Multivariate Process Chart Using Model-Based Sampling Limits

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Solution Overview

Problem

Existing methods for determining a multivariate process chart for producing chemical, pharmaceutical, biopharmaceutical, and biological products are costly, resource-intensive, and inefficient, particularly when using first-scale vessels, due to limited sampling frequency and the need for expensive scientific instruments, which complicates the determination of process parameters like viable cell density and nutrient concentration.

Innovation Solution

A computer-implemented method for creating a multivariate process chart using a first process control device that controls and periodically samples multiple first-scale vessels, defining groups of process parameter values, determining statistically representative values, and establishing trajectories with upper and lower limits, while minimizing resource use and sampling frequency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional methods are used to determine a multivariate process chart with frequent sampling and scientific instruments, then measurement precision and reliability are improved, but cost and resource consumption increase significantly

Engineering Contradiction:

Improveprocess parameter measurementVSAvoidmaterial cost

Core Design Contradiction:

Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent uses a computer-simulated process model that replicates the behavior of the actual chemical process, allowing virtual sampling and analysis instead of physical sampling. This digital twin approach provides accurate process parameter estimates without consuming physical materials or requiring expensive scientific instruments for every measurement.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent replaces physical sampling mechanisms and scientific instrumentation with a computational model-based estimation system. The computer-implemented process model calculates process parameters mathematically, substituting mechanical sampling and laboratory analysis with algorithmic computation, thereby eliminating material consumption while maintaining measurement capability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Manufacturing precision

If frequent sampling is performed to accurately determine process parameters, then manufacturing precision is improved, but productivity decreases due to time consumption

Engineering Contradiction:

Improveprocess control accuracyVSAvoidprocess determination speed

Core Design Contradiction:

Manufacturing precisionVSProductivity

Solution Approach 1:

The patent replaces time-consuming physical sampling and laboratory analysis with instant computational calculations. The computer-implemented model continuously estimates process parameters in real-time based on available data, eliminating the time delay inherent in physical sampling, transport, and analysis while maintaining high measurement accuracy.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent performs preliminary computational modeling and simulation to predict process parameter values before actual sampling occurs. By pre-calculating expected parameter ranges and using these predictions to guide minimal necessary sampling, the system achieves accurate process control with reduced sampling frequency, thereby improving productivity.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If multiple process parameters are measured simultaneously using scientific instruments, then reliability of process control is improved, but device complexity increases

Engineering Contradiction:

Improveprocess control reliabilityVSAvoidsampling and measurement system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent creates a universal computer-implemented process model that can estimate multiple different process parameters (concentrations, flow rates, temperatures, etc.) using a single integrated computational framework. This multi-functional software system replaces multiple specialized scientific instruments and sampling systems, reducing device complexity while maintaining the ability to measure all necessary parameters simultaneously.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent uses a virtual replication of the process system in computer software that mirrors the physical process behavior. This digital copy allows simultaneous monitoring and estimation of all process parameters through computation rather than through multiple physical sensors and instruments, thereby reducing the actual hardware complexity while maintaining comprehensive process control reliability.

Inventive Principle:

Principle #26Copying

Data Source

PatentUS12372928B2Multivariate process chart to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product

Publication Date: 2025.07.29 SARTORIUS STEDIM DATA ANALYTICS AB

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.