Specification of Cleanrooms

The operation performed in the cleanroom will define what class or grade of cleanroom is required. Environmental monitoring allows the cleanroom to be assessed to the limits outlined in the following table to define the cleanroom grade or class. The assessment is based on air particle counts and microbial contamination of air and surfaces within the cleanroom.

The limits for air particle counts for the different cleanroom specifications are detailed below.

Maximum concentration limits ( Particles/m3 of air) (at rest)

ISO 14644 classification number GMP Orange guide 2014 0.1μm 0.2μm 0.3μm 0.5μm 1 μm 5μm
 Class 1  10 2
 Class 2  100  24  10  4
 Class 3  1000  237  102  35  8
 Class 4  10000  2370  1020  352  83
 Grade A  3520  20
 Class 5  Grade B  100000  23700  10200  3520  832  29
 Class 6  1000000  237000  102000  35200  8320  293
 Class 7  Grade C  352000  83200  2930
 Class 8  Grade D  3520000  832000  29300
 Class 9  35200000  832000  293000

Recommended limits for microbial contamination are detailed below

Grade Air Sample cfu/m3 Settle Plates(diam. 90 mm)cfu/4 hours Contact Plates(diam. 55mm)cfu/plate Glove Print 5 fingers Cfu/glove
 A  <1  <1  <1  <1
 B  10  5  5  5
 C  100  50  25  –
 D  200  100  50  –
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