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What is a Class 100,000 Cleanroom?

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-10-18  |  Visits:

A Class 100,000 cleanroom is a device used to control particulate matter pollution in the air in a specific environment. It is widely used in industries such as Electronics, pharmaceuticals, and food processing. According to the international standard ISO 14644, modular clean rooms are divided into multiple cleanliness levels, among which the cleanliness level of a Class 100,000 cleanroom is ISO 8. This standard provides a basis for the design, material selection, and operation of cleanrooms to ensure that they meet the environmental requirements of different industries.

ISO 14644 Cleanliness Level Standard

The ISO 14644 standard divides cleanrooms into nine levels, mainly based on the concentration of particulate matter in the air. The following is a detailed introduction to each cleanliness level:

1. ISO 5 (Class 100)

The maximum allowable particle concentration is 3,520 particles (≥0.5 microns) per cubic meter of air. This level is suitable for environments with extremely high cleanliness requirements, such as Semiconductor manufacturing and biopharmaceuticals.

2. ISO 6 (Class 1000)

Clean room grade standardsThe allowable particle concentration is 35,200 particles (≥0.5 microns). Suitable for the production of electronic components, it can effectively control the influence of static electricity and particulate matter.

3. ISO 7 (10,000-level)

The maximum allowable particle concentration is 352,000 particles (≥0.5 microns), which is suitable for most industrial production environments, such as the processing of medical devices.

4. ISO 8 (100,000-level)

The maximum allowable particle concentration is 3,520,000 particles (≥0.5 microns) per cubic meter of air. This level is suitable for industries with relatively low cleanliness requirements, such as food processing and some laboratory environments.

According to GB 50457-2014 "Clean Room Construction and Acceptance Specifications" and iso 14644-1 "Cleanliness Levels for Clean Rooms and Related Controlled Environments", the design and use of 100,000-level clean sheds should follow relevant standards to ensure the effectiveness and safety of their functions.

Purpose of 100,000-level clean sheds

100,000-level clean sheds are mainly used in industries that need to control air cleanliness, such as electronic manufacturing, food processing, pharmaceutical packaging and laboratory research. In electronic manufacturing, clean rooms can effectively prevent the impact of static electricity and particulate matter on products, thereby improving product quality and reliability. In the field of food processing, 100,000-level clean rooms are used to control the contamination of microorganisms and impurities to ensure the safety and hygiene standards of products. In pharmaceutical packaging, clean rooms can keep the packaging environment clean and avoid contaminating drugs, thereby complying with relevant regulations.

In addition, 100,000-level clean rooms are often used by small and medium-sized enterprises due to their relatively low construction and maintenance costs. They can be flexibly configured according to production needs, which helps to improve production efficiency and reduce operating costs. According to the "Design and Construction of Clean Rooms and Related Controlled Environments" standard, when selecting and using 100,000-level clean rooms, enterprises should combine actual needs to ensure that they can effectively meet the cleanliness requirements in the production process.

Working principle of 100,000-level clean rooms

Clean room working principle3.jpeg

The working principle of 100,000-level clean rooms mainly relies on FFU (fan filter unit) air supply and high-efficiency filter air purification. FFU draws in external air through a built-in fan and passes through a HEPA (high-efficiency particulate air) filter to remove particles ≥ 0.3 microns in the air. After filtering, Clean air is sent into the clean shed to maintain the cleanliness of the internal environment.

In the clean shed, a differential pressure gauge is installed to monitor the working status of the FFU in real time. When the differential pressure gauge shows an abnormality, it means that the FFU may be blocked or faulty, and maintenance and filter replacement are required in time. This design not only ensures the continuous and efficient operation of the clean shed, but also facilitates daily monitoring and management by operators, in line with the requirements of ISO 14644 standards.

Cost of a 100,000-level clean shed

The cost of a 100,000-level clean shed is affected by many factors, mainly including frame materials, enclosure materials, and FFU configuration. The following are several major aspects that affect the cost of the clean shed:

1. Frame material

- Industrial aluminum profiles: the highest price, strong durability, suitable for long-term use.

- Stainless steel square tube: medium price, good corrosion resistance, suitable for humid environments.

- Galvanized square tube: the lowest price, suitable for general environments, but poor durability.

Clean room material structure

2. Enclosure material

- Acrylic

High transparency, impact resistance, the highest price, suitable for environments where internal operations need to be observed.

- PC (polycarbonate)

Has good heat resistance and impact resistance, moderate price, suitable for most clean room applications.

- PS (polystyrene)

Low price, but poor durability and transparency, suitable for economic needs.

- PVC soft curtain

Lowest cost, suitable for occasions with high flexibility requirements, but does not have good isolation effect.

3. FFU (fan filter unit)

- Stainless steel FFU

High price, good corrosion resistance, suitable for demanding environments.

- Galvanized FFU

Moderate price, suitable for conventional clean room use.

- Motor type

DC motors are more efficient and quieter, but more expensive; AC motors are cheaper, but slightly inferior in energy efficiency and noise control.

According to market research, the cost of a 100,000-level clean room is usually between tens of thousands and hundreds of thousands of RMB, and the specific price varies depending on the material selection and configuration. When making budgets and choices, enterprises need to comprehensively consider the use environment, cleanliness requirements and long-term maintenance costs to ensure the rationality and effectiveness of the investment.

As an important facility in modern industry and scientific research, the design, construction and use of the 100,000-level clean shed should strictly follow relevant standards such as ISO 14644. By reasonably selecting frame materials, enclosure materials and FFU configurations, enterprises can control costs and improve production efficiency while meeting cleanliness requirements. With the development of science and technology, the application areas of clean sheds will continue to expand. I believe there will be more innovations and improvements in the future to meet the ever-changing market needs.

Clean room real scene

List of relevant specifications

1. ISO 14644-1

- Cleanroom and related controlled environment cleanliness level

2. GB 50457-2014

- Cleanroom construction and acceptance specifications

3. ISO 14644-3

- Cleanroom and related controlled environment monitoring methods

4. ISO 14644-4

- Cleanroom and related controlled environment design

5. iso 14644-5

- Cleanroom and related controlled environment operation and maintenance

By following these standards and specifications, enterprises can ensure the efficient operation of Class 100,000 modular clean rooms, improve product quality, and meet industry requirements.

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