Powder dosing within continuous manufacturing: A lean approach for gravimetric dosing configuration and equipment selection

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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Publication Details

Journal
International Journal of Pharmaceutics
Published
2024-11-08
DOI
https://doi.org/10.1016/j.ijpharm.2024.124903
Citations
2
Primary Topic
Manufacturing Process and Optimization
Type
article
Field-Weighted Citation Impact
0.70

Funders

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article

Powder dosing within continuous manufacturing: A lean approach for gravimetric dosing configuration and equipment selection

Karl Wagner, Martin Maus, Sébastien Paul, P. Schneider
2 citations
International Journal of Pharmaceutics
Manufacturing Process and Optimization
0.70
article

Powder dosing within continuous manufacturing: A lean approach for gravimetric dosing configuration and equipment selection

Karl Wagner, Martin Maus, Sébastien Paul, P. Schneider
article en
2 citations

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.

International Journal of PharmaceuticsVol. 667(Pt B)
Boehringer Ingelheim (Germany) (DE), University of Bonn (DE), Boehringer Ingelheim (Japan) (JP)
Boehringer Ingelheim
Openalex Percentile: Top 25%
Manufacturing Process and Optimization
0.70
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