Cleanroom Classification

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Cleanroom Classification

ISO 14644-1 cleanroom standards

Classmaximum particles/m3FED STD 209E
equivalent
≥0.1 µm≥0.2 µm≥0.3 µm≥0.5 µm≥1 µm≥5 µm
ISO 1102.371.020.350.0830.0029
ISO 210023.710.23.50.830.029
ISO 31,000237102358.30.29Class 1
ISO 410,0002,3701,020352832.9Class 10
ISO 5100,00023,70010,2003,52083229Class 100
ISO 61.0×106237,000102,00035,2008,320293Class 1,000
ISO 71.0×1072.37×1061,020,000352,00083,2002,930Class 10,000
ISO 81.0×1082.37×1071.02×1073,520,000832,00029,300Class 100,000
ISO 91.0×1092.37×1081.02×10835,200,0008,320,000293,000Room air

 

 

US FED STD 209E cleanroom standards

Classmaximum particles/ft3ISO
equivalent
≥0.1 µm≥0.2 µm≥0.3 µm≥0.5 µm≥5 µm
1357.5310.007ISO 3
103507530100.07ISO 4
1003,5007503001000.7ISO 5
1,00035,0007,50030001,0007ISO 6
10,000350,00075,00030,00010,00070ISO 7
100,0003.5×106750,000300,000100,000700ISO 8

 

 

GMP EU cleanroom classification

EU GMP guidelines are more stringent than others, requiring the cleanroom to meet particle counts at operation (during manufacturing process) and at rest (when manufacturing process is not carried out, but room AHU is on).

Classmaximum particles/m3
At RestAt RestIn OperationIn Operation
0.5 µm5 µm0.5 µm5 µm
Grade A3,50003,5000
Grade B3,5000350,0002,000
Grade C350,0002,0003,500,00020,000
Grade D3,520,00029,000n/an/a