Cleanrooms: The Backbone of Microchem’s Industry-Leading Sterility Testing
Microchem didn’t want our sterility testing services to be ordinary. Starting around 18 months ago we carefully laid the framework for an industry-leading offering, including the construction of a state-of-the-art cleanroom to bring the best possible testing to our valued clients.
The cleanroom creates an aseptic, positive-pressure, closed environment to ensure optimal conditions for sterility testing. It is qualified and monitored to meet the stringent requirements for an ISO 7 classification. The cleanroom was expertly built by KTEC and far exceeded ISO 7 standards during initial qualification testing.
Key features include:
- Aseptic Positive Pressure: Maintains a contamination-free environment by preventing unfiltered air from entering the cleanroom.
- ISO 7 Classification: Ensures that the cleanroom adheres to the highest standards of cleanliness, limiting the number of airborne particles to 352,000 particles of ≥0.5 μm size per cubic meter.
- Static Pressure Gauges: These are calibrated to ensure the proper range of pressure differentials are maintained, guaranteeing the integrity of the cleanroom environment.
- Robust gowning, cleaning, and environmental monitoring procedures.
In the heart of our cleanroom is a large laminar flow hood, designated as the “critical” area for our sterility testing processes. This hood meets the requirements for an ISO 5 classification, providing an ultra-clean environment essential for sensitive testing procedures.
The laminar flow hood ensures:
- ISO 5 particulate control
- Enhanced Sterility: Offers a sterile workspace for critical testing activities, minimizing the risk of microbial contamination.
For more information about our cleanroom and sterility testing services, please visit our website or contact the lab.
