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Class 10,000 Cleanroom - ISO7 Cleanroom Guidance

Related Information

1.What is a Class 10,000 cleanroom / ISO7 Cleanroom?
  A cleanroom is a room where the concentration of airborne particles is controlled. A Class 10,000 (ISO 7 cleanroom)refers to a room where the concentration of particles in the air meets the standards defined by ISO 14644-1.


2.Cleanliness Standards for Class 10,000 Cleanroom / ISO7 Cleanroom
ISO 14644-1 standards for airborne particles in clean areas:

ISO Classification Number (N)

The maximum concentration limit (pc/m³) for particles greater than or equal to the sizes considered in the table is calculated according to the formula in Section 3.2.

0.1μm

0.2 μm

0.3 μm

0.5 μm

1 μm

5 μm

ISO 1

10

2

 

 

 

 

ISO 2

100

24

10

4

 

 

ISO 3

1 000

237

102

35

8

 

ISO 4

10 000

2 370

1 020

352

83

 

ISO 5

100 000

23 700

10 200

3 520

832

29

ISO 6

1000 000

237 000

102 000

35 200

8 320

293

ISO 7

 

 

 

352 000

83 200

2 930

ISO 8

 

 

 

3 520 000

832 000

29 300

ISO 9

 

 

 

35 200 000

8 320 000

293 000

Note: Due to uncertainties in the measurement process, three valid figures are required to determine the concentration classification level.

 

  As shown in the table above, in a Class 10,000 cleanroom / ISO7 Cleanroom, the concentration of particles per cubic meter of air should not exceed:
352,000 for particles ≥ 0.5 μm
83,200 for particles ≥ 1.0 μm
2,930 for particles  ≥ 5.0 μm
There are no specific limits for particles smaller than 0.5 μm in a Class 10,000 (ISO 7) cleanroom, as these particles have minimal impact on the processes in the cleanroom.


3. Importance of Particle Control in Class 10,000 Cleanroom / ISO7 Cleanroom
  Maintaining the environment and controlling particles in a Class 10,000 cleanroom / ISO7 Cleanroom is crucial in various fields, including industrial production, scientific research, and healthcare. The key aspects are as follows:

Ensuring Product Quality:
  In industries such as electronics, pharmaceuticals, and biotechnology, cleanroom strictly control particulate matter to effectively prevent contamination and enhance product quality. For example: In the pharmaceutical industry, microorganisms and solid particles in the air can chemically interact with the ingredients of drugs, causing changes in their composition, affecting their stability and purity, and ultimately impacting their efficiency and safety.
In the semiconductor industry, airborne particles significantly affect product quality. The defect density of chips is closely related to the number of particles in the air. Additionally, tiny particles can cause lithography errors, leading to layout issues, short circuits, or open circuits in chips.

Ensuring Accuracy in Scientific Research:
  Environmental factors often have a significant impact on experimental results. Particle control in cleanroom provides a dust-free and sterile environment, ensuring the accuracy and reliability of experiments. This is particularly critical in fields that require high precision and purity, such as optics and semiconductors, where particle control is essential.

Protecting Health and Safety in Healthcare:
  In medical environments, even the smallest particles can become potential sources of infection, posing threats to patient health. Effective particle control in cleanrooms can reduce airborne particles, maintaining a clean and safe environment and safeguarding patient health.

  In summary, particle control is extremely important for the Class 10k cleanroom environment. To effectively control the particle concentration in the air of a Class 10k cleanroom, a three-stage filtration system (primary, medium, and HEPA filters) that meets regulatory requirements should be installed in the purification air supply system. Adequate purified recirculating airflow and proper airflow pattern must also be ensured. Additionally, personnel and materials entering the Class 10k cleanroom should be thoroughly cleaned and managed to prevent particles from impacting the product quality in the cleanroom.


4. Airflow Design for ISO7 Class 10,000 Cleanroom
  Airflow patterns in cleanrooms can be categorized as unidirectional flow (laminar flow), non-unidirectional flow (turbulent flow), mixed flow, and vector flow (diagonal flow).  ISO7 Class 10,000 Cleanroom typically utilize non-unidirectional (turbulent) airflow, with air supplied from the ceiling and returned at the lower sides. This design ensures sufficient recirculation airflow to meet cleanliness requirements while balancing cost-effectiveness and energy efficiency.

  For specific processes or areas with higher cleanliness requirements, localized laminar airflow can be adopted, resulting in a mixed airflow design (turbulent flow for the overall environment and laminar flow for specific workstations). This approach meets cleanliness standards for product quality and process requirements while avoiding the high costs of implementing laminar flow for the entire cleanroom.

