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Biomedicine Dust-free GMP purification workshop design and construction experience CEIDI

文章出处:Technology|阅读量:366|发表时间:2021-03-04

As early as the 2017 Pharmaceutical Market Report predicted that in the next 5 years, the global prescription drug market will grow steadily at a compound growth rate of 6.5%, of which biological products will account for 30% of the pharmaceutical market, reaching US$326 billion. The huge market potential indicates that the pharmaceutical market is destined not to be unknown. By 2020, the attack of the virus of the century will make the pharmaceutical industry take on more historical missions. How to decorate the GMP purification workshop closely related to the pharmaceutical industry? This problem is a common question in the early stage of companies engaged in biomedicine. Because the production of pharmaceutical products and equipment products of biomedical companies must be produced in GMP laboratories, and the clean environment of the entire production area has strict standards. The goal of GMP is to ensure the establishment of a scientific and strict sterile drug production environment, process, operation and management system, to eliminate all possible and potential biological activity, dust, and heat source pollution to the greatest extent, and to produce high-quality, hygienic and safe products. Drug products. The construction of high-standard GMP laboratories is the basis for the effective operation of pharmaceutical companies. This article discusses and researches the design and construction of the GMP laboratory of Zhongxin Tang Guoye based on CEIDI Xidi’s design and construction.

Zhongxin Tang Guoye (Suzhou) Technology Co., Ltd. is a professional company specializing in the research and development, production and operation of biomedical materials, especially oral medical materials and related equipment. It is owned by The University of Sheffield and Peking University. , Harbin Institute of Technology and a professional dental materials R&D team composed of related research institutes. CEIDI Xidi provides full EPC services for the design and construction of its 3000㎡ dust-free GMP purification workshop in Taicang, Jiangsu.

For the biopharmaceutical industry, the construction of a GMP clean room is the primary prerequisite and mandatory standard for all work. The working principle of the purification workshop is mainly realized through air filtration. Generally, there are three stages of primary filtration, intermediate filtration and high-efficiency filtration. The airflow enters the humidification section → heating section → surface cooling section → medium-efficiency purification → fan air supply → pipes → high-efficiency purification air outlets → blow into the room → take away dust and bacteria and other particles → return air shutters → initial purification.

A GMP laboratory with a cleanliness level of 10,000 has high standards and requirements for the design and construction parties. Because of the rigorous production requirements of its industry and products, conventional decoration design companies are naturally unable to undertake such high-standard projects. As a CEIDI with 12 years of laboratory design and construction experience, its high-quality EPC engineering integration service provider status is the best choice for building such GMP purification workshops. For this kind of purification workshop, CEIDI Xidi will choose matching building materials in wall, floor, ceiling decoration engineering, door and window decoration engineering, and the relevant material configuration is as follows:

1. Laboratory wall

1) Sandwich color steel plates are used for the partition walls of the work area;

2) All internal corners of the wall of the room in the working area are rounded R≥50, and all external corners of the wall of the room are made of small rounded corners;

3) The combination of the wall and the ceiling of the working area of the GMP laboratory is an arc structure, the wall and ceiling are made of sandwich color steel plate, and the part against the outer wall is decorated with a light brick wall;

2) PVC board skirting line is used in the working area, the internal corners of the wall and the ground are rounded R≥50, and the skirting height is 120.

2. Laboratory ground

1) The working area adopts homogeneous permeable PVC floor with a thickness of 2.0m;

2) When the color of the floor and floor of the room is different, the door of the room is the dividing line.

3. Laboratory ceiling decoration project

1) The ceiling of the working area of the GMP microbiology laboratory is made of sandwich color steel plate, and the wet area is made of 300*300 aluminum buckle ceiling;

2) The ceiling height of the GMP microbiology laboratory is designed to be 2.6 meters, and the ceiling height of each area is subject to the actual allowable height on site;

3) For all rooms with suspended ceilings, the specifications of lamps, installation positions, air outlets, smoke detectors, and alarm installation positions should be determined according to the ceiling specifications and arrangement, combined with a professional drawing.

4. Laboratory door and window decoration project

All doors in the area are made of aluminum alloy door frames, with fireproof panels on the surface, and aluminum alloy edging.

In terms of spatial layout, CEIDI designers will combine the industry characteristics of the company, the company’s own technological development prospects, and the particularity of the address location. The design will be carried out after sufficient research in the early stage, and effective measures will be taken to rationally arrange the flow of people and logistics. And supporting functions to prevent cross-contamination, while also considering the future development needs of the enterprise. CEIDI has enough industry experience in the field of laboratories and clean rooms. It also uses its own industrial chain advantages to set up its own production base in Taizhou, Jiangsu, and continuously builds various kinds of laboratory furniture and materials for various projects. To truly allow enterprises to carry out projects without worries, and to save manpower, material resources and project costs for enterprises, it reflects the unique advantages of CEIDI. The biomedical industry has become a new engine for global economic development. As a laboratory and clean engineering construction expert, CEIDI has the most valued laboratory and clean engineering design and construction experience. It has cultivated the Yangtze River Delta region for more than ten years. We are committed to creating laboratories and clean rooms with complete hardware and software for enterprises. It is a high-quality partner of my country's biomedical enterprises.

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