The difference between clean room class 10000 and class 100000

The difference between Class 10000 and Class 100000 clean rooms

1. Air particle concentration standards for clean rooms

The grade standard of a clean room is first determined by the particle number concentration in the air. According to the ISO 14644-1 standard, the grade of a clean room is based on the maximum allowable number of particles of a certain size per cubic meter of air. For example, the particle concentration limit for a Class 10000 Clean room is much stricter than that for a Class 100000 clean room. These concentration limits are critical to ensuring the cleanliness of the clean room and the stability of the production environment.

• Class 10000 Clean room: The maximum concentration of 0.5 micron particles allowed in the air is 3,520,000 per cubic meter.

• Class 100000 clean room: The maximum concentration of 0.5 micron particles allowed in the air is 35,200,000 per cubic meter.

2. Different requirements in application fields

Cleanrooms of different levels are suitable for different industries and technical needs. Class 10000 Cleanrooms are usually used in places that are very sensitive to particulate contamination, such as semiconductor manufacturing, microelectronic component production, and precision optical instrument assembly. Class 100000 cleanrooms are widely used in environments with relatively loose requirements, such as pharmaceutical industry, food processing, and laboratory environment.

①Applications of Class 10000 Cleanrooms:

• Semiconductor manufacturing

• Display, LED production

• Precision electronic assembly

②Applications of Class 100000 cleanrooms:

• Pharmaceutical industry

• Biopharmaceutical research and development

• Food packaging

3. Differences in air exchange rate and flow rate

Air exchange rate (ACH, Air Changes per Hour) and air flow rate are important indicators for measuring the ventilation effect of clean rooms. Class 10000 cleanrooms usually require higher air exchange rates and stricter air flow rate control to ensure the cleanliness of the environment due to the higher particle control requirements. In contrast, Class 100000 cleanrooms can be slightly more relaxed in terms of air flow rate and exchange rate requirements.

• Class 10000 cleanroom:

• The air exchange rate is usually 300-600 times/hour.

• The air flow rate requirement is 0.45-0.60 m/s.

• Class 100000 cleanroom:

• The air exchange rate is usually 100-300 times/hour.

• The air flow rate requirement is 0.30-0.45 m/s.

4. Cleanliness control and maintenance requirements

In the daily management of cleanrooms, maintenance and monitoring are important factors to ensure that cleanliness standards are maintained for a long time. Class 10000 cleanrooms require more frequent monitoring and maintenance due to their stricter cleanliness requirements, including stricter air quality testing and equipment calibration. Class 100000 cleanrooms have looser maintenance standards, but they still require regular inspection and maintenance.

①Class 10000 cleanroom maintenance:

• Regular inspection of air filtration systems (HEPA/ULPA filters)

• More frequent air quality monitoring

• Strict cleaning and disinfection procedures

②Class 100000 cleanroom maintenance:

• Regular inspection of air filtration systems (HEPA filters)

• Regular cleaning and environmental monitoring

• iso 14644-1: Air cleanliness standards for cleanrooms and related controlled environments.

• iso 14644-2: Monitoring and testing requirements for cleanrooms.

• ISO 14644-4: Design and construction standards for cleanrooms.

• iso 14644-5: Cleanroom operating procedures and maintenance requirements.

What are the air changes for Class 100000 clean room?

Air Change Rate

Class 100,000 clean rooms typically require an air change rate of 15 to 30 air changes per hour. This ensures that contaminants are effectively removed from the environment, maintaining the required cleanliness level.

Importance of Air Changes

Frequent air changes are crucial in maintaining the cleanliness of Class 100,000 rooms. With each air change, particulate matter is reduced, which helps protect sensitive processes and products within the clean room.

Factors Influencing Changes

The exact number of air changes needed can vary based on factors such as room size, occupancy, and the specific processes being conducted. Careful design and monitoring are essential to optimize air change rates.

What is the pressure difference between clean rooms?

• Pressure Difference Basics

Clean rooms are maintained at a pressure differential relative to adjacent areas to prevent contamination. Typically, a pressure difference of 0.02 to 0.05 inches of water column is maintained.

• Positive vs. Negative Pressure

Positive pressure is often used in clean rooms to keep contaminants out, while negative pressure is common in areas like laboratories to contain potential contaminants. This pressure management is vital for safety and cleanliness.

• Monitoring Pressure Levels

Regular monitoring of pressure differentials is necessary to ensure compliance with clean room standards. Proper gauges and controls help maintain the specified pressure levels, ensuring effective contamination control.

What is the highest class clean room?

1. Definition of Highest Class

The highest class of clean room is classified as ISO Class 1. This environment has a maximum allowable particle count of 10 particles per cubic meter for particles ≥0.1 micrometers, making it extremely clean.

2. Applications of Class 1

ISO1 clean rooms are typically used in high-tech industries such as semiconductor manufacturing, aerospace, and biotechnology. Such stringent requirements are essential for processes where even minute contamination can lead to product failure.

3. Comparison with Other Classes

ISO1 has significantly stricter standards than lower classes. For example, ISO5 allows up to 3,520 particles per cubic meter, highlighting the advanced cleanliness of Class 1 environments.

Is Clean Room Same as Buffer Room?

• Functional Difference

The main function of a clean room is to control particles and microorganisms in the air to meet specific cleanliness requirements. The buffer room is used to provide a transition space between the sterile area and the outside world to prevent contamination.

• Application Scenarios

Clean rooms are widely used in industries such as pharmaceuticals, semiconductors, and aviation. Buffer rooms usually appear in the production process of sterile preparations as a buffer between sterile rooms and other areas.

What is the Difference Between a Clean Room and a Sterile Room?

1. Environmental Control：

Clean rooms control particulate matter through high-efficiency filters and air replacement systems, while sterile rooms rely on disinfection and sterilization technology to ensure the absence of microorganisms.

2. Application Fields：

Clean rooms are commonly used in semiconductor manufacturing, pharmaceuticals, and electronics industries, while sterile rooms are mainly used in pharmaceutical preparations, operating rooms, and medical experiments to ensure sterile conditions.

3. Standards and Certifications：

The standards for clean rooms are based on the ISO 14644 series, while sterile rooms follow more stringent sterility standards such as the United States Pharmacopeia (USP). These standards ensure the safety and effectiveness of different environments.