What is ISO 8 cleanroom classification?

Aug. 13, 2024

What is ISO 8 cleanroom classification?

An ISO -1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. Typically, these particles are dust, airborne microbes, aerosol particles, and chemical vapors. Beyond particle counts, cleanrooms often have controls for a number of other parameters like pressure, temperature, and humidity. Additionally, to be considered a cleanroom, the space needs High-Efficiency Particulate Air (HEPA) filters to remove particles from the air.

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ISO -1 Cleanrooms are classified from ISO 1 to ISO 9. Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification.

ISO 8 Cleanroom Standards

The allowed particle counts for an ISO 8 cleanroom depend on the referenced standard and its measurements. According to US Federal Standard 209E, ISO 8 cleanrooms are also known as Class 100,000 cleanrooms.

-08-10 ISO Cleanroom Standards

ISO -1 replaced the federal standard and states that an ISO 8 cleanroom needs less than 3,520,000 of &#; 0.5 micron sized particles per cubic meter of air. Only particles 0.5 microns or larger are measured in an ISO 8 cleanroom. This is done because the concentration of smaller particle sizes is too high.

ISO 8 Protective Requirements and Design Considerations

Designing a cleanroom requires taking additional regulatory standards and requirements into account based on industry and application. However, there are several general requirements and environmental parameters to consider for an ISO 8 cleanroom. For an ISO 8 Cleanroom, these include:

HEPA filtration
Air Changes per Hour (ACH)
Air pressure
Temperature and humidity
Amount of personnel working in the space
Static control
Lighting
Noise levels

Since an ISO 8 cleanroom is focused on measuring particles 0.5 microns or larger, the HEPA filtration system needs to be 99.97% efficient and a minimum of 20 air changes per hour is recommended. The final filtration of air occurs where the air enters the cleanroom. Additionally, it is most common for ISO 8 cleanrooms to employ non-unidirectional or mixed air flow patterns with low wall air returns. Common ISO 8 Applications

A wide variety of industries and applications have cleanrooms. Some of the most common with ISO 8 cleanrooms include:

Frequently Asked Questions on ISO 8

What is the difference between ISO 7 and ISO 8?

The two main differences between ISO 7 and ISO 8 cleanrooms are particle count and ACH requirements, which set them apart for differing applications. An ISO 7 cleanroom must have 352,000 particles &#; 0.5 microns per cubic meter and 60 ACH per hour as opposed to ISO 8&#;s 3,520,000 particles and 20 ACH.

When is a cleanroom required?

A cleanroom can be used for a number of industries and applications. They are required for spaces where cleanliness and sterility are crucial. For context, an ISO 8 cleanroom is usually 5-10 times cleaner than a typical office environment. Specifically, in medical device and pharmaceutical manufacturing cleanrooms, the safety and quality of products is of the utmost importance, and raw materials, manufacturing processes, and finished product and can be affected if too many particles enter the space.

Setra's CEMS for Cleanroom Environmental Monitoring

An environmental monitoring system is designed to gather, analyze, and notify on detailed cleanroom environmental data. For manufacturing spaces in particular, the goal of cleanroom monitoring is to assess the potential contamination risk of the product and remain in compliance with regulatory standards.

CEMS is Setra&#;s continuous environmental monitoring software that collects real-time data from in room cleanroom measurement sensors. Setra&#;s CEMS is a single system that can monitor a diverse facility with multiple locations, providing instant environmental data access and sophisticated analysis from a web-based interface accessible from any internet enables device. Real-time alarm notifications can be seen visually in software and sent to users via text message and . Instant, up-to-date reports and graphs provide easy access to proper documentation for regulatory requirements. Setra&#;s CEMS helps to continuously monitor an environment during the manufacturing process to simplify operations, minimize the risk of contamination, and improve the quality of products.

Medical device manufacturing
Pharmaceutical manufacturing and compounding
Semiconductor manufacturing
Electronics manufacturing

CEMS accepts data inputs from a variety of measurement sensors, including:cems and hardware with wireless

Temperature
Relative humidity
Pressure
Velocity (ACH)
Particle count
CO2
Door opens and count

CEMS helps cleanrooms meet all the necessary regulatory requirements for ISO , USP<797>, USP<800>, cGMP, EU Annex 1, GAMP, Joint Commission, FDA 21 CFR Part 11, EU Annex 11, and GAMP5. With simple networking and dependable remote access via the secure SetraCLOUD, users can save time and money with data exports and reporting features.

Are you interested in learning more about cleanroom iso 8? Contact us today to secure an expert consultation!

ISO 8 Cleanrooms | Class ...

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Cleanroom Classifications

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-, 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 -1: replaced federal standard 209E in 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 -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 -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.

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:

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- to discuss your project specification needs or request a quote to get started.

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