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Published on: August 18, 2023
Powder dosing within continuous manufacturing: A lean approach for gravimetric dosing configuration and equipment
Petra Schneider1, Martin Maus2, Shubhajit Paul3
1Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.
Abstract:
This work presents a novel approach to select gravimetric dosing configurations for continuous unit operations in pharmaceutical processing. It optimizes material, time, and personnel use, and allows selections for configurations of materials not included in the model by robust material attribute-based interpolation. The approach does not apply Principal Component Analysis (PCA) and Partial Least Squares (PLS). Instead, a reduced set of material attributes that require measurement was determined from existing material attribute libraries found in literature. Only those identified 17 attributes were measured for 13 materials and employed in this study. The established model proved to be predictive for an even further reduced attribute set of 12 attributes. The model introduces a simplified method for selecting feeding equipment combining precision metrics (relative mean intra-bin variability) and model parameters (fmax, fmin, β). The reduction of Material Attributes (MAs) in this short-cut method enables fast evaluation and enhances resource efficiency by incorporating only a few selected MAs into the model and therefore introduces a different line of thinking. It was also possible to compare feeding of different hopper geometries, showing that flat bottom-hoppers have higher dosing precision than round bottom-hoppers. In conclusion, this work introduces a smart and innovative model that simplifies the equipment selection process and brings objectivity through a comprehensive numerical description of the discharge characteristics, and provides new options for continuous dosing in pharma through combining precision and curve fitting parameters.
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