Cleanroom Certification

Cleanroom Testing

Cleanrooms are utilized to control airborne particulates and environmental conditions. Cleanroom testing/certification 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 customers’ specifications.
CERTS cleanroom testing services are designed and performed to meet industry, regulatory and certification requirements including; ISO, Current Good Manufacturing Practices (cGMP), CNBT, NSF, FDA, Institute of Environmental Sciences Technologies (IEST).

Primary Cleanroom Tests

  • Non-viable particle counting reports the amount of airborne particulate of a specified size in the cleanroom, which allows the room to be classified under ISO 14644.
  • HEPA filter integrity testing tests HEPA filters & filter banks for leaks.
  • Airflow volume/velocity readings assures that both unidirectional and non-unidirectional flow areas are properly balanced. This test also helps to trend HEPA filter life expectancy.
  • Room pressure differentials ensure that the cleanroom is operating with proper pressure cascade for all classifications.
  • Room air exchange rates ensure the area is meeting its design criteria.
  • Temperature/relative humidity testing determines whether the environmental conditions required are being meant.
  • Airflow visualization/smoke study testing qualitatively verifies airflow patterns using a source of visible smoke.
  • Viable/microbial monitoring samples both the air and surface for microbial enumeration and identification.

Additional Cleanroom Tests

  • Light, vibration and sound testing
  • Air balancing adjusts airflow in the air handling systems to achieve design specifications, room air exchange rates & pressure cascade.
  • Testing of cleanroom pressure gauges.
  • Compressed air testing assures the compressed air system will meet the requirements of the environment for contamination and microorganisms.
  • Any other industry specific tests.

Our staff is trained and experienced in compliance with the latest standards:

  • ISO 17025 Certificate
  • ISO 14644
  • NSF-49
  • IEST
  • USP (797/800/795/825)

Our Certifications

ISO 17025 Certificate
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