ISO 8 Cleanrooms
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.
Cleanrooms By United produces technologically advanced ISO 8 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 8 clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs evolve.
Contact us for more information regarding our ISO 8 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 premier source for high-efficiency ISO 8 clean rooms.
ISO 8 Cleanroom Standards
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. 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)
|≥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 100,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 8)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥5 µm|
ISO 8 Cleanroom Particle Specifications
ISO 8 clean rooms do not require certain particle sizes to be tested, either because concentration levels are too high or low to be tested, but it cannot be zero. For ISO Class 8, particles smaller than 0.5 µm aren’t considered. The concentration of particles that are ≥0.5 µm should be below 3,520,000.
ISO 8 Cleanroom Protective Requirements
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
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, 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. The chart below provides an explanation of the differences between our clean room types.
ISO 8 Cleanroom Applications
ISO 8 clean rooms provide air cleanliness levels of a maximum of 100,000 particles (≥0.5 um) per cubic foot of interior air and a minimum of 20 air exchanges per hour. Applications include:
- Medical device manufacturing
- Electronics manufacturing
- Pharmaceutical compounding
- Aerospace product development
Contact Cleanrooms By United for ISO 8 Cleanrooms Today
Contact us for more information regarding our ISO 8 clean room options, or call us at 800-959-0878 and we will gladly discuss your project’s specification needs. Cleanrooms By United is your trusted source for technologically advanced, high-efficiency ISO 8 cleanrooms.