GB/T 43459-2023Technical specification for cell culture operations in cleanroom and relevant controlled environment (English PDF)

Foreword

This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting:

Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:

This document is proposed and coordinated by the National Standardization Technical Committee for Clean Rooms and Controlled Environments (SAC/TC319):

This document was drafted by: Institute of Zoology, Chinese Academy of Sciences, Beijing Technology and Business University, Institute of Military Medicine, Academy of Military Sciences, China Agricultural University Science, China Association for Standardization, East China University of Science and Technology, China Medical Biotechnology Association, Beijing Institute of Stem Cells and Regenerative Medicine, Suzhou Antai Air Technology Co:, Ltd:, Fachen Pharmaceutical System Engineering (Shanghai) Co:, Ltd:, Beijing Beilai Pharmaceutical Co:, Ltd:, Shandong Taihong Biotechnology Development Exhibition Co:, Ltd:, Kunming Yan'an Hospital, Shanghai Indoor Environment Purification Industry Association, Zhejiang Huayuan Environmental Engineering Co:, Ltd:, Tianjushi Engineering Technology Group Co:, Ltd:, Hangzhou Boyue Biotechnology Co:, Ltd:, Pionil Environmental Purification Engineering (Beijing) Co:, Ltd:, Hefei Zhongke Popularization Ruisheng Biomedical Technology Co:, Ltd:, Shanghai Saiao Biotechnology Co:, Ltd:, Tangyi Holdings (Shenzhen) Co:, Ltd:, Zhejiang Tailin Biotechnology Technology Co:, Ltd:, Devin Engineering Design (Shanghai) Co:, Ltd:, Beijing Biopsis Biotechnology Co:, Ltd:, Shanghai Shanghai Experimental Experiment Laboratory Equipment Co:, Ltd:, Shenzhen Saidong Intelligent Manufacturing Technology Co:, Ltd:, Ximai (Shanghai) Testing Technology Service Co:, Ltd:, Shanghai Food and Drug Product Packaging Materials Testing Institute, Dongfulong Life Technology Co:, Ltd:, Shanghai Danrui Biomedical Technology Co:, Ltd:, Shenzhen Beike Biotechnology Co:, Ltd:, Beijing Sambo Technology Co:, Ltd:

The main drafters of this document: Ma Aijin, Zhang Yi, Wu Zhaohui, Wang Jian, Zhao Tongbiao, Cai Haibo, Wang Fang, Hao Yinbo, Hou Zongliu, Shao Xiaoyan, Liu Yongjun, Han Jianyong, Wang Kun, Wei Jiaming, Luo Liping, Li Ang, Wu Zhijian, Xu Xueqiang, Zhao Juan, Huang Yu, Cao Jiani, Hao Jie, Li Siting, Liu Muyun, Chen Yiding, Xu Shaokun, Song Xiaohui, Lu Dengfeng, Song Jinhui, Cheng Jinsheng, Wu Junjian, Sun Weiqun, Wang Lei, Liang Xiao, Li Yinlai, Chen Cheng, Hao Shuai:

Cell culture operations in clean rooms and controlled environments specifications

1 Scope

This document specifies the requirements for mammalian cell culture operations in clean rooms and controlled environments and describes the corresponding verification methods:

This document is applicable to mammalian cell culture in clean rooms and controlled environments:

2 Normative reference documents

GB/T 25915

3 Terms and definitions

The following terms and definitions apply to this document: 3:1 cell culturecelculture The process of allowing cells to survive, grow, proliferate and maintain their biological properties and functions: 3:2 expansionexpansion The process of increasing the number of cells in cell culture: 3:3 Passage The process of re-culturing to provide larger growth space for cell growth:

4 Requirements

4:1 Environmental protection 4:1:1 An operation system should be established in accordance with the requirements of GB/T 25915:5, including risk control, personnel training, clean clothing, personnel behavior, indoor objects Clean room operation specifications in terms of flow, daily cleaning, etc:

4:1:2 An automatic detection system for controlled environments such as cleanliness, temperature and humidity, and pressure difference should be established: 4:2 Preparation 4:2:1 Controlled environments such as ultra-clean workbenches/biological safety cabinets/isolators should be disinfected with ultraviolet light or hydrogen peroxide before performing culture operations:

4:2:2 Reagents and consumables required for cell culture should be prepared, including but not limited to culture medium, physiological buffer solution (PBS), culture containers, etc:

4:2:3 The outer packaging of experimental supplies and reagent consumables should be wiped with a suitable disinfectant (such as 75% ethanol):