Cleanroom Testing and Certification

LE3 offers comprehensive services to ensure your cleanroom complies with regulatory standards, including USP 797/800

 

Cleanrooms provide a controlled “clean” environment by removing airborne particles like microbes and dust by filtering the air and controlling environmental conditions like temperature, airflow, and humidity. A cleanroom is classified by the level of contamination measured in particles per cubic meter.
A cleanroom may be used for scientific research or specialized production, including manufacturing pharmaceuticals, integrated circuits, optics, aerospace assembly, nanotechnology production, military applications, and medical device assembly. Additionally, clean rooms can be used for compounding pharmacies, biopharmaceuticals, or infusion.

 

Cleanroom Testing

Cleanrooms must perform to specific standards such as ISO14644-1, ISO 144644-2, ISO 14644-3, IEST, and cGMP. In addition, many organizations are required by law to test their rooms annually.

 

The testing we perform:

  • HEPA filter integrity testing
  • Non-viable particle counting
  • Temperature / relative humidity testing
  • Airflow visualization testing
  • Viable environmental monitoring – EM
  • Compressed gas testing – compressed dry air (CDA) testing
  • Lighting, vibration, and sound testing

Cleanroom Certification

LE3 can provide you with clean room certification at the completing of testing.