What Are the Different ISO Classification Standards for Cleanrooms?


Cleanrooms are used in various industries, from hospitals and pharmaceuticals to aerospace. They’re designed to provide a sterile environment for various purposes. The classification of a cleanroom is essential for many reasons. It helps determine the environmental control you will have in the cleanroom. 

Moreover, carrying out different operations in the cleanrooms requires different ISO classifications. For instance, developing drugs requires a minimum of ISO 7 to prevent contamination.

Let’s take a look at different cleanroom classifications and their uses.

Why Are Cleanroom Classifications Required?

Cleanroom classifications are used to ensure the cleanliness of a cleanroom. These classifications aim to ensure that the cleanroom has been cleaned thoroughly, correctly, and effectively.

Classification standards are required by ISO 14644-1:2018 and ISO 14644-2:2018 for medical devices and food processing environments. Since many industries, including pharmaceuticals, food, manufacturing, semiconductors, etc., require a controlled environment, there is an increasing demand for cleanrooms. Hence, the global cleanroom technology market size is expected to grow at a CAGR of 5.4% between 2021 to 2028.

ISO 9 Cleanrooms

ISO 9 cleanrooms are the most stringent of all cleanroom classification standards. They are used for medical, pharmaceutical, and biotechnology applications, research, and development. 

ISO 9 cleanrooms are also used to manufacture electronic components, computers, and other high-tech equipment. Cleanrooms can also be found in food processing facilities, where they protect against biological contaminants that may affect product quality.

They are used in various industries, such as medical device manufacturing, pharmaceuticals, electronics, and aerospace. In the medical device industry, ISO 9 cleanrooms can help manufacture items such as syringes, implants, and other medical products. 

Syringes made without the help of cleanrooms can have particulate matter. These syringes with particulate matter can be hazardous when used for intravitreal injections.

In the pharmaceutical industry, they are used to produce drugs and other products that require a sterile environment. The electronics industry manufactures computer chips and other components that require a spotless environment. 

In the aerospace industry, they are used to build spacecraft components, such as engines and other parts, that must be free of contaminants. ISO 9 cleanrooms are also used in research laboratories, providing a sterile environment for experiments and tests.

ISO 8 Cleanrooms

ISO 8 cleanrooms are used to manufacture pharmaceuticals, biotechnology, and medical devices. ISO 8 cleanrooms are used in manufacturing operations where particulate contamination is a concern. The classification is based on the level of particulate contamination that can be tolerated in the air. Particulates can come from many sources, including dust, pollen, mold spores, bacteria, and viruses.

Like ISO 9, even ISO 8 cleanrooms can help with different industrial applications. You can use them for plastic injection molding, food packaging and processing, medical device manufacturing, drug development, etc.

The use of cleanrooms, especially those with high environmental control, like ISO 8 or ISO 9, in the food industry can be very beneficial. For instance, the WHO states that around 600 million people fall sick after consuming contaminated food. Using ISO 8 cleanrooms can reduce the chances of food contamination and ensure optimal food quality.

ISO 7 Cleanrooms

The ISO 7 standard is a classification of cleanrooms used in manufacturing pharmaceuticals, medical devices, and other products that require strict control over contamination by particles and aerosols. The standard specifies a maximum allowable level of contamination.

ISO 7 cleanrooms are designed to reduce particulate counts to nearly zero or below while maintaining consistent air quality within the class. Particles such as dust and dirt can damage sensitive production equipment like injection molding machines, which can be expensive to repair or replace if damaged by particles that fall into them. 

A cleanroom ensures that all equipment is protected from dust buildup, so it doesn’t get damaged during use. The ISO 7 cleanrooms must have less than 352,000 particles > 0.5 microns per cubic meter. These cleanrooms are recommended for applications requiring moderate particle concentration limits.

ISO 6 Cleanrooms

ISO 6 cleanrooms are the most stringent and have a high degree of contamination control. These rooms are often used for manufacturing semiconductors, photolithography, and biotechnology processes.

Achieving an ISO 6 classification is no easy feat. It involves rigorous testing to ensure that all particulate matter, including bacteria and viruses, is below specific levels. The ISO 6 cleanrooms require a limit of 35,200 particles > 0.5 microns per cubic meter. Also, it should be less than 8,320 particles > 1 micron per cubic meter.

ISO 5 Cleanrooms

ISO 5 cleanrooms are used for critical processes involving highly sensitive materials. A typical ISO 5 room uses a laminar airflow system to achieve its low particle count. The air enters through HEPA filters at the ceiling level and travels in parallel streams past all points of contamination until it exits through HEPA filters at the floor level.

It then passes through HEPA filters before being exhausted outside the building through ductwork or ventilators located at each wall panel of your room. These cleanrooms should have a limit of fewer than 3,520 particles > 0.5 microns per cubic meter.

ISO 4, ISO 3, ISO 2, ISO 1 Cleanrooms

Starting here, ISO 4, ISO 3, ISO 2, and ISO 1 cleanrooms have very high cleanliness efficiency requirements. There is an extensive range of applications for ISO 4 cleanrooms. All of these applications require equipment that must be held to strict standards to ensure that there aren’t any contaminants being introduced into the product being manufactured.

ISO 4 cleanrooms allow less than 352 particles per 0.5 microns per cubic meter. On the other hand, ISO 3, ISO 2, and ISO 1 cleanrooms only allow 35, 4, and 0 particles per 0.5 microns per cubic meter. Thus, ISO 1 is the cleanest cleanroom, and ISO 9 is the dirtiest.


So, what does all this mean for you? If you’re designing and building a cleanroom, you have many options. For example, choose an ISO Level 1 if your facility is small and has no need for specialized equipment. On the other hand, an ISO Level 8 would be appropriate if you have a large facility with lots of specialized equipment that needs frequent cleaning throughout the day.

While each level has its requirements, they all fall under one main category, maintaining cleanliness within controlled environments where work processes require low levels of contamination from outside sources such as dust particles or other contaminants like bacteria or viruses.

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