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1、关键工艺参数的定义指南 ( 中英比照) ( 总 4 页)本页仅作为文档封面，使用时可以删除This document is for reference only-rar21year.MarchGuidance in defining critical process parameters关键参数的定义指南The criticality of a process parameter is an assessment of the probability that it can be consistently and reproducibly controlled within the prove
2、n acceptable range (PAR) during routine manufacturing.工艺参数的关键性是指在生产中对可承受范围的持续重复掌握的可能性的评估，This probability depends on可能性主要取决于： the robustness of the process parameter (the width of the PAR)工艺参数的稳定性可承受范围的宽度 the ability to technically control the parameter (technical limitations)参数掌握的技术力量技术限制 the uncer
3、tainty of the measurement of the parameter (reflected by the standard参数测量的不确定性用标准偏差来反映deviation )The robustness of a process parameter is reflected by the width of the proven acceptable range. The widerthe range within which a parameter could be varied during process qualification without impacting
4、product quality, the more robust it is.可承受的参数范围反映工艺参数的稳定性。在参数确认中不影响产品质量的可转变的参数的范围越宽，工艺越稳定。The ability to technically control a parameter is a function of a combination of process properties and equipment capabilities. For example, a highly exothermic reaction might be well controlled in a small stai
5、nless steel vessel, but could prove impossible to control in a larger glass-lined vessel.参数的技术掌握力量是工艺特性和设备力量的综合功能。例如，一个高放热的反响可能在一个小的不锈钢反响釜内能够很好的被掌握，但是在一个大的塘玻璃反响釜内证明是不行能掌握的。The uncertainty of a measurement () is the combined uncertainty of the calibration of the probe, thevariance of the probe itself
6、, and the variance of the signal transmission from the probe to the distributed control system (DCS). If the measurement is normally distributed, 3.4 out of a million data points will be outside a range of +/- 4.5 standard deviations. This is the basis of the six sigma theory. The difference of1.5 b
7、etween 4.5 and 6 is an empirical value chosen based on the observation that the mean of real processes tends to drift by this value over time. Based on the 6-concept we define a parameter as critical when the proven acceptable range is narrower than six standard deviations.测量的不确定性是探头或检测器的校验，监测器本身的变化
8、和从探头到 DCS 的信号传输的变化的不确定因素的综合。假设测量结果是正态分布的，3.4PPM百万分之一将在+/-4.5 标准偏差的范围之外。这是六西格玛理论的根底。4.5 和 6 之间 1.5 的差异是一个阅历值基于观看实际工艺趋势相对时间数值的漂移。基于六西格玛概念当一个参数的可承受的范围比+/-六个标准偏差窄时， 我们定义这个参数为关键参数。2figure 1: critical parameterset pointfigure 2: non-critical parameterset point4 04 55 05 56 06 57 04 04 55 05 56 06 57 06 6
9、6 6 proven acceptable rangelower/upper edge of failureproven acceptable rangelower/upper edge of failure3Whereas a proven acceptable range depends only on the process, the variance of a control system is equipment-specific. The variance of a control system for the same process parameter might be dif
10、ferent in another operational environment, which could result in a different criticality assessment (e.g. a critical3process parameter in one plant may be judged to be non-critical in another plant which has a control system with a lower variance).假设一个可承受的参数范围仅仅依靠于工艺，掌握系统的变异是设备属性。对同样的工艺参数的掌握系统的变异可能在
11、另一个操作环境下不同，这个可能导致一个不同的关键性评估比方在一个工厂的一个关键参数在另一个有较低变异的掌握系统的工厂就可能被判定为不关键The following table can be used for guidance to assess the criticality of a process parameter以以下表在指南中用于评定一个工艺参数的关键性minimumPARfortype of process parameter工艺参数的类型assumption for non-critical parameterComment( 6)判定不关键的最小 备注可承受范围Temperat
12、ure0.6%温度+/-4%range)For the typical measurement (ofmeasurementrange of -20 to 180C: +/-8CAmount (quantity) by weight重量Amount (quantity) by volume体积数量pHPressure (vacuum)0.8%2%0.1 pH-unit(检测范围的)+/-5% (of set point)设定点的+/-12% (of set point)设定点的+/-0.6pH-units+/-1.0 pH-units 1)对 于 典 型 的 测 量 范 围 -20180C，范
13、围为+/-8CThe limits of the balance have to be taken into account. See:称的限度应当带进数量Important: a certain minimal flow has to be exceeded重要提示：必需超过确定的最小流量The pH is typically more difficult to control than to measure.pH 是典型的掌握难于检测Pressure is typically more difficult to control than to压力真空0.8%+/- 20% 2)measur
14、e.压力是典型的掌握难于检测1) The pH is typically much more difficult to be controlled than to be measured. Unless a system is in place which significantly reduces the control uncertainties (local pH, re-adjustment, etc.) a PAR of +/-1.0 pH units is recommended.pH 是典型的掌握比检测要难得多。假设一个适当的系统能够显著的降低掌握的不确定性在线pH，重校正等推举使用+/-1.0pH 的可承受的范围。2) Taking into account the difficulties of controlling a pressure under changing process conditions as obs
