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Sensitivity analysis of a pharmaceutical tablet production process from the control engineering perspective.
Jakob Rehrl1, Arlin Gruber2, Johannes G Khinast3
1Institute of Automation and Control, Graz University of Technology, Inffeldgasse 21/B/I, 8010 Graz, Austria; Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
This study applies sensitivity analysis to pharmaceutical direct compaction, revealing how process variables impact outcomes. Understanding these relationships is key for effective process control and optimization in drug manufacturing.
Area of Science:
- Pharmaceutical manufacturing
- Chemical engineering
- Process control
Background:
- Direct compaction is a key pharmaceutical manufacturing process.
- Process insights are crucial for effective control strategies.
- Sensitivity analysis offers a systematic approach to understanding process dynamics.
Purpose of the Study:
- To perform a sensitivity analysis on a pharmaceutical direct compaction process.
- To establish mathematical models for individual unit operations.
- To explore methods for assigning actuating signals to controlled variables.
Main Methods:
- Development of mathematical models for unit operations.
- Application of sensitivity analysis using Sobol indices.
- Utilizing steady-state gains and frequency response for analysis.
Main Results:
- Quantification of the impact of various input parameters on the direct compaction process.
- Identification of critical process variables and their influence.
- Systematic assignment of actuating signals to controlled variables.
Conclusions:
- Sensitivity analysis provides valuable insights into pharmaceutical direct compaction.
- Mathematical modeling and defined analysis methods enable robust process understanding.
- This approach facilitates the design of effective process control concepts.
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