9159金沙游戏场-9159金沙游戏艺场官网

  • 地址:济南市槐荫区鑫苑世家公馆2号楼2603室
  • 电话:0531-87568508 /
  • 手机:18653128690
  • 邮箱:jnyhrs@163.com
  • About药品研发实验室参数策划要点
    来源: 浏览:次 发布日期:2020-06-15
    1. 药品研发实验室按照研发课题的不同,其计划计划异议性显著,实验仪器设备的增加、实验众具的选用、通排风系统的配置都会对实验室计划策划带来改动。易于 对实验室的灵活性和上瞻性有一定要旨。
    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. 作为医药研发生产基地的必备场所,必须通过GMP认证。如涉及出口则要旨通过相应出口国的认证, 诸如出口欧洲需经过欧盟GMP认证,出口美国需要通过FDA认证,不同的认证体系对实验室建造均有具体要旨。
    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、药品研发中包含一项必备work:微生物项检测。不同的药品种类会对应不同的微生物检测porject,作为实验室装潢策划集团官网,需要和建造方做好对接,注明所要检测的药品种类,来设置功能用房。
    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、特殊药品制剂对实验室手工制作计划有特殊要旨, 诸如β-内酰胺类强致敏性药品、激素类药品、抗癌类药品等,实验室建造中对人员防护、废弃物处理、气流组织均有特殊要旨。
    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.
    环境参数的要旨
    空气净化工程
    Requirements for environmental parameters
    类是对功能间有温、湿度要旨的;指加速稳定性考察室、天平室、精密仪器室等。如加速稳定性考察室的环境参数一贯为:温度40℃,湿度75%;对天平室、精密仪器室主要是要旨除湿。
    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 75百分比; the balance room and precision instrument room are mainly required to be dehumidified.
    第二类是对功能间没有特殊要旨,只需要普通通风的;是指一般归纳实验区、work使用室等;毒气室则要旨有专用的排气装备设施;其他客厅则只要普通通风就行。
    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.
    第三类是对功能间有空气洁净度要旨的。指无菌检查室、微生物限度枪定室和抗生素微生物检定室等,策划中可按以下原则设置:
    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)无菌检查室、微生物限度检查室和抗生素微生物检定室,应分开设置;
    (1) Aseptic examination room, microbial limit examination room and antibiotic microorganism examination room shall be set up separately;
    (2)无菌检查室、微牛物限度检定室应为无菌洁净室,房间内部净化级别不应低于l万级,操作区应设置局部100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)对抗生素微生物检定室,其净化级别至少应为10万级。
    (3) The purification level of antibiotics microbiological laboratory should be at least 100000.
    感谢您的阅读与观看,本文的精彩始末来自:实验室装潢吾们会有更好优质的精彩始末继续为您呈现,详情请点击:
    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:
    XML 地图 | Sitemap 地图