ISO 7 Cleanrooms

ISO 7 Cleanroom with gowning room and staging room

ISO 7 Cleanrooms

What is an ISO Class 7 Cleanroom?

An ISO 7 cleanroom, or Class 10000 cleanroom, is a hard-sided, modular wall facility that utilizes HEPA filtration systems to maintain air cleanliness levels with a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10000 cleanroom filtration systems must provide filter coverage of 15-25% and a maximum of 60 air changes per hour. The standard air flow rate for an ISO 7 cleanroom filtration system is 9-16 CFM per square foot.

Cleanrooms by United produces fully functional ISO 7 cleanrooms to meet requirements. We provide the layout, square footage, and features your project specifications need. Custom, flexible, modular cleanroom construction makes our Class 10000 cleanrooms easy to expand, reconfigure, and relocate as your needs evolve.

Contact us for more information on manufacturing options or call us at 800-959-0878. We will gladly answer your questions.

What is the Difference Between ISO 7 and ISO 8 Cleanrooms?

Cleanroom classifications range from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest”. These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. The number of air changes per hour drives the main difference between cleanroom classes. Class 7 cleanrooms have 30-60 air changes per hour, while Class 8 cleanrooms have 10-25 air changes per hour. ISO 7 cleanrooms were previously defined under US Federal Standard 209E but are now defined under ISO 14664-1. However, both are still regularly used as reference points.

  • US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air
  • ISO 1464-1: replaced standard 209E in 2001 but is still used as a reference, which denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.

ISO 14644-1 Class 7: Standard for Maximum Number of Particles Permitted/m³

(FED STD 209E Equivalent: Class 10,000)

≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5µm ≥1µm ≥5 µm
1,020,000 352,000 83,200 2,930

US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 10000 Cleanrooms

(ISO 14644-1 Equivalent to ISO 7)

≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5µm ≥5 µm
350,000 75,000 30,000 10,000 70

Protective Requirements for ISO 7 Cleanrooms

Class 10000 cleanrooms require personnel to wear fewer protective garments than cleanrooms with a lower classification but still benefit from face masks, hair and beard covers, lab coats, and other frocks to cover street clothing. In some ISO 7 cleanrooms, coveralls and gloves may also be required. Cleanroom clothing is made from nonwoven fabrics to prevent contamination from shedding material fibers. Gloves are sterile and made from latex, nitrile, or other synthetic materials.

Other precautions may be taken to maintain the permissible maximum particle count of 352,000 per cubic meter, depending on industry and application requirements. Sticky mats are often placed outside cleanroom entrances to remove dirt and other contaminants from shoes. Pass-thru cabinets fitted with filtration systems may also be used to safely transfer products while limiting the number of people entering and exiting the room.

Cleanroom requirements vary widely based on industry standards and the type of processes being performed. Always consult a cleanroom professional for assistance in selecting cleanroom design components and classification requirements best suited for your application. Common ISO 7 design component requirements include:

  • Pass-thru windows, cabinets, and chambers
  • HEPA fan filters
  • Heat-welded vinyl or epoxy floors
  • Gowning atrium
  • Air locks and conditioners
  • Entrance and exit sticky mats
  • Sealed lighting
  • Bunny suits, booties, and hoods
  • Stainless steel benches
  • Hands-free sinks

ISO 7 Cleanroom with Sink

Advantages of Class 10000 Cleanrooms

Modular cleanrooms are easy to maintain and install, which makes them highly popular for contaminant-free operations in various industries. Once fully built, an isolated cleanroom is free from outside particles and can be modified or relocated with minimal expenses and downtime. Prefabricated, modular cleanrooms are nearly 100% reusable, with benefits for high-purity applications, such as:

  • More cost-effective than sheetrock construction
  • Installed quickly in days, not weeks
  • Prefabricated and custom modular solutions
  • Can be pre-wired with UL-Classified raceways
  • Options for energy-efficient insulated walls
  • Anteroom and gowning rooms for reduced contamination
  • Air locks, air showers, and pass-thrus for lower contamination from personnel and materials

ISO 7 Cleanroom Applications

Class 10000 cleanrooms maintain air cleanliness levels with a maximum of 352,000 particles per cubic meter and 30 to 60 air changes per hour for particle-free facility operations. Applications and industries for ISO 7 cleanrooms include the following:

Contact Cleanrooms by United for Class 10000 Cleanrooms

Cleanrooms by United is a trusted ISO 7 cleanroom manufacturer with premium-grade, high-efficiency cleanroom solutions to meet your requirements. Learn how we solved a fast and minimal disruption set-up of a manufacturing Class 10000 cleanroom within a facility.

Contact Cleanrooms by United to discuss the needs of your project further by giving us a call at 800-959-0878 or request a quote to get started.