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 cleanrooms 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 and are commonly used as a “spot clean” enclosure within an already controlled environment.
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 additional cleanroom 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
Hard-walled Modular Cleanroom Advantages
Due to their ease of maintenance and simple installation methods, hard-walled modular cleanrooms are increasing in popularity in numerous industries across the globe. Since they can be installed quickly and easily and can be modified or even relocated with minimal expense and downtime. Many prefabricated modular cleanrooms are almost 100% reusable. Some additional benefits of a hard-walled modular cleanroom include:
- Less expensive than sheetrock construction
- Easily installed in days, not weeks
- Factory-cut options, with numerous custom 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 for reduced contamination from personnel and materials
Flexible & Affordable Modular Cleanroom Systems
Since they are constructed of hard or soft panels with a hard ceiling, modular cleanroom systems are highly configurable. 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. Hard-walled cleanrooms are fully enclosed and can be fitted with doors, windows, and transfer hatches, just like a permanent cleanroom.
Some of the advantages modular cleanroom systems provide over permanent clean rooms include:
- Versatility: A modular cleanrooms 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, retrofit, and/or upgraded.
- Cost-effective: Modular cleanrooms are designed and manufactured offsite for a fraction of the cost of permanent construction.
- Time Saving: Modular cleanroom systems can be installed onsite in a fraction of the time as permanent construction.
- Reduced downtime: Modular cleanroom installation causes far less disruption to daily operations, allowing many users to keep some or all operations running without disruption.
- Leasing: If you lease your space, the modular option allows you to uninstall the clean room you need and take it with you if your operation changes locations.
- R.O.I.: Because it can be taken down, moved, and re-erected, a modular cleanroom is considered a piece of capital equipment and can be treated as such for taxation purposes.
- Cleanliness: A modular cleanroom is the better option for cleanroom requirements above ISO 6 classification. The materials used in these systems do not shed like drywall or metal studs, reducing the level of contamination.
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
- Cosmetics and Bottling lines
- Aerospace product development
Learn About 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. Discover how Cleanrooms By United added an ISO 8 gowning room to a medical device cleanroom.