Munit operates state-of-the-art cleanrooms and high-containment isolators dedicated to API micronization. Our infrastructure ensures full GMP compliance, environmental control, and operator safety during powder processing.
Cleanroom Classifications and Zones
We offer multiple cleanroom grades (ISO 8 to ISO 5), including:
- Dedicated micronization rooms
- Airlocks and material pass-throughs
- Zoning for high-potency APIs
All rooms are monitored for particulates, temperature, humidity, and pressure differentials.
Containment for HPAPI and Cytotoxics
High-risk materials are processed in OEB5 isolators inside classified rooms. Equipment is configured for dust-free transfer, HEPA filtration, and inert conditions, supporting a wide range of APIs.
Cleaning Validation and Documentation
Each batch is supported by:
- Environmental monitoring reports
- Cleaning validation protocols
- GMP batch records and traceability logs
Our facilities are routinely audited and qualified by regulatory agencies and clients.
Process your APIs in world-class cleanroom environments.
Schedule a facility tour or virtual audit with Munit.