On March 17, 2023, the State Administration for Market Regulation and the National Standardization Administration Committee issued China National Standard Announcement No. 21 of 2022, in which the national standard GB/T 42398-2023 “Technical Specification for Design of Cell Culture Clean Rooms” in the field of clean rooms and related controlled environments was officially released and will be implemented on October 1, 2023. Shenzhen Beike Biotechnology Co., Ltd., as a leading company in the domestic cell industry, was invited to participate in the drafting and formulation of this national standard.
GB/T 42398-2023 “Technical Specifications for Design of Cell Culture Clean Rooms”
This document specifies the general requirements for cell culture clean room design, ventilation and purification, enclosure structure, electrical and information technology, water supply and drainage, gas pipelines, and safety requirements.
This document is applicable to the design of clean rooms for cell culture used in the human body. Other cell culture clean rooms can refer to this document.
Standards are the technical support for economic activities and social development, and are an important aspect of the country’s basic system. Standardization plays a fundamental and leading role in promoting the modernization of the national governance system and governance capabilities. Previously, the Central Committee of the Communist Party of China and the State Council issued the “National Standardization Development Outline”, which emphasized that the national standards system to promote high-quality development during the “14th Five-Year Plan” period must timely formulate and improve technical safety-related standards in the fields of biomedical research, molecular breeding, driverless driving, etc., and improve the level of safety risk management in the technical field. As a leader in the industry, Beike Biotech took the lead in drafting and compiling the Shenzhen local standard – “SZDB/Z 188-2016 Construction and Management Specifications for Cell Preparation Centers” in 2016. This is my country’s first local standard for cell preparation centers. Based on Beike Bio’s previous experience in standardization construction and years of practical experience in standardization in the cell biological products industry, Beike Bio has been deeply involved in the drafting, research and formulation of the national standard GB/T 42398-2023 “Technical Specifications for Design of Cell Culture Clean Rooms”.
The environment is one of the key elements of quality management. In particular, cell products are “living” biological products, and any small deviation will have an impact on the quality of the final product. Therefore, when designing the quality management system, combining the special requirements of cell products and standardizing clean rooms in key locations in the cell product production environment can effectively improve the standardization of my country’s cell biomedicine industry. As one of the earliest national high-tech enterprises in China specializing in the clinical transformation and technical services of biotherapeutic technologies in strategic emerging industries, Beike Biotech has experienced the development of China’s cell industry. Over the years, it has always attached great importance to the standardization of cell products. It has participated in dozens of national standards, local standards, industry standards and other standards, covering multiple fields of the cell industry. In the future, it will continue to contribute to the standard work of the cell industry.