What is an ISO-7 Cleanroom Classification?

Figure 1. ISO-7 electronics PCB manufacturing modular cleanroom

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ISO-7 cleanroom classification is a common medium level of the cleanroom classes. The ISO cleanroom standards are set by the International Organization for Standardization (https://www.iso.org/standards.html). They are a private international organization with a membership of 167 national standards bodies. The ISO cleanroom classification system used in the United States is primarily for pharmaceutical cleanrooms, medical device cleanrooms, biotech cleanrooms, life-science cleanrooms, and  USP797/800 compounding cleanrooms. Europe and the rest of world uses the ISO cleanroom classification system for all industries except semiconductor.

ISO-7 cleanrooms are required to have 60 air changes per hour of HEPA filtered air and less than 2,930 particles/meter3 greater or equal to 5 microns. By comparison, a conditioned office space (non-cleanroom space) would have more than 100X as many particles per meter3. ISO-7 cleanroom classification also has requirements for >0.5 micron and >1 micron size particles (see table 1).

Table 1. FED STD 209E Cleanroom Classifications

There is a separate FED 209E cleanroom classification system that has been historically used in the United States for industrial cleanrooms such as semiconductor cleanrooms and printed circuit board cleanrooms. The ISO cleanroom classification is on a metric system (particles per meter3). The FED 209E cleanroom classification system is based on imperial system (particles per feet3). There are comparable ISO and FED 209E cleanroom classes for each level of cleanliness. An ISO-7 cleanroom classification corresponds to FED 209E class 10k cleanroom classification (see table 2).

Table 2. FED STD 209E Cleanroom Classifications

Common Applications for ISO-7 Cleanroom Classification Rooms

• USP797/800 compounding pharmacy cleanroom
• Medical device manufacturing cleanroom
• Printed Circuit board manufacturing cleanroom
• Pharmaceutical solution preparation cleanroom
• Pharmaceutical cream and ointment manufacturing cleanroom
• Pharmaceutical liquid manufacturing cleanroom
• CBD extraction cleanroom
• Laser cleanroom
• Precision manufacturing cleanroom
• Aerospace composite repair cleanroom
• Semiconductor test and packaging cleanroom
• R&D cleanroom

Figure 2. ISO-7 USP797/800 compounding pharmacy cleanroom

Figure 3. ISO-7 semiconductor test cleanroom

There are three different types of ISO-7 classification cleanrooms. They can be a modular cleanroom, a stick built (gypboard on studs) cleanroom or a softwall cleanroom. A modular cleanroom has advantage of fast install, easily modified or disassembled and moved to alternative site and can be upgraded to higher cleanroom classification such as ISO-6. A stick-built ISO-7 classification cleanroom requires the gypboard walls to be painted with epoxy paint. The cost can be slightly cheaper than modular but it takes significantly longer to build and is difficult to modify. A softwall ISO-7 classification cleanroom must be one pass so it cannot incorporate air conditioning. The stick-built cleanroom cost is similar to a modular cleanroom.

Figure 4. Air Flow simulation for ISO-7 recirculating modular cleanroom

Filtration for ISO-7 classification cleanrooms

Filtration for ISO-7 cleanrooms are done with HEPA filters. The best modular cleanroom design uses a negative pressure plenum with HEPA fan filter units in the ceiling and incorporated low wall air returns to achieve laminar air flow. The HEPA filtered air sweeps dirt down to the floor and horizontally to the low wall air returns.

The company is the world’s best class 7 cleanroom standards supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.

Cleanroom gowning for ISO-7 classification cleanrooms

Typically, cleanroom personnel wear cleanroom shoe covers to avoid tracking dirt into the cleanroom. Cleanroom head covering can be a cleanroom bouffant or cleanroom hood. Finally, they wear clean room jackets extending down to operator&#;s knees. All the garments are manufactured from special non-particulating cleanroom approved materials. Options include disposable or washable (you send back to cleanroom laundry) garments. The cleanroom shoe covers and bouffant caps are typically disposable. It is critical that the personnel wear cleanroom garments if user wants to maintain ISO-7 cleanroom classification.

Why gown room/airlock for ISO-7 classification cleanroom?

Because an ISO-7 classification cleanroom does 60 air changes per hour, if a door is even briefly opened to the dirty exterior it can take 10 to 15 minutes for the room to restore to class. The gown room/airlock will have HEPA filtration so the recovery time is typically reduced to under 5 minutes. Gown room / airlocks are a critical part of your ISO-7 classification cleanroom.

Property American Cleanroom Systems

The author Anthony Chien has worked at American Cleanroom Systems for the past 10 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design-build modular cleanroom manufacturer based in Rancho Santa Margarita CA. American Cleanroom Systems is your expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.

What Is an ISO Class 7 Cleanroom?

An ISO Class 7 cleanroom is a controlled environment that adheres to specific cleanliness standards defined by the International Organization for Standardization (ISO). Cleanrooms are essential in industries where the presence of contaminants, such as dust, microbes, or particles, can compromise the quality and integrity of products, processes, or research. The ISO standards classify cleanrooms on a scale ranging from ISO Class 1 (most stringent) to ISO Class 9 (least stringent), based on the allowable particle count within the cleanroom environment.

For an ISO Class 7 cleanroom:

• Particle Count: The ISO Class 7 standard specifies the maximum allowable particle count per cubic meter of air for particles equal to or larger than 0.5 micrometers. In the case of an ISO Class 7 cleanroom, the permissible particle count is limited to 352,000 particles per cubic meter.
• Air Quality: ISO Class 7 cleanrooms require high-efficiency air filtration systems, often utilizing HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filters. These filters effectively remove particles from the air, contributing to the cleanroom's controlled environment.
• Temperature and Humidity Control: Maintaining stable temperature and humidity levels is crucial in an ISO Class 7 cleanroom. Control over these factors helps prevent the generation of particles and ensures a consistent environment for sensitive processes.
• Personnel Garb and Procedures: Strict gowning procedures are implemented for personnel entering ISO Class 7 cleanrooms. This typically involves wearing specialized cleanroom suits, gloves, masks, and other protective gear to minimize the introduction of contaminants from outside sources.
• Cleanroom Design: The design and construction of ISO Class 7 cleanrooms involve careful consideration of materials and surfaces to minimize particle generation. Smooth, non-porous materials are used to create an environment that is easier to clean and less prone to contamination.
• Airflow Control: Positive air pressure is often maintained within the cleanroom to prevent the entry of external contaminants. The controlled airflow helps create a barrier, ensuring that particles are pushed out of the cleanroom rather than being drawn in.

ISO Class 7 cleanrooms find widespread application in industries such as pharmaceuticals, biotechnology, electronics, healthcare, aerospace, and other sectors where precision and cleanliness are critical for product quality and safety. The controlled environment provided by these cleanrooms is essential for processes where the slightest contamination can have significant consequences.

How Technical Safety Services Can Help You With Cleanroom Testing

Technical Safety Services is your one-stop shop for cleanroom certification services.

Our experts are experienced in conducting certification tasks, including: 

• Accurately assessing your facility&#;s airflow volume
• Testing the integrity of your HEPA filter system 
• Measuring non-viable airborne particulate levels
• Calculating room air exchange rate 
• Measuring room differential pressure 
• Measuring temperature and relative humidity 
• Conducting viable environmental monitoring 

To learn more about Technical Safety Services&#; approach to&#;cleanroom air monitoring&#;services, or to get started on a new project, please&#;contact us&#;today. 

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