洁净室中沉降菌测量不确定度评定
目的 计算洁净室中沉降菌测量的不确定度。方法 建立数学模型, 评估和量化沉降菌测定过程中可能产生影响的各个不确定度分量, 分别计算A、B类各不确定度分量值、合成标准不确定度、扩展不确定度。结果 沉降菌的菌落数为4个/皿时, 其合成标准不确定度为0.861个/皿, 取包含因子k=2(置信概率为95%), 沉降菌的扩展不确定度为U=uc×k =0.861×2≈2个/皿; 洁净区沉降菌结果为 (4±2)个/皿, k=2。结论 对于洁净室沉降菌的不确定度评定, 其中A类不确定度这一分量占比最大, B类不确定度各个分量值均很小, 所以进行沉降菌的不确定度评定时主要是以A类不确定度为主, B类不确定度所带来的影响可以忽略不计。
Objective To evaluate the uncertainty of measurement of settling microbe in clean room. Methods The mathematical model was established to evaluate and quantify the various uncertainty components that might affect the sedimentation process, and the uncertainty component values of A and B, the synthetic standard uncertainty, and the extended uncertainty were calculated. Results When the colony number of settling microbe was 4/plate, the standard uncertainty of synthesis was 0.861/plate. Taking the inclusion factor k=2 (95% confidence level), the extended uncertainty of settling microbe was U=uc×k =0.861×2≈2 /plate, and the result of settling microbe in the clean area was (4±2)/plate, k=2. Conclusion For the uncertainty assessment of clean room settling bacteria, the component of class A uncertainty accounts for the largest proportion, and the component of class B uncertainty is small. Therefore, the uncertainty of the settlement bacteria is mainly based on the class A uncertainty, and the impact of the class B uncertainty is negligible.
标题:洁净室中沉降菌测量不确定度评定
英文标题:Uncertainty evaluation for measurement of settling microbe in clean room
作者:
李诗华 汤臣倍健股份有限公司
李建新 汤臣倍健股份有限公司
刘长富 汤臣倍健股份有限公司
蔡伟江 汤臣倍健股份有限公司
中文关键词:沉降菌,测量不确定度,洁净室,
英文关键词:settling microbe,measurement uncertainty,clean room,
发表日期:2019-08-23
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