American Cleanroom Systems® Presents Cleanroom Classifications
American Cleanroom Systems is a full-service manufacturer, specializing in the rapid production and installation of superior quality custom Pharmaceutical, Medical and Industrial cleanrooms.
Our team can design, manufacture and install your certified cleanroom in as little as 4 weeks, on-site with minimum disruption.
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View FAQs about Cleanroom Classifications
US FED STD 209E
| Class | Maximum Particles/ft³ | ISO equivalent | ||||
| >0.1 um | >0.2 um | >0.3 um | >0.5 um | >5 um | ||
| 1 | 35 | 7 | 3 | 1 | ISO3 | |
| 10 | 350 | 75 | 30 | 10 | ISO4 | |
| 100 | 100 | ISO5 | ||||
| 1000 | 1000 | 7 | ISO6 | |||
| 10,000 | 10,000 | 70 | ISO7 | |||
| 100,000 | 100,000 | 700 | ISO8 | |||
ISO 14644-1 Cleanroom Standards
| Class | Maximum Particles/m³ | FED STD 209E equivalent | |||||
| >0.1 um | >0.2 um | >0.3 um | >0.5 um | >1 um | >5 um | ||
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class 1 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class 10 | |
| ISO 5 | 100,000 | 23,7000 | 102,000 | 3,520 | 8,320 | 293 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 2,930 | Class 1,000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | Room Air | |||
| Criteria | Class 10 ISO4 | Class 100 ISO5 | Class 1000 ISO6 | Class 10,000 ISO7 | Class 100,000 ISO8 |
| Air changes per HR/Min | 500-600 / 8 to 10 | 300 to 480 / 5 to 8 | 180 / 3 | 60 /1 | 20 /0.33 |
| Filter coverage % | 90 – 100 | 60 – 70 | 20 – 30 | 7 – 15 | 4 – 5 |
| CFM per square foot | 85 – 90 | 36 – 65 | 18 – 32 | 9 – 16 | 4 – 8 |
| Filter Efficiency | 99.9997% ULPAs | 99.997% HEPAs | 99.997% HEPAs | 99.997% HEPAs | 99.97% HEPAs |
| Ceiling Type | Aluminum T-bar grid | Aluminum T-bar grid | Aluminum T-bar grid | Conventional T-bar grid | Conventional T-bar grid |
| Light Fixture type | Tear drop or Flow thru | Tear drop or 2’x4’ cleanroom fixture | 2’x4’ cleanroom fixture | 2’x4’ cleanroom fixture | 2’x4’ standard fixture |
| Ceiling Panel | FRP, Vinyl rock or Mylar | FRP, Vinyl rock or Mylar | Vinyl rock or Mylar | Vinyl rock or Mylar | Vinyl rock or Mylar |
| Wall System | Modular or standard built | Modular or standard built | Modular or standard built | Modular or drywall | Modular or drywall |
| Flooring cover | Welded sheet vinyl or Epoxy | Welded sheet vinyl or Epoxy | Welded Sheet vinyl or Epoxy | Sheet vinyl or VCT | Sheet vinyl or VCT |
| Flooring base | 2” to 6” cove | Cove or Aluminum base channel | Cove or Aluminum base channel | Cove or Aluminum base channel | Cove or Aluminum base channel |
| Air Returns | Raised floor or center returns | Low wall on long axis | Low wall at perimeter | Low wall | Low wall or ceiling |
Why American Cleanroom Systems®
Experienced: Expert modular cleanroom design, manufacturing, installation and certification since 1976. More than 500 cleanrooms built.
Quality Construction: We manufacture all our components in house. Installation is done by our factory team on-site.
Satisfied Customers: Read why customers chose American Cleanroom Systems and why they come back.
FAQs About Cleanroom Classifications
What Is a Cleanroom?
A cleanroom (or clean room) is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. The FDA mandates the use of cleanrooms to create GMP manufacturing factories.
What Are Cleanrooms Used For?
Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. Cleanrooms use HEPA filters to remove particles from the air.
How Clean Is a Cleanroom?
Very clean. A class 100 cleanroom has 100 particles per cubic foot. By comparison your typical office space has between 500,000 and 1 million particles per cubic foot. Cleanrooms come in different classes from class 100 to 100,000.
When Is a Cleanroom Required?
Medical device and pharmaceutical manufacturing requires sterile environments to produce their products. Cleanrooms provide this sterile super clean manufacturing space which reduces the chance of contamination getting in your medicine. Semiconductor manufacturers produce devices with ultra small super dense features. Examples are computer chips for your cell phone or PC. If contamination were to get on the chip during manufacturing, they would not work.
What Are the Do and Don’ts in a Cleanroom?
Do:
- Do wipe down all surfaces on a regular basis to remove contamination.
- Do make sure doors are always closed to maintain positive pressure.
- Do always have all staff were cleanroom suits over their street clothes to prevent bringing contamination into the cleanroom.
Don’t:
- Don’t eat or drink in your cleanroom.
- Don’t bring dirty equipment or material into cleanroom – always wipe it down before bringing it in.
- Don’t turn off the HEPA fan filter units – it will take several hours after you turn them back on before the cleanroom is clean again.
ISO Cleanroom 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.
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.
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.
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.
