应用六西格玛工具改善冻干粉针剂生产过程炸瓶率

Application of six sigma tools to improve the bottle-frying rate of freeze-dried powder injection in the production process

目的:改善冻干粉针剂生产过程中易出现管制瓶炸瓶现象。方法:应用六西格玛工具对炸瓶产生的原因进行界定、对相关生产工序的关键设备如隧道烘箱、灌装机等设备炸瓶现象统计分析频次,根据分析的情况采取相应改进措施以减少炸瓶情况发生。结果:改进措施实施后,炸瓶检出率由4.14×10-6下降为0.99×10-6,效果显著。结论:六西格玛是基于事实和数据的管理工具,用于改善冻干粉针剂生产过程炸瓶现象非常有效,值得推广。

Objective: To improve the phenomena of bottle explosion in the production of freeze-dried powder injection. Methods: Six sigma tools were used to define the causes of bottle explosion, to analyze the frequency of bottle explosion of key equipment such as tunnel oven and filling machine, and to take corresponding improvement measures to reduce the occurrence of bottle explosion. Results: The detection rate of explosive bottles decreased from 4.14×10-6 to 0.99×10-6 after the implementation of the improvement measures, and the effect was remarkable. Conclusion: Six Sigma is a management tool based on facts and data. It is very effective to improve the phenomenon of bottle explosion in the production of freeze-dried powder injection and worth promoting.