A clean room needs to remove pollutants such as particles, harmful air, and bacteria from the air within a certain range, and control the temperature, cleanliness, indoor pressure, airflow speed and distribution, noise, vibration, lighting, and static electricity in a dust-free room within a certain range of requirements. Typically, a clean room is classified based on the number of particles in the laboratory air.
It should be noted that the classification of levels A, B, C, and D is based on ISO standards (adopted by the European Union), which themselves include static and dynamic requirements. The old version of GMP adopted the clean room classification method in the United States, which only had a static concept and did not require dynamic classification.
Clean rooms are classified according to the degree of air cleanliness. If the level of a clean room is described only by the number of dust particles, it can be assumed that the size of the dust particles is 0.5 μ m. For example, the number of large dust particles in level 1, level 10, and level 100 clean rooms is less than or equal to 1, 10, and 100, respectively. If the dust particle size is not 0.5 μ m. The level of a clean room should be represented by the number of levels in a specific dust particle size, which are divided into levels 1, 10, 100, 1000, 10000, and 100000. The smaller the value, the higher the purification level, and the higher the cleanliness, the higher the cost.
Requirements for cleanliness levels in various industries
The purification requirements for clean rooms vary among industries:
Level 1: Mainly used in the microelectronics industry for manufacturing integrated circuits, with a precision requirement of submicron for integrated circuits.
Level 10: Mainly used in semiconductor industries with bandwidth less than 2 microns.
Level 100: Suitable for sterile manufacturing processes in the pharmaceutical industry.
Class 1000: mainly used for the production of high-quality optical products, as well as for testing, assembling aircraft snails, and assembling high-quality micro bearings.
Class 10000: mainly used for the assembly of hydraulic or pneumatic equipment, and in some cases also used in the food and beverage industry. In addition, Class 10000 clean rooms are also commonly used in the medical industry.
Class 100000: Class 100000 clean rooms are used in many industrial sectors, such as the manufacturing of optical products, the manufacturing of small components, large electronic systems, hydraulic or pneumatic systems, food and beverage production, and the medical and pharmaceutical industries.