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文章出处:Technology|阅读量:403|发表时间:2021-03-04
With the growth of world wealth and the aging of the population, people's emphasis on health and ability to pay has continued to increase, and more attention has been paid to the cure rate of diseases. In recent years, a variety of superbugs have frequently occurred worldwide, and the development of the biomedical industry has also accelerated. Overcoming difficult diseases and developing key drugs need to be completed by the biomedical industry. The research and development of new drugs is a key way to solve major problems related to the national economy and people's livelihood, and to solve major clinical diseases prevention and treatment. At this time, the new drug research and development laboratory, as the main building of new drug research and development, has assumed the responsibilities it must shoulder. As a laboratory construction company closely related to the pharmaceutical industry, CEIDI also deeply feels its responsibility. It is also the historical mission of every construction enterprise to build a modern, smart, energy-saving, safe and future-proof laboratory, and let all scientists conduct scientific research in a guaranteed laboratory.
Classification of medical laboratories:
1. According to the different functions of laboratories, it can be divided into drug research and development laboratories, quality control laboratories (QC laboratories), product control laboratories, drug testing laboratories, etc.
2. According to the different experimental scales, it can be divided into small-scale laboratory, pilot-scale amplification laboratory, pilot-scale workshop, etc.
3. According to the different types of drugs, it can be divided into chemical drug research and development laboratories, traditional Chinese medicine research and development laboratories, and biopharmaceutical research and development laboratories.
In fact, no matter how it is divided, a considerable proportion of the funds are used to establish advanced drug research and development laboratories. In this article, CEIDI Xidi will take the drug research and development laboratory as the theme to provide you with relevant knowledge of science: first we need to know . The important position of the pharmaceutical research laboratory in the design and construction and the problems that are prone to occur in the construction, a little carelessness will make all the later stages of the process fall short, and also consume a lot of research funds.
1. According to different subjects, the laboratory structure of drug research and development laboratories varies greatly, including the increase of instruments and equipment, the transformation of laboratory ventilation, and the increase or decrease of the location or quantity of laboratory equipment. Therefore, the laboratory has higher requirements for flexibility and foresight.
2. As part of the workshop, the QC laboratory must pass GMP certification. If the tested drugs are used for export, they need 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. The certification system has specific requirements for laboratory construction.
3. Drug testing includes microbiological item testing. The microbiological items that should be tested are different according to different types of drugs. Therefore, the construction of such laboratories must understand the types of drugs tested. For example, non-sterile preparations require microbiological limits for packaging materials. Detection, positive control experiment. In addition to the above two items, sterile drugs also need to undergo sterility testing, microbial identification, endotoxin testing, and antibiotic potency.
4. Special pharmaceutical preparations have special requirements for the layout of the laboratory process, such as β-lactam drugs, hormone drugs, anti-cancer drugs, etc., personnel protection, waste treatment, and airflow organization during laboratory construction All have special requirements.
The design of new drug research and development laboratories must comply with the scientific experiment building code (J GJ 9 1-93); the use functions, environmental requirements, and supporting facilities of each zone are different. In terms of its scale, conventional large-scale institutions will invest in the construction of R&D laboratories in the form of a complex, which mainly include office areas, warehouses, basic chemical laboratory areas, synthesis experimental areas, biological experimental areas, and clean areas (virus vaccine laboratories, Eukaryotic fermentation culture area, purification area, preparation and drug release experimental area, preparation filling, capping clean area, efficacy laboratory), analysis and testing center, animal room, pilot plant and other functional areas. Small-scale institutions will allocate functional partitions according to their research and development content.
CEIDI needs to remind everyone that the design and construction of the overall drug research and development laboratory must follow the principles of reasonable experimental procedures, clear functional area design distribution, unobstructed flow of people and goods, safe and convenient experimental operations, stable and reliable experimental platforms, and beautiful and practical principles. And must meet the requirements of the specification. For this type of project, CEIDI used to integrate and serve the project side in the EPC engineering mode. The EPC mode will closely integrate the overall project design and construction, internal supporting and other processes, which is more conducive to saving the entire project time cycle. And the cost of capital.