疫苗生产洁净室中悬浮粒子检测的不确定度评估

Uncertainty degree evaluation of suspended particle test in vaccine production clean room

目的评估疫苗生产洁净室中悬浮粒子检测结果的不确定度。方法分析影响悬浮粒子检测结果不确定度的因素,建立数学模型,逐项评价并量化各项的相对标准不确定度,计算合成标准不确定度,最终得出测量结果的扩展不确定度并给出测量结果不确定度报告。结果取k=2(置信概率95%)时,粒径≥0.5μm悬浮粒子测量结果的扩展不确定度为672粒/m3,悬浮粒子数为(1781±672)粒/m3;粒径≥5μm悬浮粒子测量结果的扩展不确定度为138粒/m3,悬浮粒子数为(270±138)粒/m3。结论此评价方法适用于洁净室中悬浮粒子测量结果的不确定度评估。

Objective To evaluate the uncertainty degree of suspended particle test in vaccine production clean room.Methods Uncertainty factors that impacted the suspended particle test results were analyzed,mathematical model was established to evaluate and quantificat the related standard uncertainty of each term by term.Synthetic criterion uncertainty was counted and then expanded uncertainty of determination results was got and the report of determination results uncertainty was provided. Results When k was equal to 2（the confidence probability was 95%）,the expanded uncertainty of particle size greater than or equal to 0.5 μm suspended particle test results was 672/m3 and the number of suspended particle was（1781 ±672）/m3.The expanded uncertainty of particle size greater than or equal to 5 μm suspended particle test results was 672/m3 and the number of suspended particle was（270±138）/m3. Conclusion This evaluation method is suitable for uncertainty evaluate of suspended particle test results in clean room.