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.
