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  • 关于药pinyan发bet体育下载室参数设计yao点
    laiyuan:http://www.jnyhrs.com 浏览:ci 发布日期:2020-06-15
    1. 药pinyan发bet体育下载室根据yan发课ti的不tong,其规划布局差异性显著,bet体育下载yi器设备的zeng加、bet体育下载家具的选用、通排风系统的配置都会duibet体育下载室规划设计带lai改变。因ciduibet体育下载室的灵活性和前瞻性有一定yaoqiu。
    1. According to the different research and development projects, the planning and layout of drug research and development laboratory are significantly different. The increase of experimental equipment, the selection of experimental furniture, and the configuration of ventilation system will change the planning and design of the laboratory. Therefore, there are certain requirements for the flexibility and foresight of the laboratory.
    2. zuo为医药yan发生chan基地的bi备chang所,bixu通guoGMP认证。如she及出口则yaoqiu通guo相ying出口国的认证,li如出口舊en扌鑚ingguo欧盟GMP认证,出口美国需yao通guoFDA认证,不tong的认证体系duibet体育下载室建设均有具体yaoqiu。
    2. As a necessary place for pharmaceutical R & D and production base, it must pass GMP certification. If the export is involved, it is required to pass the certification of the corresponding exporting country. For example, the export to Europe needs to pass the EU GMP certification, and the export to the United States needs to pass the FDA certification. Different certification systems have specific requirements for laboratory construction.
    3、药pinyan发zhong包含一项bi备工zuoe⑸锵罴靋e。不tong的药苀en掷嗷醖uiying不tong的微生物检ce项目,zuo为bet体育下载室装xiu设计公si,需yao和建设fang做好duijie,注明所yao检ce的药苀en掷啵琹ai设置gong能用房。
    3. Drug research and development includes a necessary work: microbiological test. Different types of drugs will correspond to different microbial detection items. As a laboratory decoration design company, it needs to make a good connection with the construction party, indicate the types of drugs to be tested, and set up a functional room.
    4、特殊药苀en萍羋uibet体育下载室工艺布局有特殊yaoqiu,li如β-内xian胺类强致敏性药pin、激素类药pin、抗癌类药pin等,bet体育下载室建设zhongdui人yuan防护、feiqi物处理、气流组织均有特殊yaoqiu。
    4. Special pharmaceutical preparations have special requirements for laboratory process layout, such as β - lactam strong sensitizing drugs, hormone drugs, anticancer drugs, etc. in laboratory construction, there are special requirements for personnel protection, waste treatment, air distribution.
    环jing参数的yaoqiu
    空气净化工程
    Requirements for environmental parameters
    类是duigong能jian有wen、湿度yaoqiu的;指加速wen定性kao察室、天平室、精密yi器室等。如加速wen定性kao察室的环jing参数通常为:wen度40℃,湿度75%;dui天平室、精密yi器室主yao是yaoqiu除湿。
    The first type requires temperature and humidity between functions; it refers to acceleration stability inspection room, balance room, precision instrument room, etc. For example, the environmental parameters of the accelerated stability inspection room are usually: temperature 40 ℃, humidity 75%; the balance room and precision instrument room are mainly required to be dehumidified.
    第二类是duigong能jian没有特殊yaoqiu,只需yao普通通风的;是指一般fen析bet体育下载区、办公室等;毒气蕐i騳aoqiu有专用的排气设施;其他房jian则只yao普通通风就xing。
    The second is that there is no special requirement for the functional room, only ordinary ventilation is required; it refers to the general analysis and experiment area, office, etc.; the gas room requires special exhaust facilities; other rooms only need ordinary ventilation.
    第三类是duigong能jian有空气洁净度yaoqiu的。指无jun检查室、微生物限度枪定室和抗生素微生物检定室等,设计zhong可按yi下yuan则设置:
    The third type is the air cleanliness requirements for functional rooms. It refers to sterility test room, microbial limit gun test room and antibiotic microbial test room, etc., which can be set according to the following principles in the design:
    (1)无jun检查室、微生物限度检查室和抗生素微生物检定室,yingfenkai设置;
    (1) Aseptic examination room, microbial limit examination room and antibiotic microorganism examination room shall be set up separately;
    (2)无jun检查室、微牛物限度检定室ying为无jun洁净室,室内净化级别不ying低于l万级,操zuo区ying设置局bu100级单向流装置;
    (2) The sterility examination room and the micro cattle limit examination room shall be sterile clean room, the indoor purification level shall not be lower than 10000 level, and the operation area shall be equipped with local 100 level one-way flow device;
    (3)dui抗生素微生物检定室,其净化级别至少ying为10万级。
    (3) The purification level of antibiotics microbiological laboratory should be at least 100000.
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