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文章出处:Enterprise|阅读量:815|发表时间:2021-02-25
The production process of medical products must be rigorous, there must be no deviations, and must be accurate and scientific. Therefore, for production facilities that undertake medical functions, ensuring the high standard operation of various functional laboratories is the basic basis for the standard production of medical products . The requirements of GLP laboratories in all aspects are relatively high. Therefore, compared with other types of laboratories, there are not many GLP laboratories in my country, even in Shanghai, which has strong scientific research capabilities. Because GLP laboratories carry special commodity forms such as "drugs", the requirements for laboratory research and development, design, and construction are "nearly harsh" from some perspectives. The GLP-certified laboratories of the State Food and Drug Administration are unevenly distributed, mostly in Beijing, Shanghai, Jiangsu, Shandong, Chengdu and Guangzhou. Frontage Pharmaceuticals is an all-round integrated pharmaceutical research and development contract research organization (CRO). It added Frontage Pharmaceutical Technology (Shanghai) Co., Ltd. in 2006. It is the first GLP laboratory established and operated in accordance with the US FDA standards in China.
GLP (Good Laboratory Practice) is the quality management practice of a good laboratory. The laboratory used in non-clinical safety evaluation research of drugs, its purpose is to improve the quality of non-clinical safety evaluation research of drugs (i.e. toxicology research), and to ensure the authenticity, integrity and reliability of experimental data. Exclude the impact caused by accidental errors to the extent, find and correct such errors as soon as possible, and correct and investigate their causes afterwards. The basic spirit of GLP lies in how to reduce human error, in order to obtain reliable experimental data, to ensure the safety of people's medication.
On January 8, 2019, CEIDI Xidi and Fangda Pharmaceutical completed the design contract. In just 20 days, the two key links of design finalization and construction contract were completed. As a result, CEIDI Xidi fully launched the Fangda Medicine Lab+Office renovation project located in the Zhangjiang R&D Center of the Academy of Military Medical Sciences.
According to the contract, the CEIDI Xidi project team formally entered the site on January 19 to start the demolition of the original laboratory. The available floor tiles and external image maintenance were retained, and the color steel plate wall demolition, glass partition demolition, and mineral wool board were completed. And the removal of gypsum board ceiling, PVC floor and floor removal, and the removal of panel lights and lamps. After that, it quickly entered the stage of the decoration and fitting-out project of the laboratory & office area on the first and second floors. The designers of CEIDI use the main color matching with the GLP laboratory, and take into account the simple aesthetic concept with the level of brightness, the bias of cold and warm, and the small decorations of local high chroma. In the selection of materials such as indoor interfaces and furnishings, we fully consider the characteristics of close distance, long-term visual comfort, skin contact and other characteristics of working researchers, and configure safe, environmentally friendly and ergonomic laboratory consumables.
The designer of the CEIDI Xidi task force said: A practical GLP laboratory should follow the flow of people's diversion and make a clear division plan to prevent mutual contamination. In terms of functional division, in addition to the standard "preparation room", "washing room", "sterilization room" and "sterile room", we have also configured enough storage space for the storage of test products and archives. In order to meet the needs of drug research and development, the laboratory temperature should be controlled at 20±3℃, the relative humidity should be 30% to 70%, and the air should be circulated and filtered, and the light should be 12h.
It is reported that the project was successfully delivered in May of the same year. CEIDI Xidi used the EPC (General Engineering Contracting) model throughout the entire process to advance the project progress. Realize the deep integration of design, procurement, construction, and trial operation, and fully improve the efficiency of engineering construction. Effectively solve the problems of long approval period for each link of bidding and bidding from project design to construction, poor connection between design and construction, and uncontrollable investment scale. Fangda Pharmaceutical also expressed its affirmation of the early design, high-quality coordination, response speed, price configuration, and engineering quality of the personnel of the CEIDI Xidi task force.