Cleanroom validation is the documented process of proving that a cleanroom consistently performs according to its design specifications. The validation process follows a logical sequence:
Step 1: Design Qualification (DQ)
Verify that the cleanroom design meets user requirements and regulatory standards before construction begins.
Step 2: Installation Qualification (IQ)
Verify that all equipment and systems are installed correctly according to specifications. Check component identification, documentation, calibration status, materials of construction, and utility connections.
Step 3: Operational Qualification (OQ)
Verify that the cleanroom and its systems operate within specified limits under all anticipated operating conditions.
Step 4: Performance Qualification (PQ)
Verify that the cleanroom consistently performs according to specifications under actual operating conditions with personnel and processes in place.