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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.
This study introduces a novel method for selecting gravimetric dosing equipment in pharmaceutical manufacturing. It simplifies selection by using fewer material attributes, optimizing resource use and improving dosing precision.
Area of Science:
- Pharmaceutical Engineering
- Process Chemistry
- Materials Science
Background:
- Selecting gravimetric dosing configurations for continuous pharmaceutical processing is complex.
- Existing methods may not be resource-efficient or adaptable to new materials.
Purpose of the Study:
- To develop a simplified, robust approach for selecting gravimetric dosing equipment configurations.
- To optimize material, time, and personnel usage in pharmaceutical continuous manufacturing.
Main Methods:
- Determined a reduced set of 17 material attributes from literature.
- Measured these attributes for 13 materials.
- Developed a predictive model using a subset of 12 material attributes and incorporating precision metrics (relative mean intra-bin variability) and model parameters (fmax, fmin, β).
Main Results:
- The model accurately predicts dosing configurations using a reduced set of material attributes.
- A simplified method for equipment selection was established, enhancing resource efficiency.
- Flat bottom-hoppers demonstrated higher dosing precision compared to round bottom-hoppers.
Conclusions:
- The novel model simplifies pharmaceutical equipment selection for continuous dosing.
- It introduces objectivity through numerical discharge characteristics and enhances resource efficiency.
- The approach offers new possibilities for continuous dosing by combining precision and curve fitting parameters.
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