Ongoing Performance Qualification

Requalification

Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensure that its operation continues to meet initial requirements as the facility ages. This is also described as requalification or re-validation. Ongoing Performance Qualification provides an ongoing assurance that facilities and equipment continue to meet their original specifications.

ISO 14644-2 recommends to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes. The suggested maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months, and ISO class 6 and above is 12 months.

Tests may include but not be limited to:

  • As built/At rest Particle Counts
  • Air Volumes and Air Change Rates
  • Filter Integrity Testing
  • Pressure Differentials
  • Temperature and Humidity Levels
  • Recovery Rate Testing
  • Smoke Visualisation Airflows
  • Containment Leak Testing
  • Light (Lux) Level Testing
  • Sound Level Testing
  • Door interlocks Testing

Cleanroom Validation  

Advanced Manufacturing Cleanrooms  

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