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Cleanrooms

A closed environment that has a controlled level of environmental pollutants (particles) and which is used for manufacturing or research is called a cleanroom.
Cleanrooms are not sterile and the contamination of cleanroom is defined by amount of foreign particles per cubic meter at a specified size of particle; the number of particles is measured by particle counter.


Cleanrooms are used in pharmaceutical and electronics manufacturing, biotechnology research and other fields where the contamination of air is critical.
There are several ways which can be used separately or complexly to control the composition of air entering the cleanroom:
-          filtering system which consists of HEPA (high efficiency particulate air) and ULPA (ultra low particulate air) filters.
-          airlocks and airshowers for personnel entering the cleanrooms


-          special protective clothing, shoes and cleaning equipment
 

-          equipment for cleanrooms is specially designed to generate low air contamination


-          positive pressure inside clenrooms to prevent entering air from outside if there are any leaks

 
According to GMP EU classification there are 4 classes of cleanrooms:
 

Maximum permissible concentration of particles in 1 m³ of air, the size of particles equals or exceeds the value in chart
Class under equipped conditions under working conditions
0.5 µm 5 µm 0.5 µm 5 µm
A 3500 0 3500 0
B 3500 0 350000 2000
C 350000 2000 3500000 20000
D 3500000 20000 n/a n/a

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