Generally, there are grades in clean rooms. When multiple procedures are used, different air cleanliness grades should be used according to the different requirements of each procedure, and the grade should be determined according to the requirements of the procedure.
Air cleanliness class is a classification standard for the maximum concentration of particles greater than or equal to the particle size considered in the unit volume of air in a clean space.
The cleanliness level and the division of clean areas in the production process of pharmaceuticals in the pharmaceutical industry should be determined with reference to the preparation and API process content and the division of environmental areas in the "Pharmaceutical Production Quality Management Code". The air cleanliness of the pharmaceutical production clean room is divided into four levels.
Under the premise of meeting the requirements of the production process, firstly, low-grade clean wet or local air purification should be adopted; secondly, the combination of local working area air purification and the city-wide air purification or comprehensive air purification can be used.
|Air cleanliness level(N)||Greater than or equal to the maximum concentration limit of the particle size in the table(pc/m³)|
|8（One hundred thousand）||3520000||832000||29300|
|9（One million class）||35200000||8320000||293000|