A cleanroom is a modular environment in which the following environmental factors are kept under control; temperature, airborne particulates, microbes, relative humidity, differential pressure, and air flow. 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 t
he 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. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification. CLEANROOM VALIDATION LIFE CYCLE
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.
