Validation is an important process for any cleanroom. It serves to ensure that the cleanroom is properly designed for its intended ISO classification and that all of the components (facility, environment, equipment) meet regulatory requirements and other defined standards. So what’s the cleanroom validation process?
Most often, cleanrooms are validated by third-party validation agencies. This entails a thorough inspection and several tests, whereafter the cleanroom is certified to a specific class indicating its level of control, usually to an ISO14544-1 class.
Validation has several phases, beginning with design qualification, and ending in final certification. Some of the tests performed in these phases include airflow volume and velocity tests, HEPA/ULPA filter leak testing, air movement visualization (smoke testing), room pressurization, room recovery, airborne particle count tests, relative humidity, temperature, and other testing conditions.
Certification consists of three main phases. Installation qualification is also referred to as Phase 1 or “As built” testing. Testing is performed with all services connected and working, but no materials, production equipment, or employees present, proving that the equipment is correctly installed
Phase 2 is the operational qualification or “At rest” testing. Testing occurs when equipment is installed but not operating, and no employees are present. This proves that the equipment works properly to achieve the required environmental conditions.
Phase 3 is what is referred to as performance qualification. In this phase, testing is performed with all equipment installed and operating and employees performing their regular work duties and tasks. This testing proves that the cleanroom has the required operational performance for the cleanroom application.
Once initial certification is complete, it is important to regularly recertify to ensure that your cleanroom continues to operate as it did when it was built. At a minimum, annual certification is recommended. Depending on industry and product, semi-annual or even quarterly certification may be required.
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