ISO 8 Cleanrooms (Class 100,000 Cleanrooms)
Modular cleanrooms are controlled environments with extremely low levels of airborne contaminants. They are used by industries including laboratory, biotech, electronics, aerospace and several others for a range of testing, manufacturing and packaging applications.
Cleanrooms are classified based on the maximum number of particles allowed per cubic meter or cubic foot of interior air, with ISO 1 cleanrooms being the “cleanest” and ISO 9 cleanrooms being the “dirtiest.” The level of air cleanliness required depends on the industry and application. Laboratories and medical device manufacturing operations, for example, typically require a higher level of cleanliness than a cleanroom being used for automotive applications.
ISO 8 cleanrooms, also known as Class 100,000 cleanrooms, can be modular or soft-walled and have a maximum particle count of 100,000 particles (≥0.5 um) per cubic foot of interior air. They are required to have HEPA filtration coverage over 4-5% of the area and provide a minimum of 20 air exchanges per hour with air flow rates of 4-8 CFM per square foot.
Cleanliness Standards for ISO 8 Cleanrooms
Contamination levels in ISO 8/Class 100,000 cleanrooms are measured by the concentration of particles in a cubic foot or meter of air. These levels are measured in microns and defined by the following standards:
- 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 8 Cleanrooms
(FED STD 209E Equivalent: Class 100,000)
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 100,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 8)
Important Considerations for Class 100,000 Cleanroom Design
There are different ISO 8 cleanroom designs, including modular and soft-sided cleanrooms. A modular cleanroom has hard-sided walls that provide complete floor-to-ceiling protection for a higher level of cleanliness. They are used for permanent and semi-permanent installations and can be configured to any size. Softwall cleanrooms are constructed of soft panels or strips and do not touch the floor. They are designed for portability and more temporary installations.
In addition to structure, there are other important considerations for usability and to ensure effective control contaminant levels. Incorporating air showers, pass-through chambers and other accessories into the cleanroom design may be required to help prevent contamination from entering the cleanroom environment. Lighting, filtration and temperature control are also extremely important.
Cleanroom design considerations and standard requirements vary depending on the industry and application. In general, primary considerations for designing a Class 100,000 cleanroom include:
- HEPA filtration requirements
- Air pressure requirements
- Humidity or temperature control requirements
- Number of personnel working in the area
- Static control requirements
- Maximum contaminant levels
- Sanitation requirements
- Number and type of windows and doorways
- Lighting and electrical needs
A cleanroom professional can help you create a modular cleanroom design that is the best fit for your application and in compliance with federal regulations.