Single-Point Process Sensing for Integrated Pharma Manufacturing Control
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Solution Overview
Problem
Continuous pharmaceutical and biopharmaceutical manufacturing processes face challenges in efficiently controlling integrated processes due to increased complexity and the need for rapid detection of discrepancies, which traditional off-line analytics cannot meet, and the use of multiple sensors increases costs and setup complexity.
Innovation Solution
A device assembly and method utilizing a single measuring unit to measure signals at a single location, providing corrective feedback for multiple process steps, allowing for real-time control of integrated continuous processes without the need for intermediate holding tanks or multiple sensors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple sensors are used to measure different parameters in integrated continuous processes, then measurement capability is improved, but device complexity and costs increase
Solution Approach 1:
The patent applies a single measuring unit capable of performing multiple measurement functions through different measurement modes. The measuring unit can operate in a first measurement mode to determine a first parameter and in a second measurement mode to determine a second parameter, eliminating the need for multiple separate sensors while maintaining comprehensive measurement capability across the integrated continuous process
Solution Approach 2:
The patent combines multiple measurement functions into a single integrated measuring unit. By merging the capabilities of what would traditionally require multiple separate sensors into one device, the system reduces setup complexity and device complexity while preserving the ability to measure multiple parameters (first parameter and second parameter) in the integrated continuous pharmaceutical or biopharmaceutical manufacturing process
2Device complexity
If traditional off-line analytics are used for process monitoring, then setup complexity is reduced, but response time and control efficiency deteriorate
Solution Approach 1:
The patent replaces traditional off-line analytics (manual sampling, sample preparation, measurement) with an automated on-line measurement system. The single measuring unit performs automated measurements directly in the process, eliminating the mechanical and manual steps of traditional off-line analytics. This substitution enables real-time detection of process parameters while maintaining simplicity in the overall control architecture
Solution Approach 2:
The measuring unit is designed to perform automated measurements and provide data to the control system without requiring manual intervention. The system serves itself by automatically determining process parameters and enabling feedback control, eliminating the need for manual sampling and sample preparation while achieving rapid response times for process monitoring and control
3Productivity
If integrated continuous processing is implemented to eliminate intermediate holding tanks, then productivity and facility footprint are improved, but process control complexity increases
Solution Approach 1:
The single measuring unit provides multi-functional measurement capability that addresses the control needs of integrated continuous processing. By being able to measure multiple parameters (first and second parameters) in different measurement modes, the system simplifies process control complexity while maintaining the productivity benefits of integrated continuous processing without intermediate holding tanks
Solution Approach 2:
The patent implements feedback control by using the measuring unit to determine process parameters and providing this information to the control system. The control system uses the determined values of the first and second parameters to adjust process conditions, creating a closed-loop feedback mechanism that manages the complexity of integrated continuous processing while maintaining high productivity
Data Source
AI summary
A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process including a first process equipment for performing a first process step; a second process equipment for performing a second process step subsequent to the first process step; a single measuring unit for measurement of a set of signals of a liquid process medium at a single location, the measured signals depending on first and second parameters; and an evaluation and control unit for evaluating the measured signals to determine values of the first and second parameters. The evaluation and control unit determines first and second corrective feedback based on the values of the first and second parameters, respectively. The evaluation and control unit controls the first process step by providing the first corrective feedback to the first process equipment and controls the second process step by providing the second corrective feedback to the second process equipment.