An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot.
Cleanrooms By United produces fully functional ISO 7 cleanrooms that meet all required specifications and requirements. We provide the layout, square footage, and features that your project specifications require. The custom, flexible, modular construction of our ISO 7 clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs evolve.
Contact us for more information regarding our ISO 7 clean room options 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 premium grade, high-efficiency ISO 7 clean rooms.
ISO 7 Cleanroom Standards
Classification for cleanrooms ranges 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. ISO class 7 clean rooms were previously defined under US Federal Standard 209E but are now defined under ISO 14644-1, 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 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 7 Cleanrooms
(FED STD 209E Equivalent: Class 10,000)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥1µm||≥5 µm|
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 10,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 7)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥5 µm|
ISO 7 Cleanroom Protective Requirements
Class 10,000 cleanrooms require workers to wear fewer protective garments than cleanrooms with a lower classification but still require the use of cleanroom clothing such as face masks, hair and beard covers, and lab coats or other frocks to cover street clothing. In some ISO7 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.
Depending on industry and application requirements, other precautionary measures may be taken to control particle count in an ISO 7 cleanroom environment. Sticky mats are often placed outside of 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 with a cleanroom professional for assistance in selecting the design and classification that are best suited for your application. Common ISO 7 clean room requirements include:
- Product pass throughs
- HEPA fan filters
- Heat welded vinyl or epoxy floors
- Gowning atrium
- Air locks
- Air conditioners
- Entrance and exit sticky mats
- Sealed lighting
- Bunny suit, booties, and hood requirements
- Stainless steel bench and hands free sink
How to Determine the Correct Cleanroom Classification Based on Your Needs?
A typical cleanroom is designed to keep outside contaminants and particles at a minimum based on the ISO clean room standards. Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, the two things that can introduce particles and contamination into your cleanroom are people and processes.
Classification for cleanrooms ranges 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 lower the ISO class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class.
As an example, Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot. The chart below provides an explanation of the differences between our clean room classes.
ISO 7 Cleanroom Applications
ISO 7 clean rooms provide air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot and a minimum of 60 air changes per hour. Industries that utilize ISO 7 cleanrooms include:
- Medical device manufacturing
- Electronics manufacturing
- Pharmaceutical compounding
- Aerospace product development
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Cleanrooms By United is your trusted source for premium grade, high-efficiency ISO 7 cleanrooms.