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Class 10000 Cleanrooms
Class 10000 Cleanrooms
What is a Class 10000 (ISO 7) Cleanroom?
An ISO 7 cleanroom, or Class 10000 cleanroom, is a hard-sided, modular wall facility that utilizes HEPA filtration systems to maintain air cleanliness levels with a maximum of 10,000 particles (≥0.5µm) per cubic foot. Class 10000 cleanroom filtration systems must provide filter coverage of 15-25% and a maximum of 60 air changes per hour. The standard air flow rate for an ISO 7 cleanroom filtration system is 9-16 CFM per square foot.
Cleanrooms by United produces a variety of cleanroom solutions for contaminant-free applications, including fully functional ISO 7 cleanrooms to meet requirements. We provide the layout, square footage, and features your project specifications need. Custom, flexible, modular cleanroom construction makes our Class 10000 cleanrooms easy to expand, reconfigure, and relocate as your needs evolve.
Contact us for more information on manufacturing options or call us at 888-949-6379. We will gladly answer your questions.
What are the Guidelines for ISO 7 Cleanroom Requirements?
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. The number of air changes per hour drives the main difference between cleanroom classes, where ISO 7 cleanrooms have 30-60 air changes per hour. They were previously defined under US Federal Standard 209E but are now defined under ISO 14664-1:
- US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air
- ISO 14644-1: replaced standard 209E in 2001 but is still used as a reference, which denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Class 7: Standard for Maximum Number of Particles Permitted/m3
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US FED Standard 209E Maximum Number of Particles Permitted/ft3 for Class 10000 Cleanrooms
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ISO 7 Cleanroom Requirements
Cleanrooms by United is your partner in cleanroom design and production, offering complete design services or engineering guidance for a cost-effective system that meets your requirements. Factory-engineered and made to your specifications for temperature, humidity, differential pressure, lighting, and noise levels, your cleanroom can be tailored to your exact needs, including solutions for types of doors, windows, wall panels, flooring, and much more.
We manufacture modular cleanroom designs with components that can be reconfigured to meet standards for ISO class 8 to ISO class 5 solutions. These prefabricated, panelized wall systems offer easy relocation, expansion, and modification with minimal expense for an almost entirely reusable, sustainable option that will not disrupt operations with traditional construction. Our case studies offer examples of how much customization can be achieved in your ISO 7 cleanroom.
Air Quality, Airflow, and Temperature Control
To meet the desired particle count of ISO 7 cleanrooms, our designs utilize high-efficiency air filtration and environmental control systems. HEPA and ULPA filters effectively remove particles to contribute to the controlled environment specifications for your operations. At the same time, positive air pressure is maintained within the cleanroom to prevent the introduction of contaminants into the environment, creating a barrier to push particles out rather than draw them in. The design of your ISO 7 cleanroom should also include temperature and humidity control systems to maintain a consistent environment for sensitive processes.
Contaminant Control Requirements
Various precautions may be taken to maintain the permissible maximum particle count of 352,000 per cubic meter, depending on the industry and application requirements. As requirements are based on the industry standards and processes being performed, it is essential to consult a cleanroom professional for assistance to select design requirements that are best suited to your application, including:
- Pass-thru windows, cabinets, and chambers
- HEPA fan filters
- Heat-welded vinyl or epoxy floors
- Gowning atrium
- Airlocks and conditioners
- Entrance and exit sticky mats
- Sealed lighting
- Stainless steel benches
- Hands-free sinks
Protective Gear for Personnel
Class 10000 cleanrooms require personnel to wear fewer protective garments than cleanrooms with a lower classification, but they still benefit from solutions that cover street clothing and prevent contamination. Cleanroom clothing is made from nonwoven fabrics to avoid contamination from shedding material fibers, including synthetic gloves for increased sterilization and sticky mats to remove dirt and other contaminants from shoes. ISO 7 cleanroom requirements for personnel include:
- Face masks, hair, and beard covers
- Lab coats, coveralls, or frocks
- Bunny suits, booties, and hoods
Advantages of Class 10000 Cleanrooms
Modular cleanrooms offer a range of benefits to spatial constraints in facilities or warehouses, making them highly popular for contaminant-free operations across various industries. They are easy to maintain and install, and once fully built, they offer an isolated, modular solution that is free from outside particles. Easily modified or relocated with minimal expense or downtime, prefabricated modular designs are nearly 100% reusable and provide operational advantages, such as:
- More cost-effective than traditional construction
- Fast installation in days, not weeks
- Prefabricated and custom modular solutions
- Pre-wired with UL-classified raceways
- Options for energy efficiency
- Customizations to lower contamination
See Our Expertise in Action: ISO 7 Manufacturing Cleanroom
Discover how we helped a manufacturer reduce contamination and improve product quality with a modular ISO 7 cleanroom. By sealing against the vacuum oven, adding a pass-through chamber, and providing insulated walls for temperature control, we created a clean, controlled environment without disrupting ongoing operations. This case study highlights how our modular cleanroom system improved efficiency and lowered rejection rates.
Read the full case study to see our ISO 7 cleanroom in action.
ISO 7 Cleanroom Applications
Class 10000 cleanrooms are designed to maintain air cleanliness levels with a maximum of 352,000 particles per cubic meter and 30 to 60 air changes per hour for particle-free facility operations. Cleanrooms by United manufactures cleanroom solutions for a range of applications and industries. With customizable design components to meet your specific cleanroom requirements, we provide ISO 7 cleanrooms for medical devices, pharmaceuticals, aerospace, automotive, and other contaminant-free operations.
Pharmaceutical Cleanrooms
Modular labs for pharmaceutical research, including batch mixing, blending labs, and gowning rooms, at any required ISO level.
Medical Device Cleanroom
Ensure a controlled environment for medical product manufacturing and assembly. Features include HEPA filtration, gowning areas, pass-thru chambers, and compliance with ISO 7 or stricter 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.
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.
Hardwall Cleanrooms
Flexible, cost-effective cleanrooms that assemble quickly and relocate easily. Includes windows, doors, flush mount electrical outlets and insulation for optimal control. Great for applications looking to expand in the future.
Contact Us for Class 10000 Cleanrooms Built to Your Requirements
As a trusted modular cleanroom manufacturer, Cleanrooms by United offers a range of flexible solutions built in compliance with ISO 14644-1 to meet regulatory requirements. With a range of cleanroom design components to choose from, we provide various functional and optional elements to customize your cleanroom solution to your exact process specifications. Working with you, we will design and engineer a Class 10000 cleanroom to the desired particle count of its classification for your application. Contact Cleanrooms by United to get started with your custom cleanroom design or request a quote to begin.