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.

其中需要注意的，A、B、C、D级别的划分是参照ISO标准（欧盟采纳的方式），其本身包含了静态要求和动态要求。旧版GMP采纳的是美国的洁净间划分方式，旧版的洁净间划分仅有静态的概念，不要求动态。

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.

净室按空气清洁程度分类，如果无尘室的等级只用尘粒数目来叙述，则可假设尘粒的尺寸为0.5μm，例如，1级、10级、100级无尘室大尘埃粒子数目分别小于或等于1颗、10颗、100颗。如果尘粒尺寸不是0.5μm，无尘室等级应以在一特定尘粒尺寸的级数来表示，分别分为1级、10级、100级、1000级、10000级、100000级，数值越小，净化级别就越高，洁净度越高造价就越高。

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.

各行业对洁净度等级的要求

Requirements for cleanliness levels in various industries

各行业对洁净室的净化要求也有所不同：

The purification requirements for clean rooms vary among industries:

1级：主要用于制造集成电路的微电子工业，对集成电路的精确要求为亚微米。

Level 1: Mainly used in the microelectronics industry for manufacturing integrated circuits, with a precision requirement of submicron for integrated circuits.

10级：主要用于带宽小于2微米的半导体工业。

Level 10: Mainly used in semiconductor industries with bandwidth less than 2 microns.

100级：可用于医药工业的无菌制造工艺等。

Level 100: Suitable for sterile manufacturing processes in the pharmaceutical industry.

1000级：主要用于高质量光学产品的生产，还用于测试，装配飞机蛇螺仪，装配高质微型轴承等。

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.

10000级：主要用于液压设备或气压设备的装配，某些情况下也用于食品饮料工业，此外，万级洁净室在医工业中也很常用。

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.

100000级：十万级洁净室用于很多的工业部门，比如光学产品的制造，用于较小的元器件制造大型的电子系统，液压或气压系统的制造，食品饮料的生产，医、药工业也常常使用。

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.