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. 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. 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.
Requirements for environmental parameters
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.
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.
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) Aseptic examination room, microbial limit examination room and antibiotic microorganism examination room shall be set up separately;
(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) The purification level of antibiotics microbiological laboratory should be at least 100000.
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