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.
'Cleanroom' as the name suggests refers to a room, space, or a particular confinement which is quite clean. But having said that, when we are talking of a scientific process any system needs to be quantified, and the same goes for a 'Cleanroom'. Although there are a number of different standard definitions of cleanroom, it can be defined as " A room where there is a controlled level of contamination, and the contaminants can be dust, bacteria, mold, electro-static discharge etc." The level of contamination is quantified by the number of air particles/particulates, of a particular particle size, per unit volume (generally cubic metre).
The concept of Cleanroom and Cleanroom service has received prominence in a number of industries and service providers which lay emphasis on precision like semi-conductor/electronics, microelectronics, aerospace, pharmaceuticals, hospitals, microbiological laboratories, and other sophisticated equipment manufacturers. Since the work of maintaining a cleanroom is quite complicated, the varieties of jobs also vary. The expertise level range from that of low-skilled workers to that of highly skilled engineers and microbiologists. But all the technicians related to Clean Room Validation need to be thoroughly trained in the basic points, like wearing protective gears like masks, gloves, headgears etc., and also maintaining and following certain protocols related to the process of entering, exiting, and other movements inside that 'Contamination-free' room. Hence the job, in general, needs a lot of painstaking efforts on the part of all the technicians.
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.
