应用六西格玛统计技术对A型肉毒毒素中间品量器的分析

目的应用六西格玛(6σ)统计技术对A型肉毒毒素中间品取用时所用的量出式量器进行分析研究。方法以偏倚-线性做考察指标研究对比分度吸管及移液器的准确度,对吸管进行变异源分析(单因素、双因素交叉及嵌套设计分析)。结果分度吸管未发生偏倚,较移液器具有更好的准确度;人员、操作批次对吸管量取效果无显著影响,吸管间的差异是主要影响因素。结论通过对测量得出的结果进行分析,确定吸管和三通吸球为最佳量器组合,同时吸管间的差异是影响其的主要因素。

Application of six sigma statistical technology in analysis of measuring container for intermediate product of botulinum toxin type A

【Objective】To analyze and study the measuring instrument used in the intermediate product of botulinum toxin A using six sigma statistical technology.【Methods】The accuracy of graduated pipette and quantitative adjustable pipet was compared by using bias-linearity as inspection index,as well as analyze the variation source of graduated pipette by using single factor,two factor crossover and nested design analysis.【Results】There was no bias in the graduated pipette,which had better accuracy than the quantitative adjustable pipet.There was no significant effect on the graduated pipette by personnel and operation batch,and the difference between graduated pipettes was the main influencing factor.【Conclusion】Through the analysis of the measurement results,it is determined that the best measuring container combination is the graduated pipette and the Pipet Filler,and the difference between the graduated pipettes is the main influencing factor.