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  • 關于藥品研發實驗室參數設計要點
    來源:http://www.nexregen.com 瀏覽: 發布日期:2020-06-15
    1. 藥品研發實驗室根據研發課題的不同,其規劃布局差異性顯著,實驗儀器設備的增加、實驗家具的選用、通排風系統的配置都會對實驗室規劃設計帶來改變。因此對實驗室的靈活性和前瞻性有一定要求。
    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. 作為醫藥研發生產基地的必備場所,必須通過GMP認證。如涉及出口則要求通過相應出口國的認證,例如出口歐洲需經過歐盟GMP認證,出口美國需要通過FDA認證,不同的認證體系對實驗室建設均有具體要求。
    2. As a necessary place for pharmaceutical R &amp; 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、藥品研發中包含一項必備工作:微生物項檢測。不同的藥品種類會對應不同的微生物檢測項目,作為實驗室裝修設計公司,需要和建設方做好對接,注明所要檢測的藥品種類,來設置功能用房。
    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、特殊藥品制劑對實驗室工藝布局有特殊要求,例如β-內酰胺類強致敏性藥品、激素類藥品、抗癌類藥品等,實驗室建設中對人員防護、廢棄物處理、氣流組織均有特殊要求。
    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.
    環境參數的要求
    空氣凈化工程
    Requirements for environmental parameters
    類是對功能間有溫、濕度要求的;指加速穩定性考察室、天平室、精密儀器室等。如加速穩定性考察室的環境參數通常為:溫度40℃,濕度75%;對天平室、精密儀器室主要是要求除濕。
    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.
    第二類是對功能間沒有特殊要求,只需要普通通風的;是指一般分析實驗區、辦公室等;毒氣室則要求有專用的排氣設施;其他房間則只要普通通風就行。
    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.
    第三類是對功能間有空氣潔凈度要求的。指無菌檢查室、微生物限度槍定室和抗生素微生物檢定室等,設計中可按以下原則設置:
    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)無菌檢查室、微生物限度檢查室和抗生素微生物檢定室,應分開設置;
    (1) Aseptic examination room, microbial limit examination room and antibiotic microorganism examination room shall be set up separately;
    (2)無菌檢查室、微牛物限度檢定室應為無菌潔凈室,室內凈化級別不應低于l萬級,操作區應設置局部100級單向流裝置;
    (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)對抗生素微生物檢定室,其凈化級別至少應為10萬級。
    (3) The purification level of antibiotics microbiological laboratory should be at least 100000.
    感謝您的閱讀與觀看,本文的精彩內容來自:實驗室裝修我們會有更多的精彩內容繼續為您呈現,詳情請點擊:http://www.nexregen.com
    Thank you for reading and watching. The highlights of this article come from: we will continue to present more highlights for you in the laboratory decoration. For details, please click: http://www.nexregen.com
    相關標簽: 空氣凈化工程、實驗室裝修、無菌室裝修、
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