Significance of the concept of 'Cleanroom'

Maintenance of a Clean room needs utmost care and control, and this can be accomplished by proper design of that room, availability of testing equipments and skilled technicians, and regular monitoring in order to maintain it.

A number of environmental factors need to be controlled within specified limits in order to maintain a Clean room. These are Temperature, Air-borne particulates, Microbial particles, Relative humidity, Differential pressure, and Air Flow. Although the design of a Clean room involves quite a complicated methodology, the basic design can be summarized to employ increased air supply, use of high efficiency filters like HEPA (High Efficiency Particulate Air) & ULPA (Ultra Low Penetration Air), & room pressurization. The execution of Clean room Validation is accomplished through five steps, and they are: Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification, and Control Monitor. The laboratories that provide Cleanroom Validation & Designing follow ISO 14644, and some of the tests required for evaluation and certification of Cleanroom are Airborne Particle count test, Airflow (Laminar Flow) Velocity test, Air Pressure differential test, Installed Filter leakage test, Airflow visualization test, and Airflow direction test.The frequency of conducting such tests is also a matter of importance and needs to be followed scrupulously. Classification of Clean room to various grades is done according to ISO 14644-1, BS 5295, and Federal standard 209E. ISO 14644 though is the current regulatory standard.