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Contact Suppliervalidated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:
A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
Statistical analysis for cleanroom parameters is encouraged as a tool for monitoring the cleanroom after certification to ensure compliance. The tool of choice is statistical process control, SPC.
Methods for evaluation and measurements for Certification are specified in ISO14644-3. It calls out for the following ten tests.
Air flow Test & ACPH Calculations
Installed Filter System Leakage Test (using PAO)
Non-Viable Particle Count Test
Recovery Test
Air Flow Pattern Test (Using Water Fogger)
Air Pressure Balancing
Containment test
Temperature & RH Measurement
Light Intensity Measurement
Sound Level Measurement
Once certified to a particular class the cleanroom factors are monitored to ensure that parameters have not drifted, or changed and that the environment is under control