Cleanrooms are utilized to control airborne particulates and environmental conditions. Cleanroom testing requires adherence to specific performance requirements in the pharmaceutical, medical device and electronic industries. CERTS testing programs ensure that facilities are compliant with the required standards and specific customer specifications.
CERTS cleanroom testing services are designed and performed to meet industry, regulatory and certifications requirements including; ISO, Current Good Manufacturing Practices (cGMP), Institute of Environmental Sciences Technologies (IEST) and CNBT.
Primary Cleanroom Tests:
- Airflow volume/velocity readings assures that both unidirectional and non-unidirectional flow areas are properly balanced & unidirectional zones are maintaining proper air patterns.
- Room air exchange rates ensures the area is meeting its design airflow.
- HEPA filter integrity testing tests HEPA filters & system for leaks.
- Non-viable particle counting reports the amount of airborne particulate of a specified size in the clean zone.
- Temperature/relative humidity testing examines whether the air HVAC controls are uniformly functioning properly.
- Pressure cascade monitoring verifies that room differential pressures are operating according to design.
Additional Cleanroom Tests:
- Air balancing adjusts airflow in the air handling systems to achieve design specifications, room air exchange rates & pressure cascade.
- Airflow visualization testing qualitatively verifies airflow direction using a source of visible smoke.
- Viable environmental monitoring samples both the air and surface for microbial enumeration and identification.
- Compressed gas testing assures compressed gas sources meet the requirements of the controlled environment for contamination and microorganisms.
- Lighting, vibration and sound tests.
- Any other industry specific tests.