Clean rooms are special areas classified in terms of cleanliness class ISO 14 644 standard, depending on the amount of solid non-viable particles contained in an unit volume of air.
A room is not "clean" just because the air handling equipment was properly designed according to the standard (air flow amount, filters, pressures), but also because all the component materials in a clean room (walls, ceilings, floors , doors, ligt fixtures) must comply and be certified for this purpose.
Depending on their destination, clean rooms must meet additional conditions regarding the air flow inside the room, ie temperature, relative humidity and differential pressure, elements to be controlled and monitored. In this way clean rooms must meet specific conditions for a range of activities that are subject to standards such as:
GMP - Good Manufacturing Practice guide for medicinal products for human use;
GDP - Good Distribution Practice guide on the wholesale distribution of drugs, completed with existing requirements and standards in the following guides:
- EU GMP - EU Good Manufacture Practice;
- GLP - Good Laboratory Practice;
- GDP - Good Distribution Practice;
The applicability of clean rooms covers a wide range of activities such as:
- Pharmaceutical industry (production of medicines, microbiological laboratories, packaging, storage etc.)
- Healthcare (operating rooms, neonatology, sterilization stations)
- Food industry
- Microelectronics (semiconductors, microcomponente etc.)
- Research (laboratories)