Abstract：Objective To analyze the difference of gas sterilization quality standards between Chinese pharmacopoeia and foreign pharmacopoeia and reflect on the current situation, exploring the means to improve gas sterilization quality standards of Chinese Pharmacopoeia. Methods The gas sterilization quality standards of Chinese Pharmacopoeia were compared with those in United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia, at the same time referring to other literatures and investigating enterprises. Results The Chinese Pharmacopoeia and the foreign Pharmacopoeia are consistent with the overall requirements for quality control of gas sterilization, but there are still some differences in some aspects, such as the definition and scope of gas sterilization, the types of strains of biological indicators and coding, physicochemical indicators classification and anomaly description, verification methods, analysis and detection of sterilant residues, which need to be gradually improved through adequate technical evaluation and feasibility analysis. In addition, the gap in hardware level of most enterprises in China is relatively high. Obviously, the use of gas concentration probes, the circulatory system of sterilizing cabinets and the establishment of thermal desorption chambers are largely due to the constraints of enterprise costs and development concepts. Conclusion According to the actual situation in China, we should further revise the gas sterilization quality standards of Chinese Pharmacopoeia. Using promotion of quality standards, we can improve the thinking mode and the concept of enterprises, and optimize the technology and boost the level of industry.
刘洪祥 李娅男 曹晓云 郭福庆. 中国药典气体灭菌法质量标准的分析与现状思考[J]. 中国抗生素杂志, 2020, 45(08): 733-737.
Liu Hong-xiang, Li Ya-nan, Cao Xiao-yun Guo Fu-qing. Analysis and reflection on gas sterilization quality standards of Chinese Pharmacopoeia. CJA, 2020, 45(08): 733-737.