Single-Point Process Analytics for Continuous Pharma Control
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Solution Overview
Problem
Continuous pharmaceutical and biopharmaceutical manufacturing processes are complex and prone to process deviations due to the need for rapid control of integrated steps, which traditional off-line analytics cannot efficiently manage, and the use of multiple sensors increases costs and 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 manufacturing processes by evaluating signals related to multiple parameters using chemometric models.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple sensors are used to measure different parameters at different locations, then measurement precision and process control capability are improved, but device complexity and costs increase
Solution Approach 1:
A single measuring unit is designed to perform multiple measurement functions by sequentially measuring different optical properties (absorbance, fluorescence, scattering) of the process medium. This multi-functional approach allows one device to replace multiple specialized sensors, reducing system complexity while maintaining comprehensive process monitoring capability across different process steps.
2Device complexity
If traditional off-line analytics are used for process monitoring, then device complexity is reduced, but productivity and response time deteriorate due to labor-intensive manual sampling and slow analysis
Solution Approach 1:
Manual mechanical sampling and off-line analysis operations are replaced by an automated in-line measuring unit that continuously monitors process parameters. The system automatically draws process medium, performs optical measurements, and provides real-time feedback without manual intervention, thereby increasing productivity and response time while maintaining relatively simple device architecture.
Solution Approach 2:
The measuring unit is integrated with a control system that provides real-time feedback based on measured parameters. This closed-loop feedback enables automatic process adjustments without manual analysis, significantly improving productivity and response time compared to traditional off-line analytics while keeping the overall system manageable through automated control algorithms.
3Productivity
If integrated continuous processing is implemented to eliminate intermediate holding tanks, then productivity and facility footprint are improved, but the risk of process deviations increases due to faster processing speeds
Solution Approach 1:
Real-time in-line measurement and automated feedback control are implemented to continuously monitor critical process parameters during integrated continuous processing. This enables immediate detection and correction of process deviations, maintaining high reliability despite the faster processing speeds and elimination of intermediate holding tanks that characterize integrated continuous manufacturing.
4Device complexity
If a single measuring unit is used to control multiple process steps, then device complexity and costs are reduced, but measurement precision for multiple parameters may deteriorate
Solution Approach 1:
The measurement process is segmented into sequential measurements of different optical properties (absorbance, fluorescence, scattering) at the same location. By dividing the measurement task into distinct sequential steps rather than attempting simultaneous multi-parameter measurement, the system maintains high precision for each parameter while using a single measuring unit, thus avoiding the need for multiple specialized sensors.
Data Source
Figure 1
AI summary
A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process comprises: a first process equipment (10) adapted for performing a first process step; a second process equipment (20) adapted for performing a second process step subsequent to the first process step; a single measuring unit (24) adapted for measurement of at least one set of signals of a liquid process medium at a single location, the set of measured signals depending on at least a first parameter and a different second parameter; and an evaluation and control unit (28) adapted for evaluating the set of measured signals to determine a value of the first parameter and a value of the second parameter. The evaluation and control unit (28) is further adapted for determining a first corrective feedback based on the value of the first parameter and a different second corrective feedback based on the value of the second parameter. The evaluation and control unit (28) is further adapted for controlling the first process step by providing the first corrective feedback to the first process equipment (10) and for controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (20).