Warmly congratulate DST Durst and Shanghai well-known radiopharmaceutical companies to reach a plant design project cooperation!
Release time:
2024-10-25
Durst DST has recently launched a cooperation project with a well-known radiopharmaceutical enterprise in Shanghai. The purpose of this project is to help the enterprise to review the QC laboratory (radioactive laboratory and non-radioactive laboratory), production workshop (including synthesis accelerator), hot room for synthesis and preparation, preparation room and other process sections of the whole factory in the design stage of the enterprise. At the same time, it also involves the warehouse management, public system design and management.
Durst DST has recently launched a cooperation project with a well-known radiopharmaceutical enterprise in Shanghai. The purpose of this project is to help the enterprise to review the QC laboratory (radioactive laboratory and non-radioactive laboratory), production workshop (including synthesis accelerator), hot room for synthesis and preparation, preparation room and other process sections of the whole factory in the design stage of the enterprise. At the same time, it also involves the warehouse management, public system design and management.
Because of the limitation of the property of radiopharmaceuticals, the design needs to be scientifically laid out in the design stage, especially the flow direction of personnel and articles in the workplace, the layout of source-related links, the relevant facilities of radiation safety, etc. should be designed according to the standard, and the production process including the planning and layout of source-related links should be carried out according to the process standard, therefore, radiopharmaceutical enterprises should carry out design audit in the design stage of the plant design and the team with rich experience in the production of radiopharmaceuticals, so as to ensure the compliance of the plant and facilitate the later management, reduce the later transformation and reduce the cost. DST DST has helped a number of companies to conduct radiopharmaceutical project counseling, the team has the corresponding radiopharmaceutical experience.
This time, DST Durst helped the enterprise to select the technical standard of the hot room simultaneously during the audit, and communicated with the design institute according to the corresponding situation. This time, the audit helped the company address a number of design risks and ensured compliance so that the company could later meet NMPA and FDA cGMP requirements.
DST DST team has been serving pharmaceutical companies for a long time. It has rich consulting service experience in the whole life cycle of pharmaceutical companies from plant design, plant construction, plant equipment acceptance, quality system construction, plant, equipment and facilities confirmation and verification, process verification, production, drug marketing license, domestic and international GMP certification, etc., and has successively provided consulting services to 100 pharmaceutical companies, for the plant design module, we have served Lizhu Biology, Beida Unnamed Biology, Chengdu Shengnuo Biology, Sichuan Xiantong Medicine, CNNC Hydewei, Zhuhai Taino Mabo, Rishpley, Yinuo Micro Medicine and other companies.
In addition, Durst takes the mission of enabling more pharmaceutical enterprises to reach the international top quality management level, the concept of customer first, and its own specialty as its hard strength. It focuses on serving international GMP consulting work, including FDA, EU-GMP, TGA, PIC/S, QP and other certification, audit and verification and confirmation of plant, facilities and equipment, public systems, etc. It has successively provided international GMP services for Lizhu Pharmaceutical, Baiyunshan Pharmaceutical, China Resources Sanjiu, North China Pharmaceutical, Kangtai Biology, Baiji Biology, Longsha Biology, Sinopharm Zhongsheng and other enterprises, and has been recognized by customers.
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Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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