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  • 医疗器械净化车间设计应该注意什么?
    来源:最新澳门网址大全 浏览: 发布日期:2020-09-21
    1、按生产工艺流程布置。流程尽可能短,减少交叉往复,人流、物流走向合理。必须配备人员净化室(存外衣室、盥洗室、穿洁净工作服室及缓冲室)、物料净化室(脱外包间、缓冲室和双层传递窗),除配备产品工序要求的用室外,还应配备洁具室、洗衣间、暂存室、工位器具清洗间等,每间用室相互独立,洁净车间的面积应在保证基本要求前提下,与生产规模相适应。
    1. According to the production process. The process should be as short as possible to reduce cross reciprocating, and the flow of people and logistics should be reasonable. It must be equipped with personnel purification room (coat storage room, washroom, clean work clothes room and buffer room), material purification room (unpacking room, buffer room and double-layer transfer window). In addition to the room required for product process, it should also be equipped with sanitary ware room, laundry room, temporary storage room, cleaning room for working equipment, etc. each room is independent of each other, and the area of clean workshop should be guaranteed to be basic Under the premise, it is suitable for the production scale.
    2、按空气洁净度级别,可以写成按人流方向,从低到高;车间是从内向外,由高到低。
    2. According to the air cleanliness level, it can be written from low to high according to the direction of people flow; the workshop is from inside to outside, from high to low.
    3、同一洁净室(区)内或相邻洁净室(区)间不产生交叉污染生产过程和原材料不会对产品质量产生相互影响;不同级别的洁净室(区)之间有气闸室或防污染措施,物料的传送通过双层传递窗。
    3. There is no cross contamination in the same clean room (area) or between adjacent clean rooms (areas). The production process and raw materials will not affect the product quality; there are airlocks or anti pollution measures between clean rooms (areas) of different levels, and materials are transported through double-layer transfer windows.
    空气净化工程
    4、空气净化应符合GB 50457-2008《医药工业洁净厂房设计规范》第九章的要求。洁净室里的新鲜空气量,应取下列大值:
    4. The air purification should meet the requirements of Chapter 9 of GB 50457-2008 code for design of clean workshop in pharmaceutical industry. The amount of fresh air in the clean room should be taken as follows:
    1)补偿室内排风量和保持室内正压所需新鲜空气量;
    1) Compensation of indoor exhaust air volume and fresh air volume required for keeping indoor positive pressure;
    2)室内没人新鲜空气不应小于40m3/h。
    2) When there is no one in the room, the fresh air should not be less than 40m3 / h.
    5、净化车间人均面积应不少于4mm(除走廊、设备等物品外),保证操作区域。
    5. The per capita area of purification workshop shall not be less than 4mm (except for corridor, equipment and other items) to ensure the operation area.
    6、如属体外诊断试剂的应符合《体外诊断试剂生产实施细则(试行)》的要求。其中阴性、阳性血清、质粒或血液制品的处理操作应当在至少万级环境下进行,与相邻区或保持相对负压,并符合防护要求。
    6. If it is an in vitro diagnostic reagent, it shall meet the requirements of the implementation rules for in vitro diagnostic reagent production (Trial). Among them, the treatment of negative and positive serum, plasmid or blood products should be carried out in an environment of at least ten thousand level, keep relative negative pressure with the adjacent area, and meet the protection requirements.
    7、应标明回风、送风及制水管道的走向。
    7. The direction of return air, supply air and water supply pipeline shall be indicated.
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