首页> 外国专利> MULTIVARIATE PROCESS CHART TO CONTROL A PROCESS TO PRODUCE A CHEMICAL, PHARMACEUTICAL, BIOPHARMACEUTICAL AND/OR BIOLOGICAL PRODUCT

MULTIVARIATE PROCESS CHART TO CONTROL A PROCESS TO PRODUCE A CHEMICAL, PHARMACEUTICAL, BIOPHARMACEUTICAL AND/OR BIOLOGICAL PRODUCT

机译:用于控制生产化学,制药,生物制药和/或生物产品的过程的多元过程图

摘要

Aspects of the application related to methods, a computer program and a process control device. According to one aspect, a computer-implemented method for determining a multivariate process chart is provided. The multivariate process chart is to be used to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product. The multivariate process chart includes a first trajectory, an upper limit for the first trajectory and a lower limit for the first trajectory. The method comprises providing a plurality of first-scale vessels, each of the first-scale vessels containing fluid for producing the product. The method further comprises receiving, by a first process control device, process parameters, the process parameters including process parameters to be controlled and process parameters to be measured. The method further comprises controlling, by the first process control device and at least partly in parallel, the process in each of the first-scale vessels. The method further comprises periodically determining, at least in part by the first process control device, process parameter values for the process parameters from the fluid in each of the first-scale vessels. The method further comprises defining groups of the process parameter values according to a common characteristic, wherein each of the groups includes process parameter values determined from multiple ones of the first-scale vessels. The method further comprises determining at least one statistically representative value for each of the groups of process parameter values. The method further comprises establishing the first trajectory from the statistically representative values. The method further comprises determining the upper limit and the lower limit based on a measure of variation within each group.
机译:本申请的方面涉及方法,计算机程序和过程控制设备。根据一个方面,提供了一种用于确定多元过程图的计算机实现的方法。多元过程图将用于控制生产化学,药物,生物制药和/或生物产品的过程。多元过程图包括第一轨迹,第一轨迹的上限和第一轨迹的下限。该方法包括提供多个第一规模的容器,每个第一规模的容器包含用于生产产品的流体。该方法还包括由第一过程控制装置接收过程参数,该过程参数包括要控制的过程参数和要测量的过程参数。该方法还包括通过第一过程控制装置并且至少部分地并行控制每个第一规模容器中的过程。该方法还包括至少部分地由第一过程控制装置周期性地从每个第一规模容器中的流体确定用于过程参数的过程参数值。该方法还包括根据共同特征定义过程参数值的组,其中,每个组包括从多个第一尺度容器确定的过程参数值。该方法还包括为过程参数值的组中的每一个确定至少一个统计上代表性的值。该方法还包括从统计上代表性的值建立第一轨迹。该方法还包括基于每个组内的变化的量度来确定上限和下限。

著录项

  • 公开/公告号EP3702439A1

    专利类型

  • 公开/公告日2020-09-02

    原文格式PDF

  • 申请/专利权人 SARTORIUS STEDIM DATA ANALYTICS AB;

    申请/专利号EP20190159403

  • 发明设计人 HOEHSE MAREK;GRIMM CHRISTIAN;

    申请日2019-02-26

  • 分类号C12M1/36;G05B19/418;G05B23/02;

  • 国家 EP

  • 入库时间 2022-08-21 11:39:16

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