A cleanroom is a controlled environment, specifically one that controls the level of contamination from particles, along with other factors such as temperature, humidity, static electricity, etc. Controlling all these variables protects your processes and products from contamination or conditions that could compromise the integrity of those products and processes.
Cleanrooms are required to meet specific standards as to the number of particles acceptable within the space, and to meet that standard, the cleanroom is regularly tested. Equipment and systems are put in place to maintain the cleanroom environment, including filtration systems, air flow systems, and access control procedures for entering the spaces, such as airlocks (MAL and PAL), Pass through boxes, Air showers for both materials and people. Lab coats or gowning for personnel working in the cleanrooms. In a nutshell, clean rooms are those rooms that meet the code of GMP requirements as defined in the sterile code of GMP, i.e. Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidelines set by local health authorities.
