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Building a dust-free workshop for medica2024-02-01
Design of Food Cleanroom2024-02-01
Building a dust-free workshop for medical devices |
Publisher:Suzhou Lingxi Purification Engineering Co., Ltd. ©¦ Click count£º598 ©¦ Publication time£º2024-02-01 15:18:46 ©¦ close |
| Sterile medical devices are any medical devices marked as "sterile". The construction of a dust-free workshop is a basic condition to ensure the quality of sterile medical devices. It is necessary to control the environment of the sterile medical device production process and standardize its production to prevent environmental pollution of sterile medical devices. In order to meet customer requirements, the construction of dust-free medical device workshops, drug production workshops, medical biology laboratories, pharmaceutical purification workshops, operating rooms, etc, We will strictly follow the following seven construction requirements: 1¡¢ Requirements for site selection of dust-free workshop construction 1. The natural environment and hygiene conditions around the location are good, with at least no sources of air or water pollution, and it is also advisable to stay away from transportation arteries, freight yards, etc 2. The ground and roads in the factory area should be level and dust-free. It is advisable to reduce the exposed soil area or take measures to control dust through greening and other measures. Garbage, idle items, etc. should not be stored outdoors. In short, the environment of the factory should not cause pollution to the production of sterile medical devices. 3. It is not allowed to have adverse effects on the production area of sterile medical devices, especially the clean area. 2¡¢ Requirements for the layout of dust-free workshop construction According to Appendix B of YY0033-2000 "Sterile Medical Device Production Management Specification", the cleanliness level of the sterile medical device production environment should be set according to the guidelines. In the design of a dust-free workshop, attention should be paid to the following aspects: 1. The per capita area of the clean room should not be less than 4 square meters (except for corridors, equipment, and other items), ensuring a safe operating area. 2. Arrange according to the production process flow. Reasonable flow of people and logistics. A personnel purification room (outer clothing room, washroom, clean work clothes room, and buffer room) and a material purification room (unpacking room, buffer room, and double-layer transfer window) must be equipped. In addition to the outdoor areas required by the product process, a sanitary ware room, laundry room, temporary storage room, and workstation equipment cleaning room should also be equipped. Each room should be independent of each other, and the area of the clean workshop should be suitable for the production scale while ensuring basic requirements. 3. There is no pollution within the same clean room (area) or between adjacent clean rooms (areas). 4. According to the level of air cleanliness, it can be written as follows the direction of human flow, from low to high; The workshop is from the inside out, from high to low. 3¡¢ Requirements for temperature and humidity in dust-free workshops 1. Adapt to production process requirements. 2. When there are no special requirements for the production process, the temperature of a clean room (area) with air cleanliness levels of one hundred or ten thousand should be between 20 ¡æ and 24 ¡æ, and the relative humidity should be between 45% and 65%; The temperature of clean rooms (areas) with air cleanliness levels of 100000 and 300000 should be between 18 ¡æ and 26 ¡æ, and the relative humidity should be between 45% and 65%. When there are special requirements, they should be determined according to the process requirements. 3. The temperature of the personnel purification room should be between 16 ¡æ to 20 ¡æ in winter and 26 ¡æ to 30 ¡æ in summer. 4¡¢ Requirements for sterile testing rooms The dust-free workshop must be equipped with a sterile testing room with an independent purification air conditioning system (separate from the production area), which is required to be a local level 100 under 10000 level conditions. sterile |
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