Cleanroom Classification and Certification
2024.08.05
I. Introduction
In modern industrial production and scientific research, cleanrooms play a crucial role. Whether it's in the manufacturing of electronic chips, the development of biomedicine, or the production of precision instruments, there are extremely high requirements for the cleanliness of the environment. Understanding the classification and certification standards of cleanrooms is of great significance for ensuring product quality, improving production efficiency, and safeguarding the health of personnel. Today, let's delve deeply into this topic.
II. Classification of Cleanroom Levels
Cleanroom levels are typically classified based on the concentration of suspended particles in the air. Currently, the widely adopted international standard is ISO 14644-1.
ISO Class 1: This is the highest level of cleanroom, where the number of particles larger than or equal to 0.1 microns per cubic meter of air must not exceed 10.
ISO Class 2: The number of particles larger than or equal to 0.1 microns per cubic meter of air must not exceed 100.
ISO Class 3: The number of particles larger than or equal to 0.1 microns per cubic meter of air must not exceed 1000.
ISO Class 4: The number of particles larger than or equal to 0.1 microns per cubic meter of air must not exceed 10,000.
......and so on, until ISO Class 9.
For example, in the semiconductor manufacturing industry, chip production often requires an ISO Class 1 or ISO Class 2 cleanroom to avoid the impact of tiny particles on chip performance.
III. Certification Methods for Cleanroom Levels
The certification of cleanroom levels is typically carried out through the following methods:
- Particle Counting Method
Using professional particle counters to count particles of different sizes in the air to determine the cleanroom level.
- Sedimentation Bacteria Detection Method
By placing Petri dishes to collect sedimented microorganisms in the air, and after a period of incubation, calculating the number of colonies.
- Planktonic Bacteria Detection Method
Using planktonic bacteria samplers to collect planktonic microorganisms in the air for analysis and detection.
IV. Factors Affecting Cleanroom Levels
- Ventilation System
An efficient ventilation and filtration system can effectively remove contaminants in the air and ensure the air quality in the cleanroom.
- Personnel Activities
The entry and activities of personnel can bring in dust and microorganisms, which require strict control and management.
- Material Transfer
Materials entering the cleanroom must undergo cleaning and disinfection treatment to prevent contamination.
V. Conclusion
The classification and certification of cleanroom levels is a complex and rigorous process that is related to the development of many high-tech industries and product quality. With the continuous advancement of technology, the requirements for cleanrooms will become increasingly higher. Hopefully, through today's introduction, you have a deeper understanding of cleanrooms.
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