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The level of a modular clean room is usually determined by multiple factors, the most important of which include industry demand, clean room equipment requirements, and product processes. Different application scenarios have different requirements for clean rooms, so it is necessary to determine the appropriate clean room level based on actual conditions.
Industries involved in clean rooms
1. Pharmaceutical industry
The pharmaceutical industry has extremely high requirements for clean rooms, especially when producing sterile drugs or vaccines. In order to prevent bacterial and particulate contamination, it is usually necessary to meet ISO 5 standards. ISO 5 requires that the number of 0.5 micron particles per cubic meter of air should not exceed 3,520 to ensure the purity and safety of the product.
2. Electronic industry
The cleanliness requirements in the production of electronic products are also very strict, especially for precision components such as Semiconductors and display screens. Clean rooms in the electronics industry generally require ISO 6 or ISO 7 levels. The requirement for ISO 6 Clean rooms is no more than 35,200 particles of 0.5 microns and above per cubic meter to prevent tiny dust from affecting product performance.
3. New Energy Industry
The new energy sector, especially the production of solar panels and lithium batteries, has certain requirements for clean environments. ISO 7 Clean rooms are more common in this industry, and the particle count is limited to no more than 352,000 particles larger than 0.5 microns per cubic meter, which helps improve battery efficiency and life.
4. Semiconductor Industry
The semiconductor manufacturing process has very high requirements for environmental cleanliness, and usually requires ISO 5 or higher clean rooms. This is because particulate contamination may directly affect the performance of integrated circuits. ISO 5 Clean rooms stipulate that there must be no more than 3,520 particles larger than 0.5 microns per cubic meter of air.
5. Food Industry
Although food production is not as strict as the pharmaceutical and electronics industries in terms of cleanliness requirements, ISO 8 Clean rooms are a more common standard to avoid contamination sources such as bacteria and mold. ISO 8 Clean rooms stipulate that the number of particles larger than 0.5 microns per cubic meter of air must not exceed 3.52 million.
Requirements for cleanroom-related equipment
1. Air filtration system
The air filtration system is the core equipment of the cleanroom, and HEPA and ULPA filters are common choices. HEPA filters can effectively filter more than 99.97% of particles of 0.3 microns, and ULPA filters can filter 99.999% of particles. The effect of the filtration system directly determines whether the cleanroom can reach the required level.
HEPA: Filtration efficiency ≥ 99.97% (0.3 micron particles)
ULPA: Filtration efficiency ≥ 99.999% (0.3 micron particles)
Equipment requirements: Ensure clean environment and reduce air pollution
2. Temperature and humidity control
The control of temperature and humidity is also very important in the modular cleanroom, especially for static control and product stability. In general, the temperature of the cleanroom should be maintained at 20℃ to 25℃, and the relative humidity should be controlled between 40% and 60%, which helps prevent static electricity in electronic components and deterioration of materials.
Temperature: 20°C - 25°C
Humidity: 40% - 60%
Function: Control static electricity, avoid material deterioration, and improve product stability
3. Monitoring and alarm system
Modern cleanrooms are usually equipped with real-time monitoring systems to monitor parameters such as air quality, temperature and humidity, and airflow. If there is a deviation, the system will automatically alarm. These monitoring devices help to detect problems in a timely manner, ensure that the cleanroom is always maintained within the set standard range, and avoid the emergence of pollution sources.
Product process requirements
1. The impact of process on clean room
Different product processes have different requirements for clean room levels. For example, dust control in semiconductor manufacturing is extremely strict, and ISO 5 or higher clean rooms are usually required to prevent dust from causing circuit short circuits or malfunctions. The higher the process complexity, the higher the requirement for environmental cleanliness.
2. Cleanliness requirements in the production process
In some multi-step production processes, different levels of clean rooms may be required at different stages. For example, during the initial assembly of electronic components, only ISO 7 Clean rooms may be required, while during the final testing and packaging process, a higher ISO 5 environment may be required.
3. Quality control and clean room level
The quality control link also determines the clean room level. For example, the pharmaceutical industry needs to ensure that the product is not contaminated by microorganisms and particles, so a strict dust-free environment is required. In the new energy industry, although the cleanliness requirements are lower, a moderate clean room level is still required to ensure the stability and durability of the product.
Determining the modular clean room level requires comprehensive consideration of multiple factors such as industry standards, equipment configuration, and product technology. Through scientific analysis and reasonable design, choosing the appropriate clean room level can ensure the environmental quality during the production process and guarantee the product's pass rate and safety.
Related standards and specifications
ISO 14644: Standards for clean rooms and related controlled environments
ISO level 5: Applicable to pharmaceutical, semiconductor, and electronic product production
ISO level 6: Applicable to the electronics industry
ISO level 7: Applicable to the new energy industry
ISO level 8: Applicable to the food industry
