How is the cleanliness of a laboratory classified?
Release time:
2024-12-26
The classification of laboratory cleanliness levels is crucial for ensuring the precision of experiments and the quality of products. The internationally recognized standard is ISO 14644, while China has the GB 50073 - 2013 specification. The ISO 14644 standard ranges from ISO Class 1 to ISO Class 9, with decreasing cleanliness levels; the lower the class, the more suspended particles are allowed per unit volume. For instance, the ultra-clean ISO Class 1 permits only 10 suspended particles per cubic meter with a diameter of ≥0.1μm, suitable for ultra-precision electronic manufacturing, whereas ISO Class 9 has more lenient controls. Under China's standards, unidirectional flow cleanrooms include Class 100 and Class 1000, while non-unidirectional flow includes Class 10,000 and Class 100,000. Different levels correspond to various production and experimental scenarios, precisely matching the cleanliness requirements across different fields.
- ISO 14644 standard classification
- ISO Class 1: This is a level with extremely high cleanliness requirements. The maximum allowable number of suspended particles with a diameter greater than or equal to 0.1μm is only 10 per cubic meter of air, which is almost close to an absolute clean state. In critical processes of ultra-large-scale integrated circuit manufacturing, even tiny dust particles can cause chip short circuits and failures, so an ultra-clean environment like ISO Class 1 is required.
- ISO Class 2: The maximum allowable number of suspended particles with a diameter greater than or equal to 0.1μm is 100 per cubic meter of air. This level is suitable for experiments involving precision optical instrument assembly and high-purity material synthesis, where even slight impurities can interfere with optical performance or alter material properties.
- ISO Class 3: At this level, the maximum number of suspended particles with a diameter greater than or equal to 0.1μm is 1000 per cubic meter. Some sterile filling processes in high-end biopharmaceuticals and gene editing experiments can reduce microbial contamination and particle interference in this cleanliness environment, ensuring drug quality and experimental accuracy.
- ISO Class 4: The upper limit for suspended particles with a diameter greater than or equal to 0.1μm is 10,000 per cubic meter of air. This level is used for general sterile experiments and certain processes in electronic component manufacturing that have strict microbial and particle control requirements, preventing dust from causing short circuits in electronic components and microbial damage to experimental samples.
- ISO Class 5: The number of suspended particles with a diameter greater than or equal to 0.1μm does not exceed 100,000 per cubic meter. This level is common in cleanrooms for ordinary pharmaceutical production and general electronic assembly laboratories, maintaining a relatively clean and stable working space.
- ISO Class 6: The maximum allowable number of suspended particles with a diameter greater than or equal to 0.1μm is 1,000,000 per cubic meter of air. This level meets the basic cleanliness needs of most conventional laboratories, with many chemical analysis and material performance testing laboratories operating at this level.
- ISO Class 7: The number of suspended particles with a diameter greater than or equal to 0.1μm can reach up to 3,520,000 per cubic meter. This level is suitable for laboratories with slightly lower cleanliness requirements or as a buffer zone between clean and non-clean areas.
- ISO Class 8: The upper limit for suspended particles with a diameter greater than or equal to 0.1μm is 35,200,000 per cubic meter of air. This is considered a lower cleanliness level, where some industrial testing laboratories and teaching laboratories that have certain cleanliness requirements but are not highly sensitive may fall into this category.
- ISO Class 9: This is the lowest cleanliness requirement level, only making simple classifications with relatively loose control. Some open laboratories in schools and simple industrial testing sites fall into this category.
- China's GB 50073-2013 standard classification
- Unidirectional flow cleanroom levels: Further divided into Class 100 and Class 1000. Class 100 requires that the number of dust particles with a diameter greater than or equal to 0.5μm does not exceed 3,500 per cubic meter of air, equivalent to ISO Class 5, commonly used in sterile medical operations and ultra-precision electronic manufacturing; Class 1000 allows up to 35,000 dust particles per cubic meter with a diameter greater than or equal to 0.5μm, approximately equivalent to ISO Class 6, suitable for some high-demand electronic assembly and biological experiments.
- Non-unidirectional flow cleanroom levels: Divided into Class 10,000 and Class 100,000 etc. Class 10,000 stipulates that the number of dust particles with a diameter greater than or equal to 0.5μm does not exceed 350,000 per cubic meter, corresponding to ISO Class 7; Class 100,000 allows up to 3,500,000 dust particles per cubic meter with a diameter greater than or equal to 0.5μm, equivalent to ISO Class 8, frequently used in general pharmaceutical production and ordinary industrial cleanrooms.
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