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Combining microwave resonance technology to multivariate data analysis as a novel PAT tool to improve process understanding in fluid bed granulation

A set of 192 fluid bed granulation batches at industrial scale were in-line monitored using microwave resonance technology (MRT) to determine moisture, temperature and density of the granules. Multivariate data analysis techniques such as multiway partial least squares (PLS), multiway principal comp...

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Bibliographic Details
Main Authors: Lourenço, Vera (Author) , Herdling, Thorsten (Author) , Reich, Gabriele (Author) , Menezes, José C. (Author) , Lochmann, Dirk (Author)
Format: Article (Journal)
Language:English
Published: 2011
In: European journal of pharmaceutics and biopharmaceutics
Year: 2011, Volume: 78, Issue: 3, Pages: 513-521
ISSN:1873-3441
DOI:10.1016/j.ejpb.2011.02.008
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejpb.2011.02.008
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0939641111000592
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Author Notes:Vera Lourenço, Thorsten Herdling, Gabriele Reich, José C. Menezes, Dirk Lochmann
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Summary:A set of 192 fluid bed granulation batches at industrial scale were in-line monitored using microwave resonance technology (MRT) to determine moisture, temperature and density of the granules. Multivariate data analysis techniques such as multiway partial least squares (PLS), multiway principal component analysis (PCA) and multivariate batch control charts were applied onto collected batch data sets. The combination of all these techniques, along with off-line particle size measurements, led to significantly increased process understanding. A seasonality effect could be put into evidence that impacted further processing through its influence on the final granule size. Moreover, it was demonstrated by means of a PLS that a relation between the particle size and the MRT measurements can be quantitatively defined, highlighting a potential ability of the MRT sensor to predict information about the final granule size. This study has contributed to improve a fluid bed granulation process, and the process knowledge obtained shows that the product quality can be built in process design, following Quality by Design (QbD) and Process Analytical Technology (PAT) principles.
Item Description:Gesehen am 09.11.2022
Physical Description:Online Resource
ISSN:1873-3441
DOI:10.1016/j.ejpb.2011.02.008

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