  In addition, the arrangement of HEPA box or FFU in ISO7 Class 10,000 Cleanroom must be reasonable and uniform to ensure even airflow coverage in areas requiring enhanced cleanliness. The number and placement of HEPA box or FFU should be adjusted according to the cleanliness requirements of different areas. In specific zones, air passes through FFU HEPA filter, effectively removing dust, particles, bacteria, and other contaminants. The filtered clean air flows through the workspace at the required velocity, quickly removing contaminants generated within the workspace and preventing cross-contamination of airflow, ensuring that the work area meets the cleanliness standards required by the process.


5. Air Change Rate (air change per hour) for Class 10,000 Cleanroom
  The air change rate (air change per hour) is crucial for maintaining cleanliness and air quality in cleanroom. According to the ISO 14644-1 standard, the required air change rates for cleanroom are as follows:

 

 

Air Cleanliness Level

ISO Class

 

Airflow Type

Average Airflow Velocity (m/s)

 

Air Change Rate (m³/m²·h)

 

Application Examples

2

U

0.3~0.5

NA

Photolithography, Semiconductor Processing Areas

3

U

0.3~0.5

NA

Work Area, Semiconductor Processing Areas

4

5

U

U

0.3~0.5

0.2~0.5

NA

NA

Work Area, Multi-layer Mask Processing, Magnetic Disk Manufacturing
Semiconductor Service Areas, Utility Areas

6

M

0.1~0.3

 

Utility Areas, Multi-layer Processing Areas, Semiconductor Service Areas

 

N or M

NA

70~160

 

7

N or M

NA

30~70

Service Areas, Surface Treatment

8

N or M

NA

10~20

Service Areas

Note: NA = Not Applicable

  From the table, it can be seen that the air change rate (air change per hour) for a 10K cleanroom/ ISO7 Cleanroom should not be less than 30–70 air changes per hour. Within this range:

  When the impact of air quality or particles on product quality and safety is minimal, the lower end of the range can be selected to balance cleanliness requirements with cost and energy efficiency.
When particles, dust, bacteria, and other contaminants in the air significantly affect product quality, safety, personnel health, or work efficiency, or when higher stability requirements are needed for products, the upper end of the range or a slightly higher air change rate should be adopted. This prioritizes the requirements for production processes and safety.


6. Temperature, Humidity, and Pressure Control in Class 10,000 Cleanroom
  Temperature, humidity, and pressure control are critical factors in ensuring that the cleanroom environment meets specific requirements. The temperature and relative humidity in a cleanroom should primarily align with the production process needs. When there are no specific process requirements, the temperature in a Class 10,000 (ISO 7) cleanroom is typically maintained between 18–26°C, and the relative humidity is controlled between 45–65%.

  Proper temperature and humidity settings not only fulfill production process requirements and ensure personnel comfort but are also crucial for controlling static electricity and particulate generation. Higher relative humidity increases moisture in the air, which can effectively reduce or eliminate static electricity, preventing potential damage to products. Additionally, higher humidity promotes particle settlement, reducing particulate concentration in the air. However, excessive humidity may cause equipment or products to become damp or moldy. Conversely, low humidity (below 45%) increases static electricity, which is detrimental to products and leads to higher concentrations of airborne particles, complicating particle control.

  Pressure control in cleanrooms is essential for preventing contamination and cross-contamination. Typically, clean areas should maintain a positive pressure relative to surrounding ordinary environments to prevent external contaminants from entering. By adjusting the proportion of fresh air to exhaust air, the differential pressure can be managed. A pressure difference of no less than 10 Pa should be maintained between clean areas and non-clean areas. A proper pressure gradient (recommended at 10 Pa) should also be maintained between clean areas of different grades, with higher pressure in areas of higher cleanliness. This effectively prevents contamination from spreading to cleaner zones.


7. Monitoring and Maintenance of ISO7 Class 10,000 Cleanroom
  A cleanroom is a highly controlled environment designed for the production, manufacturing, and handling of products and technologies that demand strict control over particles and microorganisms. Therefore, monitoring particle levels is critically important. For critical positions and areas with higher cleanliness requirements, an online monitoring system can be installed to provide real-time monitoring. The monitoring frequency and sensor placement should be flexibly arranged according to the importance of the product process. In general clean zones, manual handheld instruments can be used for scheduled cleanliness checks.

Maintenance of a ISO7 10K cleanroom generally includes the following aspects:
1)Regular Inspection and Replacement of Filter: The cleaning and replacement cycle of filters varies depending on the usage environment. Typically, pre-filter should be cleaned once a month, medium-efficiency filter should be replaced every three months, and HEPA filter should be replaced annually. (HEPA filter can be replaced when their resistance reaches twice the initial resistance value)
2) Maintenance of HVAC Equipment: Perform regular performance checks and maintenance on HVAC components, including fans, heat exchangers (cooling or heating coils), humidifiers, and motors, to ensure proper operation. These checks should be conducted at least twice a year.
3) Calibration of Monitoring Equipment: Temperature and humidity sensors, pressure sensors, and other monitoring devices should be calibrated regularly, with calibration results recorded.
Additionally, Class 10,000 cleanrooms should undergo routine cleaning and maintenance, including walls, ceilings, and floors, with proper supervision and inspection.


8. Industry Applications and Special Requirements for Class 10,000 Cleanroom / ISO7 Cleanroom
  Class 10,000 cleanrooms /ISO7 Cleanroom are widely used in industries such as biopharmaceuticals, electronics, healthcare, and food processing.

  In the pharmaceutical industry, the manufacturing process requires a sterile environment. For terminally sterilized products,Class 10,000 cleanrooms /ISO7 Cleanroom is primarily used in processes like filling/sealing, preparation and filtration of high-contamination-risk products (e.g., those prone to microbial growth, prepared outside closed systems, or sterilized after extended delays), production of ophthalmic preparations, sterile ointments, sterile suspensions, and final cleaning of product-contact packaging materials and containers. For non-terminally sterilized products, Class 10,000 cleanroom is used in processes such as preparation and sterile filtration of solutions prior to filling.

  In the semiconductor and electronics industry, airborne particles significantly impact product quality, as the defect density of chips is closely linked to the concentration of particles in the air. Additionally, fine particles can lead to photolithography errors, affecting chip layouts and causing short circuits or open circuits. Controlling airborne particles is critical for ensuring chip yield and production quality. Class 10,000 cleanroom is mainly used in chip packaging, testing areas, and specific workshops for cutting, grinding, and polishing processes to ensure product reliability and performance.

class 10000 semiconductor cleanroom

  In the food processing and healthcare industries, stringent requirements for the environment, microorganisms, and chemical composition directly impact human health and safety. Class 10,000 cleanroom provide a dust-free, sterile environment with necessary sterilization measures integrated into the purification system to ensure production safety and quality.

  For cleanroom handling toxic or hazardous substances (e.g., in chemical industries, penicillin production, pathogenic agents, or radioactive pharmaceuticals), an independent purification HVAC system should be installed. A full supply and exhaust air system is recommended, with exhaust air treated through specialized systems tailored to the hazardous substances involved. The treated air must meet environmental standards before discharge.


9. Types, Characteristics, and Advantages of ISO7 Class 10,000 Modular Cleanroom
  Class 10,000 modular cleanrooms /ISO7 modular cleanroom modular cleanroom is primarily categorized into hardwall cleanroom and softwall cleanroom based on structural materials. Both types share the following common characteristics:

Characteristics

AIRKEY hardwall cleanroom

AIRKEY softwall cleanroom

Structural material differences

Rigid hardwall materials provide better sealing and higher structural strength

 

Flexible wall materials offer slightly lower sealing and structural strength

 

Room performance differences

Enables precise control of cleanliness, temperature, humidity, and room pressure parameters

Primarily used for cleanliness control, with less precise control of temperature, humidity, and room pressure due to weaker sealing and material properties

Construction cost differences

Generally more expensive than softwall cleanrooms

Cost-effective, with easier reuse and disassembly

Application environment differences

Ideal for production areas in industries such as electronics, pharmaceuticals, and healthcare with strict requirements for sealing, temperature, humidity, and pressure differentials

Suitable for environments with mild corrosiveness, laboratories, and production areas

 

10. What is the cost of a ISO7 Class 10,000 Modular Cleanroom?
  The cost of a ISO7 Class 10,000 modular cleanroom depends on several factors, including area, height, material selection, special requirements, and supporting facilities. Based on the client's specific needs, a corresponding ISO7 Class 10K modular cleanroom design and cost estimate can be provided. Most of the modular cleanroom components are pre-fabricated in the factory, with only rapid assembly taking place on-site. This significantly reduces the construction period and lowers on-site labor costs. As a result, the overall cost of a modular cleanroom is about 20% lower than a traditional cleanroom, and the installation time can be reduced by 40-50%.

ISO7 Class 10K Modular Cleanroom


11. How to ensure that a modular cleanroom meets ISO7 Class 10,000 cleanroom requirements?
  To ensure that a modular cleanroom meets ISO7 Class 10,000 cleanroom requirements, the design must strictly follow the requirements for Class 10,000 cleanliness, and the materials used in the modular cleanroom must meet the cleanliness requirements of not producing or accumulating dust.

  First, the air purification system should be equipped with the required HEPA air filter. Second, the modular cleanroom should be designed with sufficient air supply (the air exchange rate for a Class 10,000 cleanroom should not be less than 30-70 air changes per hour). Finally, the modular cleanroom must maintain the necessary pressure gradient and a reasonable airflow organization. Using appropriate materials that meet cleanliness standards can help the modular cleanroom achieve the Class 10,000 cleanliness level. After the modular cleanroom is designed and produced, it should undergo strict performance testing to ensure that the cleanliness meets the regulatory requirements.

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