Zhejiang Class III Medical Device GMP Class 10,000 Clean Workshop Decoration_

The three types of medical devices implanted and intervened into blood vessels require subsequent processing (such as filling and sealing, etc.) in the local class 100 clean area under class 10,000. ) The processing of spare parts, final cleaning, assembly, initial packaging and sealing and other production areas should not be lower than 10,000 cleanliness level. Let's take a look at the decoration case of sz-pharma's three types of medical pharma machinery class 10,000 (partial class 100) . Project Overview: Three types of medical equipment Project construction contractor: Shanghai Leijian Building Decoration Engineering Co., Ltd. Project Address: Zhejiang pharmaceutical cleanroom Decoration Grade: 10,000-level, local 100-level Construction area: about 2800 square meters of medical equipment The temperature and relative humidity of the (room) should be adapted to the requirements of the pharmaceutical production process. If there are no special requirements, the temperature should be controlled at 18-26ºC, and the relative humidity should be controlled at 45-65%. The decoration design of the clean room of medical pharma machinery should pay attention to the distribution of functions, personnel change clothes and wash hands, and materials are passed in and out. Air conditioning system design, pure water system design. Floor: self-leveling floor with grass-loop resin Wall and partition: if cotton color steel with composite board partition Ceiling: Bozan color steel clip board self-top Color steel airtight doors and windows. The layout design of the (room) should pay attention to the following aspects: 1. Layout according to the production process flow. The process is as short as possible, the cross-reciprocation is reduced, and the flow of people and logistics is reasonable. It must be equipped with personnel clean room (coating room, washroom, room for wearing clean work clothes and buffer room), material clean room (outsourcing room, buffer room and double-layer transfer window). Equipped with sanitary ware room, laundry room, temporary storage room, station utensil cleaning room, etc., each room is independent of each other, and the area of ​​the should be adapted to the production scale under the premise of ensuring the basic requirements. 2. According to the air cleanliness level, it can be written as the direction of the flow of people, from low to high; the pharmaceutical cleanroom is from the inside to the outside, from high to low. 3. There is no cross pollution in the same clean room (area) or between adjacent clean rooms (areas) 1) The production process and raw materials will not affect the quality of the product; 2) Between different levels of clean rooms (areas) There are air lock chambers or anti-pollution measures, and the material is conveyed through double-layer transfer windows. 4. Air purification should comply with GB

50457-2008 Requirements of Chapter 9 of 'Code for Design of Clean Plants in Pharmaceutical Industry'. The fresh air volume in the clean room should take the following maximum values: 1) Compensate the indoor exhaust air volume and the fresh air volume required to maintain positive indoor pressure; 2) The fresh air in the room should not be less than 40 cubic meters per hour. 5. The per capita area of ​​the clean room should be no less than 4 square meters (except corridors, pharma machinery and other items) to ensure a safe operating area. 6. The direction of the return air, supply air and water pipes should be marked. decoration Scan the QR code pattern below, add me on WeChat, get a free design quote

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