Batch-to-Batch Variation: A Key Component for Modeling Chemical Manufacturing Processes
Batch-to-Batch Variation: A Key Component for Modeling Chemical Manufacturing Processes
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批次间差异：化学制造过程建模的关键组成部分
DOI：
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
G. Reklaitis
中科院分区：
文献类型：
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作者：
L. Mockus;John J. Peterson;J. Laínez;G. Reklaitis
对于化学生产工艺，化学动力学文献几乎没有提到涉及批次间变化的定量模型。化学过程制造质量改进的模型正在被更仔细地考虑，特别是制药行业及其监管机构。最近ICH Q11关于原料药生产和质量的监管指南部分证明了这一点。质量改进被定义为减少目标的变化。因此，过程变异的建模在量化质量改进中起着重要的作用。由于批次间差异通常是过程差异的主要来源（通常超过测量误差差异），因此过程模型必须包含此类差异分量。在本文中，我们展示了化学动力学模型如何将批次间的变化以及测量误差。此外，我们表明，这些模型可以用来量化的Reli…
For chemical manufacturing processes, the chemical kinetics literature contains virtually no mention of quantitative models that involve batch-to-batch variation. Models for chemical process manufacturing quality improvement are being more carefully considered, particularly by the pharmaceutical industry and its regulators. This is evidenced in part by the recent ICH Q11 regulatory guidance on drug substance manufacture and quality. Quality improvement has been defined as a reduction in variation about a target. Hence the modeling of process variation plays an important role in quantifying quality improvement. Given that batch-to-batch variation is often a dominant source of process variation (usually exceeding measurement error variation), it is important for process models to incorporate such variance components. In this paper, we show how chemical kinetic models can incorporate batch-to-batch variation as well as measurement error. In addition, we show that these models can be used to quantify the reli...