ISO 14644-1 is an important standard published by the International Organization for Standardization (ISO) that defines the air cleanliness levels for cleanrooms and related controlled environments. The standard provides clear guidance for cleanroom design, operation and validation worldwide, ensuring that various industries can achieve the required air quality standards, especially in areas with extremely high cleanliness requirements such as pharmaceuticals, electronics and aerospace.
1. Cleanliness Classification
According to ISO 14644-1, the air cleanliness level of a cleanroom is classified by measuring the number and size of particles per cubic meter of air. The standard divides cleanrooms into multiple levels, usually from ISO Class 1 to ISO Class 9, where Class 1 represents the most stringent cleanliness requirements. Specifically, Class 1 allows only 10 particles with a diameter of 0.1 microns per cubic meter, while Class 9 allows 350,000,000 particles of the same diameter per cubic meter. Such a classification system allows clean rooms in different application areas to select appropriate standards according to actual needs.
Table 1: Overview of ISO 14644-1 Classification Standards
| ISO Class | Number of 0.1 micron particles (per cubic meter) | Number of 0.2 micron particles (per cubic meter) | Number of 0.3 micron particles (per cubic meter) |
| Class 1 | 10 | 2 | 0 |
| Class 2 | 100 | 24 | 10 |
| Class 3 | 1,000 | 237 | 102 |
| Class 4 | 10,000 | 2,370 | 1,020 |
| Class 5 | 100,000 | 23,700 | 10,200 |
| Class 6 | 1,000,000 | 237,000 | 102,000 |
| Class 7 | 10,000,000 | 2,370,000 | 1,020,000 |
| Class 8 | 100,000,000 | 23,700,000 | 10,200,000 |
| Class 9 | 350,000,000 | 75,000,000,000 | 40,000,000,000 |
2. Air quality standards
ISO 14644-1 not only defines the classification of clean rooms, but also specifies the air quality standards in detail. These standards focus on controlling particulate contamination to protect the quality of the manufacturing process and the final product. For example, in the pharmaceutical industry, tiny particles in the air may affect the safety and effectiveness of drugs, so strict control measures must be adopted. ISO 14644-1 requires that cleanrooms be regularly monitored for air quality and that the required air cleanliness be maintained through efficient filtration systems and ventilation equipment.
According to ISO 14644-1, air flow and ventilation rate in cleanrooms are also critical. For some rooms with high cleanliness levels, the ventilation rate can reach more than 30 times per hour to ensure continuous freshness of the air and timely removal of particles. This efficient air handling capacity is the basis for ensuring product quality and worker safety.
3. Monitoring requirements
ISO 14644-1 clearly specifies the requirements for air quality monitoring in cleanrooms. Depending on the cleanliness level, the monitoring frequency and particle size range also vary. For example, for ISO Class 5 cleanrooms, monitoring should be carried out at least monthly, and attention should be paid to particles with a particle size of 0.1 microns and above. Monitoring methods include the use of equipment such as laser particle counters to obtain real-time concentration data of particles in the air.
In addition, the standard also requires regular verification and confirmation during the construction, use and maintenance of cleanrooms to ensure that the air cleanliness meets the specified standards. This continuous monitoring and verification mechanism can not only detect potential air quality problems in a timely manner, but also provide data support for clean room management and help formulate improvement measures.
List of related specifications
ISO 14644-1:2015 - Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness
ISO 14644-2:2015 - Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3:200- ISO 14644-3:2005 - Cleanrooms and associated controlled environments Part 3: Test methods
ISO 14644-4:2001 - Cleanrooms and associated controlled environments Part 4: Design, construction and start-up
ISO 14644-5:2004 - Cleanrooms and associated controlled environments Part 5: Operations
ISO 14644-6:2015 - Cleanrooms and associated controlled environments Part 6: Vocabulary
In the context of globalization, ISO 14644-1 also provides a unified standard for international trade, which is conducive to the exchange and cooperation of cleanroom technology between different countries and regions. As a cleanroom equipment developer, in-depth understanding and application of this standard can not only improve the market adaptability of products, but also meet customers' high standards for cleanliness, and contribute to the sustainable development of the industry.
With the advancement of technology and changes in industry needs, ISO 14644-1 will continue to be updated and improved to adapt to new challenges. Therefore, developers and related practitioners need to keep an eye on the dynamics of the standard to ensure that the design and operation of cleanrooms always meet the latest international specifications. Through continuous learning and practice, we can better cope with various challenges in the cleanroom field in the future and ensure product quality and user safety.
