Cleanroom Testing and Certification Services
Regulatory Guidance / Test Methods:
We test and certify cleanrooms to ensure that facilities are compliant with the required standards and customer specifications. Our services are designed to meet regulatory, industry, and certification requirements according to various standards including: ISO, cGMP, CNBT, NSF, FDA, IEST, among others.
Cleanrooms should be certified annually at a minimum to ensure compliance with industry, regulatory, and client standards. Some clients certify every 3 or 6 months. In addition, tests should be performed after any significant changes in the cleanroom (i.e construction, equipment upgrades)
Primary Services
Filter Airflow Volume/Velocity and Uniformity
Ensures unidirectional and non-unidirectional flow areas are properly balanced and zones are maintaining adequate air patterns.
Filter leak tests
Documents leakage or defects and ensures HEPA filters for cleanroom provide the required filtration.
Non-viable particle counting cleanliness test
Conducted per ISO14644, reports the amount of airborne particulate of a specified size in the clean environment.
Room pressurization
Verifies that the room differential pressures meet regulatory requirements.
Additional Services
Airflow visualization
Verifies airflow direction using a source of visible fog.
Temp/RH% Testing
Confirms whether HVAC controls are functioning properly and uniformly.
Light level testing
Performed to design specifications for worker comfort.
Sounds Level testing
Performed to design specifications for worker comfort.
Magnehelic gauge calibration and installation
Ensures gauges are calibrated to regulatory standards.
HEPA filter replacement
Replace any faulty / non-fixable HEPA filters.
Room recovery testing
Performed to determine whether an area is capable of returning to a specified cleanliness level after non-routine exposure events.
Compressed Air/Gas Testing
Ensures compressed air and gas systems meet the requirements of the cleanroom.
Viable air and surface sampling
Determines if any bacterial and fungal contamination is present.
Mag Gauge Testing / Installation / Calibration
Ensures mag gauges are functioning according to equipment and regulatory standards.
