+86 18186671616
Jason@cleanroomequips.com
About the number of suspended particles in the air of ISO 5 Cleanrooms
Overview of ISO 5 cleanroom standards
ISO 5 Cleanrooms are defined according to the International Organization for Standardization (ISO) standard 14644-1 and are suitable for environments that require a high degree of control of suspended particles in the air. In an ISO 5 cleanroom, the number of airborne particles larger than 0.5 microns (µm) is not allowed to exceed 3,520 per cubic meter of air. This standard is critical for industries such as pharmaceuticals and Semiconductors, where cleanliness requirements are extremely high and any tiny contamination may affect product quality.
Aerosol particle limits
According to the ISO 14644-1 standard, ISO 5 cleanrooms have very clear limits on airborne particles, especially for particles larger than 5.0 microns, which require no more than 29 particles per cubic meter of air. These strict limits ensure that there are almost no contaminants in the environment during critical production processes, ensuring the safety and effectiveness of sensitive operations such as sterile drug preparation and Electronic component manufacturing.
Monitoring and Compliance Requirements
To ensure compliance with ISO 5 standards, it is essential to regularly monitor suspended particles in the air. Companies need to use calibrated laser particle counters to assess air quality and ensure that particle counts are always within the specified range. In addition, cleanroom operators should implement regular cleaning and maintenance programs to reduce the risk of contamination, thereby ensuring the continued control and compliance of the environment.
Related Standards and Specifications
To successfully implement the ISO 5 cleanroom standard, organizations should refer to the following specifications:
iso 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness.
iso 14644-2: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance.
ISO 14644-3: Cleanrooms and associated controlled environments - Part 3: Test methods for cleanrooms.
Air Changes in ISO 5 Cleanrooms
Overview of ISO 5 Cleanroom Standards
ISO 5 cleanrooms are designed to provide extremely low levels of air contamination. According to ISO 14644-1, ISO 5 cleanrooms require that the number of 0.5 micron particles in the air must not exceed 3,520 per cubic meter. In order to maintain this cleanliness, the number of air changes per hour (ACH) is a key indicator that directly affects the air quality and particle control of the cleanroom.
Calculation of Air Changes
In ISO 5 cleanrooms, the recommended air change rate is usually at least 100 air changes per hour. This means that the air in the cleanroom will be completely renewed 100 times in an hour, effectively reducing the number of suspended particles in the air. This high frequency of air changes ensures that any potential contaminants are quickly expelled, thereby maintaining a clean working environment.
Environmental Control and Temperature and Humidity
In addition to the number of air changes, ISO 5 cleanrooms also need to control temperature and humidity to ensure cleanliness. Typically, the relative humidity in a cleanroom should be maintained between 30% and 60%, while the temperature should be maintained between 20 and 22 degrees Celsius. These environmental parameters not only help control particulate matter, but are also critical to the comfort of workers and the normal operation of equipment.
Environmental requirements for ISO 5 cleanrooms
1. Temperature control requirements：The temperature of ISO 5 cleanrooms usually needs to be maintained between 20-22 degrees Celsius. This temperature range not only helps maintain the normal operation of equipment, but also provides a comfortable working environment for staff. Too high or too low temperature may affect the flow of air, thereby affecting the air quality and particulate control in the cleanroom.
2. Humidity control requirements：Relative humidity is another important parameter in the environmental requirements of ISO 5 cleanrooms. Generally, the relative humidity of the cleanroom should be maintained between 30%-60%. The appropriate humidity level can effectively prevent the accumulation of static electricity and protect electronic components and products from damage. At the same time, too high humidity may also cause the growth of mold and bacteria, affecting the overall hygiene of the cleanroom.
3. Air flow rate and air changes per hour: The air flow rate and air changes per hour (ACH) of ISO 5 cleanrooms are also important environmental requirements. Generally speaking, the recommended air changes are more than 100 times per hour. This means that the air in the clean room will be completely replaced 100 times in an hour, ensuring that particulate matter in the air can be discharged in time and maintaining the air quality of the clean room.
Monitoring of ISO 5 cleanrooms
1. Air quality monitoring
In ISO 5 cleanrooms, air quality monitoring is the top priority. Online monitoring with a high-efficiency particle counter should be used regularly to obtain the number of particles of different sizes in the air. The monitoring frequency is recommended to be once an hour to ensure that the air status in the cleanroom can be reflected in real time, and the problem of exceeding the standard can be discovered and handled in time.
2. Temperature and humidity monitoring
Temperature and humidity are two important factors affecting the cleanroom environment. The temperature of ISO 5 cleanrooms should be maintained at 20-22 degrees Celsius, and the relative humidity should be controlled between 30%-60%. It is recommended to use a digital thermometer and hygrometer for real-time monitoring and set up an automatic alarm system so that measures can be taken immediately when the temperature and humidity exceed the set range to prevent the production process from being affected.
3. Equipment status monitoring
In order to ensure the normal operation of equipment in ISO 5 cleanrooms, equipment status monitoring is also an important part that cannot be ignored. Equipment such as air conditioning systems, filters and airflow detectors need to be inspected and maintained regularly. It is recommended to conduct a comprehensive equipment inspection every 6 months and record relevant data to ensure that the equipment functions in the best condition and meets the requirements of the clean room.
4. Personnel entry and exit monitoring
The personnel entry and exit monitoring in the clean room is an important part of controlling pollution. A monitoring system for personnel entry and exit should be set up, including inspection of wearing compliant clean clothes and entry and exit records. The entry and exit time and frequency of each employee should be recorded every day to track and manage potential sources of contamination and ensure the safety of the clean room environment.
Cleaning of ISO 5 cleanrooms
Selection of cleaning tools
Choosing the right cleaning tools and materials is key to maintaining an ISO 5 cleanroom. It is recommended to use dust-free cloths, static-eliminating mops, and dedicated cleanroom cleaners to reduce the risk of particulate release and cross-contamination. Cleaning tools should be disinfected and replaced regularly to ensure their effectiveness and avoid secondary contamination.
Maintenance of air filtration systems
In ISO 5 cleanrooms, the cleaning and maintenance of air filtration systems cannot be ignored. High-efficiency Air Filters (HEPA) are usually replaced every 6 to 12 months, depending on usage and environmental monitoring results. By regularly checking and replacing filters, the air quality of the cleanroom can be maintained to ensure that ISO 5 standards are met.
Personnel cleaning and training
Personnel cleaning and training are an important part of maintaining an ISO 5 cleanroom. All employees entering the cleanroom must receive relevant training and master the behavioral norms and cleaning procedures in the cleanroom. Employees must do a good job of personal cleanliness before entering, including wearing compliant clean clothes, masks and gloves to reduce personal pollution sources.
