What is the difference between a 100,000-level clean room and a 10,000-level clean room, and what are the design and construction specifications of the clean room
The construction of a clean room is divided into many purification levels, so what is the difference between a 10,000-level clean room and a 100,000-level clean room? What is the difference between 10,000-class and 100,000-class dust-free workshops? What are the design and construction specifications for clean room purification engineering? Next, the editor of sz-pharma will introduce to you. The difference between the 10,000-level and 100,000-level clean room is mainly in several aspects: 1) Space: The level required by the clean room is the main factor determining the layout of the area. 2) Different levels of dust-free workshops require different temperature and humidity. Cleanliness is the key to choosing the number of air changes. The higher the cleanliness, the greater the number of air changes. The volume of high-efficiency tuyere at the end of the pipe also increases, and the factors controlling temperature and humidity, the higher the temperature and humidity control requirements, the more complete the supporting pharma machinery required, and the higher the cost. 3) The level requirements of the clean room are different, the illumination is different, and the number of lamps required is different. The difference between 10,000-level and 100,000-level is not limited to the above major aspects. From the above aspects, it can be seen that the difference in level makes the cost different. The higher the level, the higher the cost. The air cleanliness level in clean rooms and related controlled environments is divided according to the concentration of suspended particles in the air, that is, the maximum allowable number of particles per cubic meter of air is used to determine the air cleanliness level. 1. Several levels of clean pharmaceutical cleanroom: refers to the clean level, which can be understood as a clean room, but the clean room also needs to be ventilated. The air that is replaced needs to be purified by the clean room and then sent to the clean room. (100,000) level requires 15-19 air changes per hour, and the air purification time after complete ventilation does not exceed 40 minutes. 2. Purification parameters of 100,000-class, 10,000-class and 100-class clean workshops: ventilation times: 100,000 class ≥ 15 times; 10,000 class ≥ 20 times; 1000 ≥ 30 times; 100 ≥ 500 times. Adjacent room ≥5Pa Most of the workshops with the lowest requirements today use 100,000-level purification workshops; while 300,000-level purification sedimentation bacteria (cfu/, 100,000-level purification sedimentation bacteria (cfu/dish) is 10: 100,000-level ventilation parameters are ≥15 times/. Each cleanliness level has its own purpose, and the difference in purification is understood from the dust particles in the air; that is, the more air changes, the better. The design and planning of the purification project of the clean room need to be carried out in strict accordance with the industry standards: 1. Purification engineering design requirements 1. The purification engineering design must be strictly implemented in accordance with the relevant national policies and guidelines, so as to achieve scientific design, quality assurance, safety and application, and economy. energy and environmental protection requirements. 2. When using the original building for clean technology transformation, the design of the purification project must be based on the requirements of the production process, adjust measures to local conditions, treat them differently, and make full use of the existing technical facilities. 3. Purification engineering design should create necessary conditions for construction and installation, maintenance management, testing and safe operation. 4. The design of purification engineering should not only be carried out in accordance with this specification, but also comply with the relevant requirements of current international standards and specifications. Second, purification engineering grade 1, air cleanliness should be divided into five grades according to regulations. Class 10, Class 100, Class 1000, Class 10,000, Class 100,000 Note: For the calculation of dust particles greater than or equal to 5 microns in the purification project with air cleanliness of Class 100, multiple sampling should be performed. The test value can be considered reliable only when it appears multiple times. 2. The inspection of the air cleanliness level of the purification project should be based on the number of dust particles tested under dynamic conditions. The air cleanliness test of the purification project shall comply with the provisions of Appendix II. 3. The overall design of the purification project The selection of the location of the purification project and the general layout of the purification project should be determined according to the following requirements and after the comparison of the technical and economic plans: 1. It should be in an area with a low atmospheric dust concentration and a better natural environment; 2. It should be kept away from railways, wharfs, airports, traffic arteries, and factories, storage silos, storage yards and other areas with severe air pollution, vibration or noise interference that emit a large amount of dust and harmful gases. If it cannot be far away from serious air pollution sources, it should be located on the upwind side of the maximum frequency wind, or the leeward side of the minimum frequency wind throughout the year; 3. It should be arranged in a clean environment in the factory area, and the flow of people and goods does not pass through or rarely passes through. 4. For the location selection of the purification project with both micro-vibration control requirements, the vibration influence of the existing vibration sources around it should be actually measured, and it should be analyzed and compared with the allowable environmental vibration value of precision pharma machinery and precision instruments. 5. The maximum frequency wind direction in the purification project. When there is a chimney on the windward side, the horizontal distance between the purification project and the chimney should not be less than 12 times the height of the chimney. 6. The distance between the purification project and the main traffic road should not be less than 50 meters. 7. A ring-shaped fire lane (traffic road can be used) should be set up around the purification project. In case of difficulty, a fire lane can be set up along the two long sides of the factory building. 8. The road surface layer around the purification project should be made of materials with good integrity and less dust. 9. Greening should be carried out around the purification project. Lawns can be planted, trees that do not have harmful effects on atmospheric dust-laden agriculture can be planted, and greening communities can be formed. However, the fire fighting operation shall not be hindered.
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