Manufactur standard Fresh Air Room - Ten thousand dust purification level – TekMax

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Manufactur standard Fresh Air Room - Ten thousand dust purification level – TekMax Detail:

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.

The cleanliness level of suspended particles in the air of clean rooms and clean areas

Air cleanliness level(N)	Greater than or equal to the maximum concentration limit of the particle size in the table(pc/m³)
Air cleanliness level(N)	0.1um	0.2um	0.3um	0.5um	1um	5um
1	10	2
2	100	24	10	4
3	1000	237	102	35	8
4（Ten）	10000	2370	1020	352	83
5（Hundred）	100000	23700	10200	3520	832	29
6（Thousand）	1000000	237000	102000	35200	8320	293
7（Ten thousand）				352000	83200	2930
8（One hundred thousand）				3520000	832000	29300
9（One million class）				35200000	8320000	293000

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