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Model driven design for integrated twin screw granulator and fluid bed dryer via flowsheet modelling
Li Ge Wang1, Chalak Omar2, James Litster2
1Siemens Process Systems Engineering, Hammersmith, London, UK; Department of Chemical and Biological Engineering, University of Sheffield, UK.
International Journal of Pharmaceutics
|September 21, 2022
Summary
This study models integrated twin screw granulation and fluid bed drying using Model Driven Design. This approach optimizes product quality by exploring process physics for efficient design space analysis.
Area of Science:
- Chemical Engineering
- Pharmaceutical Technology
- Process Systems Engineering
Background:
- Integrated pharmaceutical manufacturing processes require robust modeling for quality control.
- Model Driven Design (MDD) offers a physics-based approach to optimize complex processes.
- Understanding Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) is crucial for process validation.
Purpose of the Study:
- To develop and validate a flowsheet model for an integrated twin screw granulation (TSG) and fluid bed dryer (FBD) process.
- To utilize the Model Driven Design (MDD) approach for efficient process design space exploration.
- To assess the impact of Critical Process Parameters (CPPs) on Critical Quality Attributes (CQAs) through Global System Analysis (GSA).
Main Methods:
- Implementing a Model Driven Design (MDD) framework for integrated TSG and FBD processes.
- Developing mechanistic-based process models for both granulation and drying stages.
- Conducting targeted experiments for model calibration and validation, focusing on kinetic parameters.
- Utilizing Global System Analysis (GSA) to evaluate parameter uncertainty and its effect on product quality.
Main Results:
- Successful development of a calibrated and validated flowsheet model for the integrated TSG-FBD process.
- Identification of liquid to solid ratio (L/S) in TSG and inlet air temperature in FBD as key Critical Process Parameters (CPPs).
- Quantification of the uncertainty in Critical Quality Attributes (CQAs) stemming from variations in CPPs.
Conclusions:
- Model Driven Design (MDD) provides a powerful, physics-driven alternative to extensive experimental trials for process optimization.
- The validated model enables effective exploration of the design space for integrated granulation and drying processes.
- Understanding CPP-CQA relationships is essential for ensuring consistent product quality in pharmaceutical manufacturing.
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