无菌药品生产环境悬浮粒子的不确定度评定

摘要

目的：分析影响无菌药品生产工艺环境中悬浮粒子不确定度的来源,提高检测结果的准确性。方法分析影响因素,建立数学模型,评价测量过程中各不确定度分量。结果取转=2(95%置信概率)时,扩展不确定度为U(M0.05)=5364粒/m3,U(M5)=88粒/m3。结论对无菌药品生产工艺环境的悬浮粒子数的不确定度主要是由仪器的测量性能和采样点的分布及测量引入的。%Objective To analyse the impact source of uncertainty of the suspended particle in aseptic processing envi-ronments of sterile products,to improve the accuracy of the testing results. Methods The impact factor was analyzed and the uncertainty components were assessed through a mathematical model in measurement process. Results Taking K=2(95% confidence level),the results of expended uncertainty was 5364 particles/m3(≥0.5 μm airborne particles) and 88 particles/m3 (≥5 μm airborne particles). Conclusions The uncertainty is mainly induced by the function of instru-ments and the measuring points of different samples.