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Improvement of a pharmaceutical powder mixing process in a tote blender via DEM simulations
| Contributor(s):: Benedict Benque, Luca Orefice, Thomas Forgber, Matthias Habeler, Beate Schmid, Johan Remmelgas, Johannes Khinast
An industrial-scale pharmaceutical powder blending process was studied via discrete element method (DEM) simulations. A DEM model of two active pharmaceutical ingredient (API) components and a combined excipient component was calibrated by matching the simulated response in a dynamic angle of...
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A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction
| Contributor(s):: Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson
Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...
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New gravimetric dosing device for Continuous Manufacturing
| Contributor(s):: VX management
"So far, it is mainly Loss in Weight feeders (LIW) that are used for this purpose, especially in the pharmaceutical industry, as they can handle smaller flow rates accurately enough. The mechanical concept of these is decades old and despite miniaturisation and improvements at detail...
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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
| Contributor(s):: Geng Tian
Continuous manufacturing (CM) of drug substances and drug productsProcess modeling and simulation (M&S) for CM at FDACM research highlightsOpportunities of CM for generic drug productsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing -...
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Modeling and simulation of continuous powder blending applied to a continuous direct compression process
| Contributor(s):: Galbraith, Shaun C., Liu, Huolong, Cha, Bumjoon, Park, Seo-Young, Huang, Zhuangrong, Yoon, Seongkyu
Continuous manufacturing techniques are increasingly being adopted in the pharmaceutical industry and powder blending is a key operation for solid-dosage tablets. A modeling methodology involving axial and radial tanks-in-series flowsheet models is developed to describe the residence time...
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A Systematic Framework for Process Control Design and Risk Analysis in Continuous Pharmaceutical Solid-Dosage Manufacturing
| Contributor(s):: Su, Qinglin, Moreno, Mariana, Giridhar, Arun, Reklaitis, Gintaras, Nagy, Zoltan
The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control...