+86 18186671616
Jason@cleanroomequips.com
MENU
ISO 7 Cleanroom plays an important role in modern industry and scientific research, especially in those industries with extremely high environmental requirements. This article will analyze in detail the ISO cleanroom classification standards, the technical parameters of ISO 7 Cleanrooms, and their industry applications.
1. ISO CleanRoom Classification Standards
ISO CleanRoom Classification is based on the international standard ISO 14644-1, which divides cleanrooms into multiple levels, from ISO 1 to ISO 9, according to the maximum allowable concentration of particulate matter in the air. The smaller the grade number, the higher the cleanliness. Specifically, in an ISO 7 cleanroom, the number of particles with a diameter greater than 0.5 microns per cubic meter of air shall not exceed 352,000, and the number of particles with a diameter greater than 5.0 microns shall not exceed 200. This standard ensures the cleanliness of the environment and the ability to control pollution in specific industrial applications.
The following table lists the particle concentration standards for each ISO cleanroom class:
| ISO Class | Particle Concentration (per cubic meter) | Particle Size (μm) | Air Cleanliness Standard | Typical Applications |
|---|---|---|---|---|
| ISO 1 | ≤ 10 | 0.1 | Ultra-clean environment, virtually no contamination | Highly sensitive environments like semiconductor manufacturing, nanotechnology labs |
| ISO 2 | ≤ 100 | 0.1 | Extremely clean, ultra-high purity | High-precision instrument manufacturing, optical product production |
| ISO 3 | ≤ 1,000 | 0.1 | Very high cleanliness, nearly particle-free | Precision electronics, pharmaceutical manufacturing |
| ISO 4 | ≤ 10,000 | 0.1 | Extremely clean, no dust present | Semiconductor manufacturing, pharmaceutical processes, medical device production |
| ISO 5 | ≤ 100,000 | 0.5 | High cleanliness environment | Sterile pharmaceutical, medical device production, electronics assembly |
| ISO 6 | ≤ 1,000,000 | 0.5 | High cleanliness, suitable for general manufacturing | High-cleanliness electronics manufacturing, pharmaceuticals |
| ISO 7 | ≤ 352,000,000 | 0.5 | Medium-high cleanliness level | General electronics assembly, food processing, packaging |
| ISO 8 | ≤ 3,520,000,000 | 0.5 | Higher cleanliness, suitable for typical production environments | Food industry, lower-grade pharmaceutical production, general manufacturing |
By following these standards, companies can ensure that their production environment meets the stringent requirements of the relevant industry.
2. ISO 7 cleanroom technical parameters
ISO 7 cleanrooms need to meet a series of technical parameters that are critical to maintaining a clean environment.
First, the number of air changes
is an important indicator, and the number of air changes in ISO 7 cleanrooms is usually required to be more than 20 times/hour. This means that the air is replaced 20 times per hour, which effectively reduces pollutants in the air.
Second, temperature control** should be maintained in the range of 20℃ to 24℃ in ISO 7 cleanrooms, which helps ensure the comfort of operators and the stability of the process. **Humidity
is also critical, and relative humidity is usually required to be controlled between 30% and 60% to avoid static electricity and condensation of substances.
Finally, pressure difference
is an important factor in maintaining a stable environment inside the cleanroom. ISO 7 cleanrooms usually require positive pressure with the surrounding environment to ensure that external air does not enter the cleanroom through gaps, which can reduce the intrusion of pollution sources.
| Parameter | Specification for ISO 7 Cleanroom | Units |
|---|---|---|
| Maximum Particle Count | ≤ 352,000 particles per cubic meter (0.5 μm) | particles/m³ |
| Air Changes per Hour (ACH) | ≥ 30 to 60 | ACH |
| Airflow Velocity | 0.45 to 0.75 m/s (for laminar flow) | m/s |
| Temperature Range | 20°C to 24°C | °C |
| Relative Humidity | 30% to 60% | % RH |
| Maximum Surface Particle Count | ≤ 3,520 particles per 100 cm² (0.5 μm) | particles/100 cm² |
| Room Pressure | Positive pressure relative to surrounding areas | Pa (Pascal) |
| Lighting Levels | ≥ 300 lux | lux |
| Noise Level | ≤ 60 dB | dB |
| Classified Area | Entire room must meet ISO 7 standards for air cleanliness | - |
| Entry/Exit Protocol | Restricted access with gowning and airlock protocols | - |
Through the control of these technical parameters, ISO 7 cleanrooms can effectively reduce the concentration of particles and pollutants, thereby meeting the requirements of industry standards.
3. ISO 7 cleanroom industry application
ISO 7 cleanrooms are widely used in many industries, especially in pharmaceuticals, biotechnology, semiconductor manufacturing and aerospace. These industries have extremely strict requirements on the cleanliness of the environment, and the use of ISO 7 cleanrooms can effectively control microbial contamination and the generation of particulate matter.
In the pharmaceutical industry
ISO 7 cleanrooms are used for the production of sterile drugs to ensure that the products are not contaminated during the manufacturing process. According to international pharmaceutical standards, the production of all sterile preparations must be carried out in ISO 7 or higher cleanrooms to ensure the safety of patients' medication.
In the semiconductor industry
ISO 7 cleanrooms are an important part of the chip manufacturing process. In this process, the presence of tiny particles will directly affect the yield of the product, so a clean environment is required for production and testing.
In addition, the aerospace field
also requires ISO 7 modular clean rooms to manufacture and test high-precision equipment to ensure its reliability and safety in extreme environments. By implementing environmental control of ISO 7 Clean room standards in these industries, companies can ensure product quality and performance and reduce potential failure rates.
ISO 7 Clean rooms play a vital role in ensuring product quality and safety. By strictly following international standards and technical parameters, companies can effectively control environmental factors in clean rooms to ensure that applications in industries such as pharmaceuticals, semiconductors, and aerospace can achieve the desired results. With the continuous improvement of cleanliness requirements, the technology and management of ISO 7 clean rooms will also continue to iterate and upgrade to meet more stringent industry needs in the future.
Related standards and specifications
The following are domestic and international standards and specifications related to ISO 7 cleanrooms:
| Standard/Specification | Description |
| iso 14644-1 | Classification standards for cleanrooms and related controlled environments |
| iso 14644-2 | Monitoring and testing standards for cleanrooms |
| GMP (Good Manufacturing Practice) | Production quality management standards for the pharmaceutical industry |
| IEST-RP-CC003.3 | Design and operation guidance for cleanrooms and related environments |
| YY/T 0287-2008 | Basic specifications for cleanrooms in the pharmaceutical industry |
These standards provide systematic guidance for the design, operation and management of cleanrooms, ensuring that cleanrooms can meet the high requirements of the industry. By following these specifications, companies can more effectively maintain a clean environment and promote the sustainable development of science and technology and industry.
