Clean Room Classifications

ISO 14644-1 Standards for Cleanrooms
Classmaximum particles / m3FED STD 209E
≥0.1 µm≥0.2 µm≥0.3 µm≥0.5 µm≥1 µm≥1 µm
ISO 1102.371.020.350.0830.0029(additional features required)
ISO 210023.710.23.50.830.029(additional features required)
ISO 31,000237102358.30.29Class 1
ISO 410,0002,3701,020352832.9Class 10
ISO 5100,00023,70010,2003,52083229Class 100
ISO 61.0 x 106237,000102,00035,2008,320293Class 1000
ISO 71.0 x 1072.37 x 1061,020,000352,00083,2002,930Class 10,000
ISO 81.0 x 1082.37 x 1071.02 x 1073,520,000832,00029,300Class 100,000
ISO 91.0 x 1092.37 x 1081.02 x 10835,200,0008,320,000293,000Room Air

The International Standards Organisation (ISO) has a 1 to 9 ranking system for cleanrooms, with 1 being the highest standard of cleanroom. The rating is based on the number of airborne particles per m3 and the particle sizes.

A cutting edge, sensitive pharmaceutical production facility may require an ISO 3 (Class 1) high specification cleanroom to meet the strict industry regulations whereas in medical packaging the cleanroom may only need to be ISO 7 classification (Class 10,000).

Puracore® cleanrooms have been designed and can be customised to each individual order to meet the standard and classification required.