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