Clean Room Air Shower

Cleanroom Service: Design, Build and Install. Clean Room Equipment and Supplies: Modular Clean Room, Air Shower

ISO Cleanroom Classification Specifications

Cleanrooms are classified by how clean the air is. In Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5µm is measured in one cubic foot of air, and this count is used to classify the cleanroom.Pharmacy Cleanroom

ISO Cleanroom Classification Specifications

ISO 5 is a super clean cleanroom classification. A cleanroom must have less than 3,520 particles >0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour. The equivalent FED standard is class 100 or 100 particles per cubic foot. Common applications are semiconductor manufacturing and pharmaceutical filling rooms.Microelectronics Cleanroom


ISO 6 is a very clean cleanroom classification. A cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. The equivalent FED standard is class 1000 or 1000 particles per cubic foot.Food Germ-Free Cleanroom


ISO 7 is a common clean cleanroom classification. A cleanroom must have less than 352,000 particles >0.5 micron per cubic meter and 60HEPA filtered air changes per hour. The equivalent FED standard is class 10.000 or 10,000 particles per cubic foot. Common applications are pharmacy USP800 compounding rooms, electronics manufacturing and medical device manufacturing.Hospital Cleanroom


ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot. Common applications include plastic extrusion for medical devices, e-liquid manufacturing, and nutraceutical packaging.Printing Packaging Cleanroom


Cleanroom Testing and Certification


Once the Cleanroom is completed, most specifications call for testing and certification. Some requirements state that the clean room should be tested annually also. Testing is usually conducted by an independent testing agency using the ISO Standards.Blow Molding Film Cleanroom


ISO 14644-1:2015 Cleanroom Classification

This table details the air cleanliness class by particle concentration.
ISO Classification NumberMaximum allowable concentrations (particles/m3) for particles equal to and greater than the considered sizes, shown below
≥0.1µm≥0.2µm≥0.3µm≥0.5µm≥1µm≥5.0µm
ISO Class 110bdddde
ISO Class 210024b10bdde
ISO Class 31,00023710235bde
ISO Class 410,0002,3701,02035283be
ISO Class 5100,00023,70010,2003,520832d,e,f
ISO Class 61,000,000237,000102,00035,2008,320293
ISO Class 7ccc352,00083,2002,930
ISO Class 8ccc3,520,000832,00029,300
ISO Class 9gccc35,200,0008,320,000293,000
For cleanrooms and clean zones shown in ISO 14644-1:2015
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