What is a Class 10000 Cleanroom

Classification Standards for Cleanrooms

Cleanrooms are classified according to different levels of particle concentration in the air.The international standard ISO 14644-1 specifies the grades of cleanrooms in detail. 

The classification of modular clean rooms not only affects the design and construction standards, but is also directly related to the operating procedures and management specifications. Different levels of clean rooms will have different air filtration, temperature and humidity control, personnel management and environmental monitoring requirements. Understanding these standards is essential for the construction and daily operation of clean rooms.

• ISO5: No more than 3,520 particles > 0.5 microns per cubic meter.

• ISO6: No more than 35,200 particles > 0.5 microns per cubic meter.

• ISO7: No more than 352,000 particles > 0.5 microns per cubic meter.

FED-STD-209E：Class 10000 Cleanroom=ISO 7 Cleanroom

Dust particle count in 10000-class clean rooms

In a 10000-class clean room, the number of dust particles is a key indicator for evaluating cleanliness. According to the ISO 14644-1 standard, the allowable number of particles in a 10000-class clean room is no more than 352,000 particles > 0.5μm per cubic meter. To ensure that this standard is met, the design of the clean room must take into account multiple factors such as air flow, filtration system and personnel activities.

The monitoring of dust particle count usually uses a particle counter, which is an instrument that can measure the number of particles of different particle sizes in the air in real time. The measurement results of the particle counter can help managers determine the status of the clean room and take necessary cleaning and maintenance measures. In order to ensure the stability of the Class 10,000 clean room, it is recommended to conduct a comprehensive air quality test once a week to ensure that the particle concentration is always within the specified range.

In addition, the calculation formula for the number of dust particles is:

Particle concentration = Number of particles detected/Air volume

For example, in a 100 cubic meter clean room, if the number of particles detected is 30,000, the particle concentration is 300,000/cubic meter, which exceeds the standard of the Class 10,000 clean room. This monitoring method can effectively help companies detect problems in time and take effective control measures.

Schematic diagram of Class 10,000 clean room

The schematic diagram of the Class 10,000 clean room usually includes air circulation, filtration and conditioning systems. The core components include high-efficiency Air Filters (HEPA), airflow control devices, and temperature and humidity control systems. HEPA filters can remove 99.97% of particles with a diameter of 0.3μm, ensuring that the air entering the clean room meets the standards.

In the schematic diagram, the air is first purified by the external filtration system, and then enters the HEPA filter for deep filtration. The entire system usually adopts a laminar flow design to ensure that the air flows at a uniform speed and reduce the generation of dead corners and vortices. According to calculations, the flow rate is generally set to 0.45 m/s to maintain a good air exchange rate.

The temperature and humidity control system is also an important part of the Clean room design. Since excessive humidity in the air can cause microbial growth, the relative humidity of the 10000 class clean room is usually controlled between 30%-60%. At the same time, the temperature should be maintained between 20-22 degrees Celsius. The monitoring and control of these parameters requires modern environmental monitoring equipment to ensure that the environment in the clean room always meets industry standards.

10000 class clean room industry application

10000 class clean rooms are widely used in many industries, especially in pharmaceuticals, Semiconductors, Electronic manufacturing and biotechnology. In the pharmaceutical industry, clean rooms are used for the production and packaging of drugs to ensure that the products are produced in a pollution-free environment. According to statistics

According to statistics, in the pharmaceutical industry, about 70% of drug production needs to be carried out in a Class 10000 clean room. This is because in the production process of drugs, any tiny contaminants may cause the quality of drugs to decline and even affect the safety of patients. Therefore, pharmaceutical companies usually strictly control the concentration of particulate matter in clean rooms to ensure the safety and effectiveness of the final product.

In the field of semiconductor manufacturing, Class 10000 modular clean rooms are also crucial. In the production process of semiconductor chips, any tiny dust particles may cause defects and affect the performance and reliability of the chip. According to industry standards, it is usually necessary to achieve a particle concentration control of no more than 352,000 particles > 0.5μm per cubic meter on the chip production line to ensure the high quality of the product.

In addition, in the field of biotechnology, Class 10000 Clean rooms are used to research and produce vaccines, cell therapy and genetic engineering products. In these applications, the environmental control of the clean room directly affects the experimental results and the biosafety of the product. Many biotechnology companies regularly conduct environmental monitoring and verification of clean rooms to ensure that they meet relevant industry standards and regulatory requirements to avoid research failures or product failures due to environmental factors.

Cost of 10,000-class clean rooms

The cost of building a 10,000-class clean room varies depending on multiple factors, including design complexity, equipment selection, site selection, and construction materials. According to industry surveys, the total cost of building a 10,000-class clean room is usually between $5,000 and $20,000 per square meter, depending on the size and requirements of the project.

In terms of equipment, HEPA filters, airflow control systems, temperature and humidity control equipment, etc. are all high-cost components. The price of HEPA filters usually ranges from $500 to $2,000 each, depending on their filtration efficiency and size. In addition, the installation and maintenance of these devices will also incur corresponding expenses, and companies need to fully consider these long-term operating costs when budgeting.

In addition to equipment and construction costs, personnel management and training are also important expenses for clean room operations. The operation of clean rooms requires professionals, and companies need to conduct regular employee training to ensure the implementation of operating specifications and the effectiveness of environmental monitoring. This part of the training cost may account for 10% to 15% of the total budget. Therefore, when considering the cost of a Class 10,000 clean room, companies should comprehensively evaluate all related costs and formulate reasonable budgets and financial plans.

Class 10,000 clean rooms are important facilities in modern industry and scientific research, and their construction and operation need to follow strict standards and specifications. Through in-depth analysis of Clean Room Classification, dust particle count, schematics, industry applications, and cost, we can better understand the importance of this facility in various fields. With the development of science and technology and the increase in market demand, the design and technology of clean rooms are also constantly improving to meet more stringent cleanliness requirements. When investing in the construction and operation of clean rooms, companies need to fully consider various factors to ensure the effectiveness of their investment and the high quality of their products.