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ISO 7 Cleanroom | Class 10000 Cleanroom ...

Author: Ingrid

Oct. 28, 2024

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Cleanroom Classifications 

ISO 7 Cleanrooms 

ISO 7 Cleanrooms

ISO 7 Cleanrooms

Understanding ISO Class 7 Cleanrooms

An ISO 7 cleanroom, also referred to as a Class 10,000 cleanroom, is a facility constructed with hard-sided modular walls that employs HEPA filtration systems. These systems maintain air cleanliness, allowing a maximum of 10,000 particles (≤0.5µm) per cubic foot. For a Class 10,000 cleanroom, the filtration systems must ensure 15-25% filter coverage and facilitate up to 60 air changes each hour. The defined air flow rate for an ISO 7 cleanroom's filtration system is typically between 9-16 CFM for every square foot.

At Cleanrooms by United, we manufacture fully functional ISO 7 cleanrooms tailored to your specifications. We provide precise layouts, square footage, and features that align with your project’s requirements. Our custom, flexible, and modular cleanroom construction allows easy expansion, reconfiguration, and relocation as your needs evolve.

For further details on our manufacturing options, please contact us at 800-959-. Our team is happy to assist with your inquiries.

Distinguishing Between ISO 7 and ISO 8 Cleanrooms

Cleanroom classifications range from ISO 1 to ISO 9, with ISO 9 as the least clean and ISO 1 as the most sterile environment. These classifications are based on the allowable concentration limit of particles per cubic foot or meter of air. The key differentiating factor between the cleanroom classes is the number of air changes per hour; ISO 7 cleanrooms typically have 30-60 air changes, whereas ISO 8 cleanrooms have about 10-25. Previously, ISO 7 was under the US Federal Standard 209E but has since been defined under ISO 14644-1. However, both standards are still commonly referenced.

  • US Federal Standard 209E: specifies the number of particles (≥0.5 µm) per cubic foot of air
  • ISO 14644-1: superseded standard 209E in 1999 but is still often cited, signifying the number of particles (≥0.1µm to ≥5µm) per cubic meter of air.

ISO 14644-1 Class 7: Permitted Maximum Particle Counts/m³

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

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

US FED Standard 209E Permitted Maximum Particles/ft³ for Class 10,000 Cleanrooms

(ISO 14644-1 Equivalent to ISO 7)

  • ≥0.1 µm : 350,000
  • ≥0.2 µm : 75,000
  • ≥0.3 µm : 30,000
  • ≥0.5µm : 10,000

Protective Gear for ISO 7 Cleanrooms

In Class 10,000 cleanrooms, staff members are required to wear fewer protective garments compared to lower-tier cleanrooms, but they still benefit from masks, hair covers, lab coats, and other garments to shield street clothes. In certain ISO 7 cleanrooms, full-body suits and gloves may be necessary as well. These garments are crafted from nonwoven textiles to avoid shedding fibers that could cause contamination. Gloves must be sterile and can be made from latex, nitrile, or other synthetic materials.

Discuss your needs regarding class 7 cleanroom standards with us. Our knowledgeable sales team will assist you in identifying the options that best meet your needs.

Additional precautions are implemented to maintain the allowed particle count of 352,000 per cubic meter, which may vary based on industry and application requirements. Commonly, sticky mats are placed outside cleanroom entrances to eliminate dirt and other contaminants from footwear. Pass-thru cabinets equipped with filtration systems may be utilized to transfer products safely while minimizing the number of individuals entering and exiting.

Cleanroom needs can vary greatly depending on industry regulations and the type of activities conducted. Selecting the right cleanroom design components and classification requirements is vital. Some typical requirements for ISO 7 cleanroom design components include:

  • Pass-thru cabinets, windows, and chambers
  • HEPA fan filter systems
  • Heat-welded vinyl or epoxy flooring
  • Gowning areas
  • Airlocks and conditioning systems
  • Sticky mats for entry and exit
  • Sealed lighting
  • Bun suits, booties, and hoods
  • Stainless steel workbenches
  • Hands-free sinks

Benefits of Class 10,000 Cleanrooms

Modular cleanrooms are favored for their ease of maintenance and installation, making them highly suitable for operations requiring contaminant-free environments across various industries. Once established, a standalone cleanroom remains free from external particles and can be reconfigured or relocated with little expense and downtime. Prefabricated modular cleanrooms are nearly 100% reusable, providing advantages for high-purity applications such as:

  • More cost-effective than sheetrock alternatives
  • Installation can be accomplished in days rather than weeks
  • Customizable and prefabricated modular designs
  • Pre-wiring with UL-Classified raceways
  • Choices for energy-efficient insulated walls
  • Dedicated anterooms and gowning spaces to minimize contamination
  • Air showers, airlocks, and pass-thru systems for reduced contamination from personnel and materials

ISO 7 Cleanroom Uses

Class 10,000 cleanrooms control particle cleanliness with a limit of 352,000 particles per cubic meter and 30 to 60 air changes per hour, facilitating particle-free operations. Industries and applications that utilize ISO 7 cleanrooms include:

Contact Cleanrooms by United for Class 10,000 Cleanrooms

Cleanrooms by United stands out as a reliable manufacturer of ISO 7 cleanrooms, providing high-efficiency solutions tailored to your needs. Discover how we efficiently established a manufacturing Class 10,000 cleanroom with minimal disruption in a facility.

For further discussion regarding your project, get in touch with Cleanrooms by United by calling 800-959- or request a quote to begin.

To learn more about cleanroom options, please explore our site at linear bar diffuser.

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