摘要
目的 通过统计过程控制(Statistical Process Control,SPC),系统分析Fastlab 2自动合成系统在氟[^(18)F]脱氧葡萄糖([^(18)F]FDG)实际生产中的产率波动,识别关键影响因素,并提出具体可操作的质量优化建议。方法 回顾性分析贵州省人民医院核医学科近3个月内43批次[^(18)F]FDG的生产数据,并采用X-bar与R控制图对产率进行SPC评估,结合变异系数(Relative Standard Deviation,RSD)评估波动性,并对3次失败批次(产率0)及3次低产率批次(<40%)进行参数溯源(如真空压力、水解温度、操作合规性)。结果 Fastlab 2系统成功率为93.02%,成功批次(排除3次0产率失败批次)产率为31%~91%,平均产率为81.6%,RSD为18.64%。X-bar图与R图显示大部分批次处于控制限内,整体生产过程稳定,但局部批次因真空压力异常(如190 mbar vs.标准600 mbar)、水解温度过高(93℃vs.标准85~88℃)及操作偏差(卡套安装不到位、未执行水袋检查)导致产率波动。失败批次主要与设备真空故障(2次)、操作失误(1次)相关。结论 Fastlab 2系统具有良好的自动化合成能力,但产率波动仍需关注。通过优化设备的启动流程确认、改进试剂卡套的安装流程、加强操作人员的培训及规范实验环境管理,可有效地提升系统的一致性与生产成功率,为同类放射性药物生产单位提供可参考的优化路径。
Objective To systematically analyze the yield fluctuations of the Fastlab 2 autosynthesis system in the actual production of fluorine[^(18)F]deoxyglucose([^(18)F]FDG)through statistical process control(SPC),and identify the key influencing factors and put forward specific and operational quality optimization suggestions.Methods A retrospective analysis was conducted on the production data of 43 batches of[^(18)F]FDG in the Department of Nuclear Medicine of Guizhou Provincial People’s Hospital within the recent 3 months.The production rate was evaluated by SPC using X-bar and R control charts,and the volatility was evaluated by combining the relative standard deviation(RSD).Parameter traceability(such as vacuum pressure,hydrolysis temperature,and operational compliance)was conducted for the three failed batches(with a yield of 0)and the three low-yield batches(<40%).Results The success rate of the Fastlab 2 system was 93.02%,the yield of successful batches(excluding 3 failed batches of 0 yield)ranged from 31%to 91%,the average yield was 81.6%,and the RSD was 18.64%.The X-bar chart and R chart showed that most batches were within the control limit,and the overall production process was stable.However,the yield of some batches fluctuated due to abnormal vacuum pressure(such as 190 mbar vs.standard 600 mbar),excessively high hydrolysis temperature(93℃vs.standard 85-88℃),and operational deviations(improper installation of ferrule,failure to perform water bag inspection).The failed batches were mainly related to equipment vacuum faults(2 times)and operational errors(1 time).Conclusion The Fastlab 2 system has a good ability of automated synthesis,but the fluctuation of yield still needs attention.By optimizing the startup process confirmation of the equipment,improving the installation process of reagent card holders,strengthening the training of operators and standardizing the management of the experimental environment,the consistency of the system and the success rate of production can be effectively enhanced,providing a referenceable optimization path for similar radioactive drug production units.
作者
秦雪
QIN Xue(Department of Nuclear Medicine,Guizhou Provincial People’s Hospital,Guiyang Guizhou 550002,China)
出处
《中国医疗设备》
2025年第11期51-57,共7页
China Medical Devices
基金
2025年度贵州省基础研究计划(自然科学)基金(黔科合基础MS[2025]502)
2025年度贵州省卫生健康委科学技术基金(gzwkj2025-121)。
