A clean room is a modular environment in which the following environmental factors are kept under control;
- Temperature
- Airborne particulates
- Microbes
- Relative humidity
- Differential pressure
- Air flow.
Clean room Validation is performed,
- To ensure that the design of the facility is fit for its intended purpose.
- To ensure that the facility, equipment, and environment meets User Requirement Specifications (URS).
- To ensure that the facility, equipment, and environment meet defined regulatory requirements.
- To ensure that the facility, equipment, and its environment function together as a system to meet defined standards.
Following tests are carried out during facility validation
- Light intensity testing
- Sound level testing
Clean rooms are validated and then certified to a chosen class of ISO 14644-1 : 2015 Each class of ISO14644-1:2015, has its unique requirements that must be made for a facility to be classified in the specified classification.
Clean Room / HVAC Validation tests:
- Air Velocity Test And Calculation of ACPH
- Air Balancing
- Installed HEPA Filter Leakage (Integrity) Testing – PAO.
- Airborne particle measurement (Non-Viable Particle Count)
- Recovery test
- Air Flow Direction / Pattern test (Smoke Study)