What is an ISO 8 Cleanroom?

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.

What are 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 Cleanrooms

ISO 8 Cleanrooms

ISO 8 cleanrooms, or Class 100,000 cleanrooms, can be modular hardwall or soft-walled with a maximum particle count of 100,000 particles (≥0.5µm) per cubic foot of interior air. They must have HEPA filtration coverage of 4-5% of the area and provide a minimum of 20 air exchanges per hour with flow rates of 4-8 CFM per square foot.

At Cleanrooms by United, we are a technologically advanced ISO 8 (class 100,000) cleanroom manufacturer. We can produce Class 100,000 cleanrooms to meet your desired specifications and requirements, including layout, square footage, and features. Our ISO 8 cleanrooms' custom, flexible, and modular construction makes them easy to expand, reconfigure, or relocate as your needs evolve.

Contact us for more information regarding our ISO 8 cleanroom options, or call us at 800-959-0878, and we will gladly answer any questions you may have.

Class 100,000 Cleanroom Operating Conditions

Cleanroom classifications range from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest”. All cleanrooms should fall within the standard temperature range of 70° F (20° C), with a 2-degree variance warmer or colder, but aerospace cleanrooms should fall between 67° F and 77° F (or 19° C to 25° C). These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. Contamination levels in ISO 8 cleanrooms have a maximum particle count of 100,000 particles per cubic foot of air, and require 20 air changes per hour of HEPA-filtered air to meet requirements.

US Federal Standard 209E: denotes the number of particles (≥0.5µm) 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 14664-1 Class 8: Standard for Maximum Number of Particles Permitted/m³

(FED STD 209 E Equivalent: Class 100,000)

≥0.1 µm	≥0.2 µm	≥0.3 µm	≥0.5µm	≥1µm	≥5 µm
—	—	—	3,520,000	832,000	29,300

US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 100,000 Cleanrooms

(ISO 14644-1 Equivalent to ISO 8)

≥0.1 µm	≥0.2 µm	≥0.3 µm	≥0.5µm	≥5 µm
—	750,000	300,000	100,000	70

ISO 8 Cleanroom Particle Specifications

Class 100,000 cleanrooms do not require some particle sizes to be tested. This happens because concentration levels are either too high or too low to be tested, but they cannot be zero. For ISO 8 cleanrooms, particles smaller than 0.5 µm aren’t considered. The concentration of particles that are ≥0.5 µm should be below 3,520,000.

Protective Requirements for ISO 8 Cleanrooms

There are different ISO 8 cleanroom designs, including modular hardwall and soft-sided cleanrooms. A modular cleanroom has hard-sided walls, providing 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 that do not touch the floor. They are designed for portability and temporary installations, which can be used as a “spot clean” enclosure within an already controlled environment.

In addition to structure, other considerations are necessary to ensure effective control of contaminant levels and usability. For example, air showers, pass-through chambers, and other cleanroom features may be required to help prevent contamination from entering the environment. Lighting, filtration, and temperature control are also crucial.

Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, people and processes can introduce particles and contamination into your cleanroom. Class 100,000 cleanroom design considerations and standard requirements vary depending on the industry and application. In general, primary considerations for designing an ISO 8 cleanroom include:

HEPA filtration requirements
Air pressure requirements
Humidity or temperature control requirements
Number of personnel working in the area
Static control requirements
Maximum containment levels
Sanitation requirements
Number and type of windows and doorways
Lighting and electrical needs

Advantages for Class 100,000 Cleanrooms

Due to maintenance ease and simple installation, hard-walled modular cleanrooms are increasingly popular in various industries. They can be installed quickly and easily, then modified or relocated with minimal expense and downtime. Many prefabricated modular cleanrooms are nearly 100% reusable. Additional benefits of hard-walled modular cleanroom are as follows:

Less expensive than sheetrock construction
Easily installed in days, not weeks
Factory-cut options and customized options
Pre-wired UL-Classified raceway installation capabilities
Insulated wall options for reduced energy costs
Anteroom and gowning room options for reduced contamination
Airlock, air shower, and pass-through box options reducing exposure for personnel and materials

Flexible & Affordable ISO 8 Cleanroom Design

Modular cleanroom systems are highly configurable because they are constructed with hard or soft panels and a hard ceiling. Soft-panel cleanrooms have walls made from clear PVC and one small opening for entering and exiting the area. Hard-panel systems consist of prefabricated panels that join to create a square or rectangular room. They are also fully enclosed and can be fitted with doors, windows, and transfer hatches, just like a permanent cleanroom. Opting for a modular cleanroom instead of a permanent cleanroom offers:

Versatility: A modular cleanroom can be readily assembled, disassembled, and relocated, often in just a few days or less.
Easily reconfigurable: The layout of a modular cleanroom can be rearranged, expanded, retrofitted, and upgraded.
Cost-effective: Modular cleanrooms are designed and manufactured offsite for a fraction of the cost of permanent construction.
Time-saving: Installing modular cleanrooms on site takes a fraction of the time as permanent construction.
Reduced downtime: Installation of modular cleanrooms causes less disruption to daily operations, allowing many users to keep some or all operations running.
Leasing: If you lease your space, modular cleanrooms allow for uninstallation when you need to take it with you when your location changes.
R.O.I.: Modular cleanrooms can be taken down, moved, and re-erected, which makes it a piece of capital equipment, and it can be treated as such for taxation purposes.
Cleanliness: For cleanroom requirements above ISO 6, modular cleanrooms are better than permanent constructions. The materials used in modular cleanrooms do not shed like drywall or metal studs, reducing contamination.

ISO 8 Cleanroom Case Study: Printer Enclosure & Modular Breakroom

See how we designed and installed a 25’ x 40’ ISO 8 printer enclosure with an attached modular breakroom to meet a client’s printing needs. By collaborating with the printer manufacturer, we created a clearspan enclosure to accommodate their large automated machine, ensuring positive pressure for contamination control. With city permits secured and a breakroom fully equipped for 20 employees, the entire system was installed and operational just three weeks after shipping.

Read the full case study to see our ISO 8 cleanroom in action.

View Case Study

Class 100,000 Cleanroom Industrial Applications

ISO 8 cleanrooms provide air cleanliness levels to a maximum of 100,000 particles (≥0.5µm) per cubic foot of interior air and a minimum of 20 air exchanges per hour. Some industrial applications may include:

Pharmaceutical Cleanrooms

Modular labs for pharmaceutical research, including batch mixing, blending labs, and gowning rooms, at any required ISO level.

CMM Enclosures

Provide precise environmental control for part testing and fabrication. Can include 22 ft. or taller walls, viewing windows, temperature regulation, and roll-up doors.

Automotive Cleanrooms

Maintain precision and contamination control in automotive manufacturing with modular cleanrooms. Features include HEPA filtration, pass-thrus, air showers, and customizable layouts to meet industry standards.

Aerospace Cleanrooms

Ensure precision manufacturing with aerospace cleanrooms designed to prevent contamination in sensitive components. Features include HEPA filtration, temperature and humidity control, air showers, and modular flexibility for easy installation and relocation.

Cosmetic Production Cleanrooms

Ensure contamination-free cosmetic manufacturing with modular cleanrooms designed for bottling and packaging. Features include HEPA filtration, ISO 22716 compliance, humidity control, and customizable layouts.

Contact Us for ISO 8 Cleanrooms that Meet Your Requirements

Contact Cleanrooms by United for more information regarding our ISO 8 cleanroom options. You can also reach our team at 800-959-0878 to discuss your project specification needs or request a quote to get started.

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