Cleanrooms play a crucial role in maintaining contamination free production environments for critical processes. A well-executed cleanroom certification and testing program is essential to proper cleanroom maintenance, operation, and regulatory compliance.
In accordance with regulatory standards, cleanrooms must be certified at time of construction and at least annually thereafter. Quarterly and semi-annual certification considerations are given based on operational requirements, risk assessment of the installation, and use.
Primary Cleanroom Tests (must pass to be certified)
- Testing of containment devices within the cleanroom space(s): Biological Safety Cabinets, Laminar Flow Benches, Chemical Fume Hoods, etc. (See procedural specifications for these devices.)
- Non-Viable Airborne Particle Count Testing
- HEPA Filter Leak / Challenge Testing
- Airflow Velocity / Volume Testing
- Room Air Change Rate(s)
- Room Differential Pressure Testing
Secondary Cleanroom Tests
- Temperature / Relative Humidity Testing
- Room Differential Pressure Gage Calibration
Detailed Summary Report: