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what is iso class 7 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

  • 2024-09-27  |  Visits:

I. What is a clean shed

Clean room (simple clean room) is a simple clean room established for quick and convenient, clean room with a variety of cleanliness levels and space with, can be designed and produced according to the needs of the use, so it is easy to use the flexibility, easy to install and short construction period and removability as its main features. The clean room can be used for the clean room in the general level of the local area in need of high cleanliness in order to reduce the cost of local additions.

 

2, cleanliness level standard level grading situation

 ISO cleanliness level standard is an international standard for measuring cleanliness, which is widely used in clean rooms, laboratories, Electronics industry, Pharmaceutical industry and food industry and other fields. According to ISO 14644-1 standard, the cleanliness level is divided into 1 to 9 levels, each level corresponds to a specific number of suspended particles in the air. The details are as follows:

- ISO1: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 10.

- ISO2: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 100.

- ISO3: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 1000.

- ISO4: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 10,000.

- ISO5: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 100000.

- ISO6: The number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 1,000,000.

- ISO7: The number of particles greater than or equal to 0.1μm per cubic meter of air shall not exceed 10000000.

- ISO8: The number of particles greater than or equal to 0.1μm per cubic meter of air shall not exceed 100000000.

- ISO9: cleanliness is relatively low, the number of particles greater than or equal to 0.1μm per cubic meter of air does not exceed 1000000000.


3. ISO7 Cleanroom standards

ISO cleanliness class standard

In terms of the number of air changes.

100000 (100,000) level requires 18-25 air changes per hour, and the air purification time after complete air changes does not exceed 40 minutes.

iso 7 requires 25-30 times per hour, complete air purification time after air exchange does not exceed 30 minutes 1000 (1,000) level requires 40-60 times per hour, complete air purification time after air exchange does not exceed 20 minutes.

Various levels including ISO 7 Cleanroom cleanliness standards refer to the following.

ISO according to the concentration of suspended particles this * indicator to classify the modular clean room (area) and related controlled environments in the air cleanliness level, and only consider the particle size limit (low limit) in the range of 0.1um ~ 5.0um in the cumulative distribution of the particle group +.

Depending on the particle size, they can be classified as conventional particles+ (0.1um~5.0um), ultrafine particles+ (<0.1um) and macro particles (>5.0um).

100,000 clean room purification + standard

1. dust particles + large allowable number (per cubic meter).

2. The number of particles larger or equal to 0.5 micron shall not exceed 3,500,000, and the number of particles larger or equal to 5 micron shall not exceed 20,000.

3. The number of microorganisms shall not exceed

4. The number of planktonic bacteria shall not exceed 500 per cubic meter.

5. The number of sinking bacteria shall not exceed 10 per petri dish.

Differential pressure: the same cleanliness level of the purification workshop to maintain the same differential pressure, for different cleanliness levels of neighboring purification workshop pressure difference between ≥ 5Pa, purification workshop and non-purification workshop to z10Pa.

 

4. ISO7 Cleanroom Application Areas

Laboratory: Clean shed can be used in the laboratory for part of the experimental area of the clean environment requirements, in order to prevent impurity contamination in the experimental process.

Medical industry: clean shed can be used in the operating room, clean laboratory, clean pharmacy and other medical environments to reduce the risk of intraoperative infection.

Electronic industry: clean shed is widely used in the manufacturing process of electronic components to prevent dust and other impurities contamination of electronic products.

Pharmaceutical industry: clean shed can be used in the pharmaceutical process of drug packaging, preparation and blending and other links to ensure product cleanliness and quality requirements.


 

5. Principle of ISO7 cleanroom

The working principle of ISO7 cleanroom mainly includes the following aspects:

1. Air filtration technology: The air in the clean room is filtered by multi-layer high-efficiency filters (e.g., HEPA and ULPA), which effectively reduces the number of particles and microorganisms in the air.

2. Positive Pressure Maintenance: Positive pressure is maintained inside the cleanroom so that the air flows from the inside of the cleanroom to the outside, preventing the entry of external contaminants. At the same time, this positive pressure also ensures that the air fully passes through the filter.

3. Temperature, humidity and static electricity control: Internal environmental parameters such as temperature, humidity and static electricity are precisely controlled to ensure stability within a certain range, thus avoiding the impact on products and experiments.

 

6. ISO7 Cleanroom Management Requirements

iso 7 clean room


1. Personnel Control: Personnel entering the modular cleanroom are required to wear specialized clean suits and follow specific procedures for entry and exit to reduce the introduction of particulate matter and microorganisms. In addition, personnel are required to receive special training on cleanroom practices.

2. Material transportation: Materials should be kept dry and airtight during transportation to avoid contamination. The transportation process must strictly control the temperature, humidity and other environmental factors to ensure the quality of materials.

 

Through the above introduction to the ISO7 clean room, we can see its role in the modern industrial

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