CEM is accredited with the National Environmental Balancing Bureau (NEBB) for Cleanroom Performance Testing. We specialize in the testing, certification, repair and maintenance service of Cleanrooms and other Controlled Environments.

All testing provided by CEM is provided with calibrated instrumentation in accordance with the appropriate industry test standard and /or guideline. Cleanrooms are tested and certified to cGMP, ISO 14644, IEST-006, CETA and client specifications. The testing of each Cleanroom includes a custom report outlining the final results in detail.

CEM currently provides testing and certification for the following types of cleanrooms and controlled environments:

  • Pharmacy Compounding Suites
  • Research / Biotechnology Facilities
  • OR Surgery Suites / Healthcare Facilities
  • Nano Fab Cleanrooms
  • Medical Device Facilities
  • Hospital Isolation Patient Suite (Positive / Negative)
  • Animal Holding Rooms

Listed below are the services provided by CEM. Depending on the facility and related industry, the appropriate scope of testing shall apply.

Cleanroom / Controlled Environment Testing Services

Airflow Volume Measurements: Testing verifies that turbulent (non-unidirectional) Cleanrooms are properly air balanced and achieving an adequate air exchange rate

Air Velocity Profile: Verifies non-turbulent (unidirectional) Cleanrooms and Work Stations are properly air balanced and maintaining unidirectional flow patterns

Room Air Exchange Rates: Verifies Cleanroom is meeting design specification and/or acceptance criteria for airflow

Room Pressure Measurement: Ensures the room is properly balanced and meeting its design criteria in relation to the adjacent area

Non-Viable Particle Counting: Testing provided to verify Cleanroom is meeting designed air cleanliness classification level per ISO 14644 specifications

Viable / Microbial Air Testing: Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters per the Cleanroom design or client specifications

Viable / Microbial Surface Testing: Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters per the Cleanroom design or client specifications

In-Place Leak Testing of HEPA Filters: The integrity testing verifies the HEPA filters are free of leaks and are sealed properly

Temperature, Relative Humidity Measurements: Verifies the Cleanroom is operating within its design specifications

Lighting Measurement: Verifies the lighting level is meeting the Cleanroom design level or worker comfort level

Sound Level Measurement: Verifies the sound level is not exceeding the Cleanroom design or worker comfort level



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