Multivariate Process Chart for Low-Resource Bioprocess Control
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Solution Overview
Problem
Existing methods for determining a multivariate process chart for chemical, pharmaceutical, and biological product production are costly, time-consuming, and resource-intensive, particularly when using first-scale vessels, due to limitations in sampling frequency and the need for expensive scientific instruments, which are often not integrated into the process control device.
Innovation Solution
A computer-implemented method using a first process control device to control multiple first-scale vessels, where process parameters are periodically determined and grouped based on common characteristics, with statistically representative values establishing a trajectory, upper, and lower limits, enabling efficient determination of a multivariate process chart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional methods are used to determine a multivariate process chart with multiple process parameters, then measurement precision and reliability improve, but device complexity and cost increase significantly
Solution Approach 1:
The patent segments the process parameters into two categories: critical process parameters that require frequent monitoring and are integrated with the control device, and non-critical parameters that are monitored less frequently using separate scientific instruments. This segmentation reduces the complexity of integrating all instruments while maintaining measurement precision for critical parameters.
Solution Approach 2:
The control device is designed with multi-functionality, serving both as a process controller and as a monitoring system for critical parameters. This universal approach eliminates the need for separate dedicated measurement devices for all parameters, reducing overall device complexity while maintaining measurement capabilities.
2Productivity
If sampling frequency is increased to detect process deviations earlier, then productivity and reliability improve, but device complexity and resource consumption increase
Solution Approach 1:
The patent implements periodic sampling with varying frequencies based on process stage and parameter criticality. Critical parameters are sampled more frequently during critical process stages, while non-critical parameters are sampled less frequently. This periodic action with adaptive frequency achieves early deviation detection without requiring continuous high-frequency sampling of all parameters, thus reducing time loss and resource consumption.
3Reliability
If all process parameters are monitored continuously with high frequency, then measurement precision and reliability improve, but loss of substance and resource consumption increase
Solution Approach 1:
The patent applies local quality by differentiating monitoring intensity based on process location and parameter importance. Critical parameters at critical process stages are monitored with high frequency and precision, while non-critical parameters are monitored with lower frequency. This localized approach to quality monitoring maintains reliability where needed while reducing overall sample material consumption.
Data Source
AI summary
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.