Environmental requirements for Class 1000 cleanrooms

Environmental requirements for Class 1000 cleanrooms

Overview of Class 1000 Cleanroom standards

The environmental requirements for Class 1000 cleanrooms are based on the international standard ISO 14644-1. Under this standard, the number of particles larger than 0.5 microns per cubic meter of air in a Class 1000 Cleanroom must not exceed 1,000. This requirement ensures the air quality of the cleanroom and is suitable for production and experimental environments in industries such as pharmaceuticals, biotechnology, and electronics.

Temperature and humidity control

In a Class 1000 cleanroom, temperature and humidity control are critical. Typically, the temperature of the cleanroom should be maintained between 20°C and 24°C, and the relative humidity should be controlled between 30% and 60%. This range provides the best environment for most production processes while avoiding static electricity and changes in material properties.

Air flow and ventilation

Air flow and ventilation are important requirements for Class 1000 Cleanrooms. It is recommended to use a high-efficiency air filter (HEPA) for air purification to ensure uniform air flow in the cleanroom. The ventilation rate of the clean room should reach more than 20 times per hour to ensure the continuous renewal of indoor air and the timely removal of particles.

Surface cleanliness and material requirements

The surface cleanliness of the clean room directly affects the overall cleanliness of the environment. According to iso 14644-2, the surfaces in the clean room should meet specific cleaning standards, usually requiring the amount of surface dirt and particles to be minimized. In addition, the building materials of the clean room should be corrosion-resistant and easy to clean materials to reduce the accumulation of microorganisms and particles.

Personnel and article entry and exit management

In a Class 1000 Clean room, the entry and exit management of personnel and articles is an important means of controlling pollution. All personnel entering the clean room must wear compliant clean clothes, masks and gloves to ensure that individuals do not bring in pollution sources. At the same time, the entry and exit of articles should also pass through a special transfer window, and all articles must be cleaned and disinfected before entering.

1. iso 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness.

2. ISO 14644-2: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance.

3. ISO 14644-3: Cleanrooms and associated controlled environments - Part 3: Test methods for cleanrooms.

Uses of Class 1000 Cleanrooms

• Applications in the Pharmaceutical Industry

  Class 1000 cleanrooms play a vital role in the pharmaceutical industry, especially in the production of drugs and biopharmaceuticals. According to the international standard ISO 14644-1, the design requirements of Class 1000 cleanrooms ensure that there are no more than 1,000 particles larger than 0.5 microns per cubic meter of air. This environment can effectively prevent the contamination of drugs during the production and packaging process, ensuring the safety and effectiveness of the final product.

• Semiconductor Manufacturing

  In the field of semiconductor manufacturing, Class 1000 cleanrooms are the infrastructure to ensure product quality. The semiconductor manufacturing process involves micron-level material processing, so the environmental control of the cleanroom is particularly important. According to industry standards, the concentration of air particles in the cleanroom must be controlled within a specific range to avoid adverse effects on microelectronic components. Class 1000 cleanrooms can effectively reduce the defect rate caused by contamination during the production process and improve product yield.

• Aerospace Industry

  Class 1000 cleanrooms are also widely used in the aerospace industry. This industry requires extremely high product reliability and safety, so a clean environment must be ensured during the production and assembly of key components. In these clean rooms, the number of particles in the air is controlled within the ISO 14644-1 standard to ensure the performance and durability of components in extreme environments. The use of Class 1000 clean rooms helps reduce equipment failure rates and improve flight safety.

• Food Processing

  In the food processing industry, the application of Class 1000 Clean rooms is mainly reflected in the production process of high-risk foods. According to international standards, the cleanliness of the food production environment is directly related to the safety and quality of food. In a Class 1000 clean room, the control of microorganisms and particulate matter in the air can effectively prevent food contamination, thereby ensuring that the final product meets food safety standards and enhances consumer trust.

• Medical Device Production

  The production of medical devices also relies on Class 1000 clean rooms. According to the ISO 13485 standard, the design and manufacture of medical devices must comply with a strict quality management system, and the use of clean rooms is an important measure to ensure that products meet safety standards. Class 1000 clean rooms can effectively control the number of particles in the air, reduce the risk of contamination of equipment during production, packaging and storage, and ensure its safety and effectiveness in clinical applications.

• Research and Development

  In the field of scientific research and development, Class 1000 clean rooms provide the necessary clean environment for experiments. When researchers conduct biological experiments or material analysis, they need to control pollutants in the environment to obtain reliable experimental results. According to ISO 14644-1, the environmental requirements of clean rooms can effectively reduce variables in the experimental process and improve the repeatability and reliability of research results.

Design of Class 1000 Cleanroom

1. Air Flow Design：Air flow is crucial in the design of Class 1000 cleanrooms. Laminar flow systems are usually used in the design to ensure that clean air covers the entire working area at a uniform speed. According to industry standards, the air flow rate in the cleanroom is generally set between 0.45 m/s and 0.6 m/s to ensure effective particle dilution and control. Reasonable air flow design can effectively reduce the concentration of pollutants in the air.

2. Filtration System Design：High-efficiency filters are an indispensable part of Class 1000 cleanroom design. HEPA (High Efficiency Particulate Air Filter) or ULPA (Ultra High Efficiency Particulate Air Filter) is generally used to remove tiny particles in the air. The efficiency of HEPA filters can usually reach 99.97% for 0.3 micron particles, ensuring that the air quality in the cleanroom meets the ISO 14644-1 standard. The convenience of regular filter replacement should be considered in the design to maintain the efficient operation of the system.

3. Structural Material Selection：In the design of Class 1000 cleanrooms, it is crucial to choose the right structural material. Commonly used materials include stainless steel, aluminum alloy and special coating materials, which have good corrosion resistance and easy cleaning. At the same time, the materials of the floor, wall and ceiling should have low particle release characteristics to reduce pollution sources. The anti-static properties of the material should also be considered during design to prevent the impact of static electricity on the product.

Maintenance of Class 1000 Cleanrooms

Personnel Training and Management

The maintenance of cleanrooms is inseparable from the correct operation and management of personnel. It is very necessary to regularly train staff to ensure that they master the cleanroom specifications and maintenance processes. The training content should include the wearing specifications for entering the cleanroom, cleaning operation procedures, and emergency treatment measures. According to statistics, trained employees can reduce the number of particles in the cleanroom by more than 30%, thereby improving the overall environmental quality.

Equipment Maintenance and Calibration

All kinds of equipment in the cleanroom need regular maintenance and calibration to ensure their normal operation. The maintenance cycle of the equipment is usually 3 to 6 months, depending on the type of equipment and frequency of use. The calibration of the equipment should follow international standards, such as ISO 17025, to ensure the accuracy of the measurement results. Equipment failure not only affects the cleanroom environment, but may also cause production interruptions.