Phase Four: Performance Qualification
The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification involves testing and monitoring of the following:
• Airborne particulate levels
• Surface particulate levels
• Viable microbial particulates
• Relative humidity
• Differential pressure
• Temperature
The output of the PQ phase is a PQ report that analyzes the performance of the cleanroom using specified equipment parameters. PQ is a pre-requisite for certification.
Cleanroom Certification
Validated 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:
Methods for evaluation and measurements for Certification are specified in ISO14644-3. It calls out for the following ten tests.
• Airborne particle count test
• Airflow test
• Air pressure differencial test
• Filter leakage test
• Flow vizualization test
• Airflow direction test
• Temperature test
• Humidity test
• Recovery test
• Containment leak test
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.
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