What is a Class 8 cleanroom?

ISO 14644 Cleanliness Class Standard

ISO 14644 is a family of standards for modular cleanrooms and related controlled environments developed by the International Organization for Standardization (ISO) to define and evaluate cleanliness levels for cleanrooms. According to the standard, cleanliness classes for cleanrooms range from ISO 1 to ISO 9, with smaller values indicating higher cleanliness. The following are the main cleanliness classes and their characteristics:

ISO 5
Cleanrooms of this class allow a maximum of 3,520 particles of 0.5 microns or larger per cubic meter of air. It is suitable for industries with extremely high cleanliness requirements such as semiconductor manufacturing, pharmaceuticals and biotechnology.
ISO 6
Up to 35,200 particles above 0.5 microns per cubic meter of air in ISO 6 class. It is suitable for the production of microelectronic and optical equipment, where strict control of airborne particles is still required, albeit at a slightly lower level of cleanliness.
ISO 7
The ISO 7 standard allows for a maximum of 352,000 particles of 0.5 microns or larger per cubic meter of air. This class is generally used in the production of pharmaceuticals, the manufacture of medical devices and other fields where control of cleanliness is still very important.
ISO 8
In this class, a maximum of 2,832,000 particles above 0.5 micron per cubic meter of air are allowed, and it is suitable for industries with less stringent cleanliness requirements than ISO 7, such as certain food processing and light industries.

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What is a ISO 8 Cleanroom?

A ISO 8 cleanroom is a controlled environment in which no more than 2,832,000 particles of 0.5 micron or larger are allowed to exist in a certain volume of air. The main goal of this cleanroom is to control airborne particles, thereby protecting the product from contamination and ensuring the stability of the manufacturing process. In a Class 8 Cleanroom, temperature and humidity are also strictly controlled to suit the needs of different industrial sectors.

According to ISO 14644, ISO 8 cleanrooms are typically required to have an air change rate of more than 20 times per hour to ensure that contaminants are removed quickly and a relatively constant level of cleanliness is maintained. In addition, ISO 8 cleanrooms must follow appropriate building codes and material selection during design and construction to minimize the generation and accumulation of particulate matter.

ISO 8 Cleanroom Industry Applications

ISO 8 cleanrooms are widely used in a variety of industries, especially those with high environmental requirements but relatively low cleanliness needs. The following are some of the main application areas:

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Food industry
In the process of food processing and packaging, ISO 8 modular cleanrooms can effectively prevent microbial contamination and ensure the safety and hygiene of food.
Electronic Product Manufacturing
While some high-end electronic products may require a higher level cleanroom, the production and assembly of certain low-end electronic components can be carried out in a ISO 8 environment.
Cosmetic Industry
During the production and packaging of cosmetics, a ISO 8 cleanroom can maintain the quality and stability of the product and avoid outside contamination.
Biotechnology
In the development and production of certain biological products, ISO 8 cleanrooms provide the necessary environmental controls to safeguard the purity and effectiveness of the products.

ISO 8 Cleanroom Construction Costs

The construction cost of a ISO 8 cleanroom varies depending on the region, design requirements and equipment configuration, but is usually relatively low compared to higher-level cleanrooms. According to market research, the construction cost of a ISO 8 cleanroom is roughly between RMB 2,000 and 4,000 per square meter, and the specific costs may include the following:

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Construction costs
including the design and construction of walls, floors, ceilings, doors and windows to ensure that the cleanliness requirements of a ISO 8 cleanroom are met.
Air treatment system
including high efficiency air filter (HEPA), air exchange system, temperature and humidity control equipment, etc. to ensure that the air quality meets the standard.
Monitoring and Control System
Necessary monitoring equipment and control system are used for real-time monitoring of particle concentration, temperature and humidity in the clean room.
Maintenance and operating costs
including the costs of regular testing, maintenance and operation to ensure the long-term stable operation of the cleanroom.

Related Standards and Codes

|Standard Number |Standard Name |Description |

| iso 14644-1 | Cleanliness ratings for cleanrooms and related controlled environments | Defines cleanliness ratings for cleanrooms and provides a standardized method of evaluation |

| GB 50073 | Fire Protection Code for Building Interior Design | Provides guidance on the selection of materials and fire protection requirements for cleanroom interiors | YY/T 0287 | Fire Protection Code for Building Interior Design | Provides standardized assessment methods for Cleanroom cleanliness ratings.

YY/T 0287 | Code for Cleanroom design of Medical Devices | Cleanroom design requirements for the medical device industry | GMP | Good Manufacturing Practice | GMP | Good Manufacturing Practice

| GMP | Good Manufacturing Practice | Manufacturing environment standards for the pharmaceutical industry covering clean room requirements |

ISO 8 modular cleanrooms play a vital role in controlling environmental contamination and protecting product quality. Despite their relatively low cleanliness requirements, they still play an essential role in some industries. By following international and domestic standards, as well as rational design and management, ISO 8 cleanrooms are able to effectively meet the needs of the industry and improve production efficiency and product safety.