What ISO Cleanroom Classification Do I Need?

Cleanroom with exterior gowning room

What ISO Cleanroom Classification Do I Need?

Modular portable cleanroom systems provide advanced cleanroom solutions for your manufacturing constraints. Depending on your specifications, a modular cleanroom can be designed to handle your project’s exact particulate level requirements. Whether you require an ISO level 5, 6, 7, 8, or 9 prefab cleanroom for your particular application needs, Cleanrooms By United has you covered.

At Cleanrooms by United, we offer complete design to best accommodate the available square footage and features that your project requires. Our portable cleanrooms' custom, flexible, modular construction makes them easy to expand, reconfigure, or relocate as your cleanroom needs progress.

Determining the required ISO cleanroom classification is essential in selecting the right solution for your facility. Key considerations when deciding the ISO cleanroom standards for your application include:

  • What are the sources of contamination in my location?
  • How small are the smallest particles I need to remove from the air?
  • How much air do I need to circulate to remove contaminants?

Contact us for more information regarding your modular cleanroom design requirements, or call us at 800-959-0878, and we will gladly answer any questions that you may have. Cleanrooms By United is your trusted source for technologically advanced, high-efficiency ISO 14644-1 compliant clean rooms (Class 9 to Class 5).

Cleanroom Classes Defined

ISO cleanroom classifications are determined by the cleanliness of the air within the controlled environment. With your cleanroom manufactured to your needs, we can produce a modular solution meeting ISO cleanroom standards from Class 9 to Class 5. Our capabilities can offer the following ISO classifications:

  • ISO 5 cleanrooms: This classification is exceptionally clean, featuring less than 3,520 particles >0.5 microns per cubic meter and requiring 250-300 HEPA-filtered air changes per hour. ISO 5 cleanrooms are ideal for semiconductor manufacturing and pharmaceutical production.
  • ISO 6 cleanrooms: Cleanrooms with this classification are cleaner than ISO 7 and 8. They require less than 35,200 particles >0.5 microns per cubic meter and 180 HEPA-filtered air changes per hour.
  • ISO 7 cleanrooms: A common cleanroom classification, ISO 7 calls for less than 352,000 particles >0.5 microns per cubic meter and 60 HEPA-filtered air changes. This classification supports electronics and medical device manufacturing.
  • ISO 8 cleanrooms: Offering the least strict requirements, this classification must have less than 35,200,000 particles >0.5 microns per cubic meter and 20 HEPA-filtered air changes per hour. ISO 8 cleanrooms are well suited for medical device plastic extrusion, e-liquid manufacturing, and nutraceutical packaging.

ISO 14644-1 Modular Clean Room Classifications

Cleanrooms By United provides ISO Class 5 (Class 100) through ISO Class 9 (ambient) cleanrooms. Particle count is measured at work surface height.

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 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 Class1,000
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

What are the ISO Cleanroom Standards?

Criteria Class 100
ISO5
Class 1000
ISO6
Class 10,000
ISO7
Class 100,000
ISO8
Air changes per HR/Min 300 to 480 / 5 to 8 180 / 3 60 /1 20 /0.33
Filter coverage % 60 – 70 20 – 30 7 – 15 4  – 5
CFM per square foot 36 – 65 18 – 32 9 – 16 4 – 8
Filter Efficiency 99.997% HEPAs 99.997% HEPAs 99.997% HEPAs 99.97% HEPAs
Ceiling Type Aluminum T-bar grid Aluminum T-bar grid Conventional T-bar grid Conventional T-bar grid
Light Fixture type 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 Vinyl rock or Mylar Vinyl rock or Mylar Vinyl rock or Mylar
Wall System Modular Modular Modular Modular
Flooring cover Welded sheet vinyl or Epoxy Welded Sheet vinyl or Epoxy Sheet vinyl or VCT Sheet vinyl or VCT
Flooring base Cove or Aluminum base channel Cove or Aluminum base channel Cove or Aluminum base channel Cove or Aluminum base channel
Air Returns Low wall on long axis Low wall at perimeter Low wall Low wall or ceiling

Common Modular Cleanroom Options

We can produce various modular cleanroom solutions to your exact specifications. Learn more about our prefabricated modular cleanroom configurations, including:

Iso 7 Cleanroom with Technicians

What are Clean Rooms used for?

Customized hard wall cleanrooms can be manufactured to fit any dimensions and with unique special features that deliver the performance you need. Since they are completely customizable, modular clean rooms provide a higher level of design flexibility than standard drywall constructed cleanrooms. Some of the industries that regularly utilize prefab cleanrooms include:

Contact Cleanrooms by United for High-Quality Modular Cleanroom Solutions

Cleanrooms by United is your trusted ISO cleanroom manufacturer, offering advanced quality in your prefab cleanroom solutions. Contact us today for more information regarding our portable cleanroom solutions and your design requirements, or request a quote to begin.