Multivariate process chart to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product
AssigneeSartorius Stedim Data Analytics AB
InventorsMarek Hoehse, Christian Grimm
Life of this patent
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Abstract
Aspects of the application relate 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.
Claims18
A computer-implemented method for determining a multivariate process chart, the multivariate process chart to be used to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product, the multivariate process chart including a first trajectory, an upper limit for the first trajectory and a lower limit for the first trajectory, the method comprising:
- providing a plurality of first-scale vessels, each of the first-scale vessels containing fluid for producing the product;
- receiving, by a first process control device, process parameters, the process parameters including process parameters to be controlled and process parameters to be measured;
- controlling, by the first process control device and at least partly in parallel, the process in each of the first-scale vessels;
- and
- 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;
- 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;
- determining at least one statistically representative value for each of the groups of process parameter values;
- establishing the first trajectory from the statistically representative values;
- and
- determining the upper limit and the lower limit based on a measure of variation within each group.
A process control device for determining a multivariate process chart, the multivariate process chart to be used to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product, the multivariate process chart including a first trajectory, an upper limit for the first trajectory and a lower limit for the first trajectory, the device comprising:
- a plurality of first-scale vessels, each of the first-scale vessels being configured to contain fluid for producing the product;
- a robot capable of addressing each first-scale vessel, dispensing fluid to the first-scale vessels, and extracting samples of fluid from the first-scale vessels;
- and
- a controller operable to:
- receive process parameters, the process parameters including process parameters to be controlled and process parameters to be measured;
- control, at least partly in parallel, the process in each of the first-scale vessels;
- cause process parameter values to be periodically determined for process parameters from the fluid in each of the first-scale vessels;
- define 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;
- determine at least one statistically representative value for each of the groups of process parameter values;
- establish the first trajectory from the statistically representative values;
- determine the upper limit and the lower limit based on a measure of variation within each group.
Dependencies are inferred from the claim text.