ensures Sterility in Pharmaceutical Loading and Testing

The MSTI – Modular Sterility Testing Isolator from Comecer provides pharmaceutical manufacturers and radiopharmaceutical producers with a cutting-edge solution for ensuring sterility in a variety of applications. This modular system is specially designed for aseptic processing, offering flexibility with its customizable configuration to meet specific operational needs. It features a fully enclosed Grade A environment suitable for installation in Grade D areas. The MSTI integrates a vapor-phase hydrogen peroxide (VPHP) decontamination system that guarantees a 6-log reduction, ensuring thorough sterilization of all internal volumes with rapid cycle times.

Ideal for testing sterile injectable drugs, vaccine vials, and pre-filled syringes, the system supports various processes such as material loading, decontamination, and sterility testing. You can expect seamless integration within your production line as it operates continuously and is ready to use. Equipped with a peristaltic pump and racks for vials, ampoules, and other samples, the MSTI facilitates efficient handling and positioning of materials. The system boasts compliance with CFR21 Part 11, ensuring data integrity and meeting stringent pharmaceutical standards.

To boost efficiency, the MSTI features the Illuminate™ Manufacturing Intelligence platform, allowing real-time monitoring and data analysis to optimize production processes and minimize downtime. This isolator presents a robust solution for biotech, pharmaceutical, and hospital pharmacy sectors, offering reliability and versatility in demanding sterility testing environments.