Cleanroom Testing & Certification

Cleanrooms play a crucial role in maintaining contamination free production environments for critical processes.  A well-executed cleanroom certification and testing program is essential to proper cleanroom maintenance, operation, and regulatory compliance.

 

In accordance with regulatory standards, cleanrooms must be certified at time of construction and at least annually thereafter.  Quarterly and semi-annual certification considerations are given based on operational requirements, risk assessment of the installation, and use.

 

Primary Cleanroom Tests (must pass to be certified)

• Testing of containment devices within the cleanroom space(s): Biological Safety Cabinets, Laminar Flow Benches, Chemical Fume Hoods, etc. (See procedural specifications for these devices.)
• Non-Viable Airborne Particle Count Testing
• HEPA Filter Leak / Challenge Testing
• Airflow Velocity / Volume Testing
• Room Air Change Rate(s)
• Room Differential Pressure Testing

Secondary Cleanroom Tests

• Temperature / Relative Humidity Testing
• Room Differential Pressure Gage Calibration

 

Detailed Summary Report:

Standards Utilized:

All performance testing datasheets contain reference number, testing standard used, date of test, and person who performed the testing. A comprehensive computer generated report will be furnished indicating any required recommendations. As part of our comprehensive report we provide drawings of cleanroom space(s) with location of HEPA filters, equipment, gauges, direction of room pressures, and non-viable airborne particle count testing locations. Prepare and submit a budgetary proposal for any items deemed defective and/or requiring repair.

CETA, Controlled Environmental Testing Association IEST, Institute of Environmental Science and Technology ISO 14644, International Organization for Standardization NEBB National Environmental Balancing Bureau ACGIH, American Conference of Governmental Industrial Hygienists Equipment manufacturer specifications

 

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