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.

This is usually on an annual basis however the revision of Annex 1 looks to change the requirement to every 6 months for Grade B rooms and Grade A equipment.

It provides an ongoing assurance that facilities and equipment can continue to meet their original specifications.

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
DQ ProcessFAT-SAT-IQOQ-PQ

Cleanroom Validation  

GMP Cleanrooms  

Contact Us