On 17 March 2023, the State Administration for Market Regulation and the Standardization Administration of China issued China National Standard Announcement No. 21 of 2022, formally releasing GB/T 42398-2023 Technical Specification for the Design of Cell Culture Cleanrooms in the field of cleanrooms and associated controlled environments. The standard will take effect on 1 October 2023. As a leading enterprise in China's cell industry, Shenzhen Beike Biotechnology Co., Ltd. was invited to participate in drafting this national standard.
GB/T 42398-2023 Technical Specification for the Design of Cell Culture Cleanrooms
This document specifies the general requirements for the design of cell culture cleanrooms, including ventilation and purification, building envelopes, electrical and information systems, water supply and drainage, gas piping, and safety requirements.
This document applies to the design of cleanrooms used for cell culture intended for human application; other cell culture cleanrooms may be designed with reference to this document.
Standards provide the technical underpinning for economic activity and social development and are an important component of the country's foundational institutional framework. Standardization plays a foundational and guiding role in advancing the modernization of national governance systems and capabilities. The Outline for National Standardization Development, issued previously by the Central Committee of the Communist Party of China and the State Council, emphasizes that during the 14th Five-Year Plan period, China will build a national standards system that drives high-quality development, and will draft and refine standards relating to technology safety in fields such as biomedical research, molecular breeding, and autonomous driving in a timely manner, thereby raising the level of safety risk management in these technological domains. As an industry leader, Beike Biotech took the lead in 2016 in drafting the Shenzhen local standard SZDB/Z 188-2016 Construction and Management Specifications for Cell Preparation Centers, the first local standard in China for cell preparation centers. Building on this earlier standardization work and on many years of practical experience in standardization for cell-based biological products, Beike Biotech took an active role in drafting, researching, and developing GB/T 42398-2023 Technical Specification for the Design of Cell Culture Cleanrooms.
Environmental control is one of the key elements of quality management. Cell products in particular, being "living" biological products, are sensitive to even minor deviations that can affect final product quality. By incorporating the special requirements of cell products into the quality management system and standardizing the cleanroom – the critical environment in cell-product manufacturing – this standard can effectively raise the level of standardization in China's cell-based biopharmaceutical industry. As one of the earliest National High-Tech Enterprises in China specializing in the clinical translation and technical services of biotherapy technologies in strategic emerging industries, Beike Biotech has personally witnessed the development of China's cell industry. Over the years, the company has consistently placed great importance on the standardization of cell products, having participated in dozens of national, local, and industry standards covering many areas of the cell industry. Beike Biotech will continue to contribute to standardization work for the cell industry in the years ahead.
