Cleanroom Testing and Certification
Our Services
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.
LE3 can provide you with clean room certification at the completing of testing.
Testing
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
Compliance
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.
LE3 offers comprehensive services to ensure your cleanroom complies with regulatory standards, including USP 797/800