In order to strengthen the management of cleanroom garments in GMP workshops to ensure its safety, compliance and legality, as well as to further control the pollution risk in the production chain, Shanghai Jiabo Litong Technology Co., Ltd. monitors the use process of cleanroom garments in GMP workshops based on RFID technology and the closed-loop management system of cleanroom garments. The application of science and technology allows a convenient electronic traceability management for the storage, distribution, use, recycling, scrapping, cleaning, sterilization, usage time and whole life process of cleanroom garments. One-key query can trace all the use information of cleanroom garments.  The application of RFID technology on cleanroom garments can effectively reduce the statistical error possibility. From more than a dozen of customer feedback, it has achieved the purpose of the system design with a remarkable effect in improving personnel cleanroom garments management and risk control management of GMP workshop.

Xin Ke. Design and Implementation of Closed Loop Management System for GMP Workshop Cleanroom Garment. Academic Journal of Engineering and Technology Science (2024) Vol. 7, Issue 3: 152-157. https://doi.org/10.25236/AJETS.2024.070321.

[1] Hu Jinglu, Guo Jidong. The Application of Total Quality Management Theory in Pharmaceutical Management Work [J]. China Health Industry, 2022, 19 (4): 94-96.

[2] Wang Sijin, Wang Baobang, Yu Meng, etc. Personnel management in domestic and foreign guidelines for sterile drug production regulations [J]. Chinese Journal of Pharmaceutical Industry, 2022, 53 (8): 1222-1226.

[3] Ma Chaoqiong, Wen Lin, Li Dengke, etc. Research on Integrated Management of High Value Medical Consumables Supply Chain [J]. Medical and Health Equipment, 2019,40 (7): 81-85.

[4] Li Ying, Han Zijian. Developing a humid heat sterilization process using the principle of sterile assurance [J]. Strait Pharmacy, 2021, 33 (8): 6-9.

[5] Wang Xiao, Wang Lu, Gao Yongbao, etc. Analysis of inspection defects in factories, facilities, and equipment in the global pharmaceutical industry [J]. Chinese Journal of Modern Applied Pharmacy, 2020,37 (10): 1241-1247.

[6] Cui Juxia, Zhao Zhihong. Clean room control for sterile drug production [J]. Electromechanical Information, 2010 (26): 21-23, 52

[7] Wang Xin, Yan Huahui, Wang Hao, etc. Design and Application of Electronic Batch Records in the Pharmaceutical Industry [J]. Industrial Control Computer, 2019, 32 (8): 156-157+160.

[8] National Health Commission of the People's Republic of China. Good Manufacturing Practice for Drugs (Revised in 2010) (Order No. 79 of the Ministry of Health) [S]. 2011

[9] Li Zhike, Liu Zhusong. RFID tag data verification and recovery based on cloud storage technology [J]. Journal of Guangdong University of Technology, 2014 (3): 137-142.