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 5||Grade B||100000||23700||10200||3520||832||29|
|Class 7||Grade C||352000||83200||2930|
|Class 8||Grade D||3520000||832000||29300|
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|
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