On 17 March 2023, the State Administration for Market Regulation and the Standardization Administration of China issued the No. 21 China National Standard Announcement of 2022, in which the cleanroom and related controlled environments national standard GB/T 42398-2023 "Technical Code for the Design of Cell Culture Cleanrooms" was officially released and will come into force on 1 October 2023. As a leading enterprise in China's cell industry, Shenzhen Beike Biotechnology Co., Ltd. was invited to participate in the drafting and formulation of this national standard.
GB/T 42398-2023 "Technical Code for the Design of Cell Culture Cleanrooms"
This document specifies the general requirements for cell culture cleanroom design, ventilation and purification, the building envelope, electrical and IT systems, water supply and drainage, gas pipelines and safety requirements.
This document applies to the design of cleanrooms for cell culture intended for use in the human body; other cell culture cleanrooms may refer to this document.
Standards are a technical underpinning of economic activity and social development and an important aspect of the country's basic institutional framework. Standardization plays a fundamental and leading role in advancing the modernization of national governance systems and capabilities. Earlier, the Central Committee of the Communist Party of China and the State Council issued the "Outline for the Development of National Standardization", which emphasized that, during the "14th Five-Year Plan" period, in order to drive a national standards system that supports high-quality development, technical-safety-related standards in such areas as biomedical research, molecular breeding and autonomous driving must be formulated and improved in a timely manner, raising the level of safety risk management in technological fields. As a sector leader, Beike Biotech took the lead in 2016 in drafting and formulating the Shenzhen local standard "SZDB/Z 188-2016 Code for the Construction and Management of Cell Preparation Centers", China's first local standard for cell preparation centers. Building on this previous standardization experience and on years of practical experience in standardization in the cell biological products sector, Beike Biotech was deeply involved in the drafting, research and formulation of the GB/T 42398-2023 "Technical Code for the Design of Cell Culture Cleanrooms" national standard.
The environment is one of the key elements of quality management. In particular, since cell products are "living" biological products, even small deviations can affect the final product quality. Therefore, when designing the quality management system, regulating the cleanroom – a key location in the production environment of cell products – in line with the special requirements of cell products can effectively raise the level of standardization of China's cell biopharmaceutical industry. As a National High-Tech Enterprise that was among the first in China to specialize in the clinical translation and technical service of biotherapeutic 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 a high priority on the standardization of cell products, having cumulatively participated in dozens of standards of various types – national, local and industry – covering many areas of the cell industry. Going forward, Beike Biotech will continue to contribute its corporate strength to standards work in the cell industry.
