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Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing
Allan S Myerson1, Markus Krumme2, Moheb Nasr3
1Massachusetts Institute of Technology, Cambridge, Massachusetts 02139.
Journal of Pharmaceutical Sciences
|August 1, 2017
Summary
Control systems engineering is crucial for continuous pharmaceutical manufacturing to ensure drug quality. Key challenges include process monitoring, integration, and risk analysis for robust production.
Area of Science:
- Pharmaceutical Manufacturing
- Control Systems Engineering
Background:
- Continuous manufacturing offers advantages over traditional batch processing for pharmaceuticals.
- Ensuring drug product quality requires advanced control systems engineering.
Purpose of the Study:
- To outline challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing.
- To facilitate the development and deployment of control systems technologies for drug quality assurance.
Main Methods:
- Discussion of current status and technical needs in process monitoring, control, systems integration, and risk analysis.
- Exploration of direct measurement, model-based predictions, and design space approaches for meeting critical quality attributes (CQAs).
Main Results:
- Continuous manufacturing success hinges on meeting CQAs, not just steady-state operation.
- Start-up/shutdown procedures, material traceability, and robust control systems are vital for economic and quality outcomes.
- Control systems must handle disturbances, dynamics, uncertainties, nonlinearities, and constraints.
Conclusions:
- Collaboration between universities, regulatory bodies, and industry is essential for advancing control systems engineering in pharmaceutical manufacturing.
- Development of funding mechanisms, training materials, and regulatory clarity are needed to overcome barriers.
- Focus on first-principles models, transportable technologies, and innovative process operations will drive progress.
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