Commissioning and Validation

Cleanroom Commissioning

Commissioning is a systematic process of assuring that a building performs in accordance with the design intent and the owner’s operational needs.
———1993 National Conference on Building Commissioning

After installation and construction of cleanroom system, each component of cleanroom should be tested and every system should be conducted trial running first.

Normally, cleanroom system should be tested for the following aspects, and the tested results shall be recorded as one part of documentation work.

• Air velocity
• Filter Airflow rate
• Temperature and Humidity
• Filter leakage test
• Room pressurization & Differential Pressure
• Cleanliness classification

Cleanroom Validation

After cleanroom commissioning, we should validate the cleanroom system, and we must ensure

•  the design of the facility is fit for its intended purpose;
• the facility, equipment, and environment meets User Requirement
•  the facility, equipment, and environment meet defined regulatory requirements;
• the facility, equipment, and its environment function together as a system to meet defined standards

In the meantime, the validation documentation is also required in this process, including Operation Qualification(OQ) and Performance Qualification(PQ)

Validation Documentation consists of

• Design Qualification
• Installation Qualification
• Operation Qualification
• Performance Qualification