Sayin, R., Martinez-Marcos, L., Osorio, J.G. et al. (5 more authors) (2015) Investigation of an 11 mm diameter twin screw granulator: Screw element performance and in-line monitoring via image analysis. International Journal of Pharmaceutics, 496 (1). pp. 24-32. ISSN 0378-5173
Abstract
As twin screw granulation (TSG) provides one with many screw element options, characterization of each screw element is crucial in optimizing the screw configuration in order to obtain desired granule attributes. In this study, the performance of two different screw elements - distributive feed screws and kneading elements - was studied in an 11 mm TSG at different liquid-to-solid (L/S) ratios. The kneading element configuration was found to break large granules more efficiently, leading to narrower granule size distributions. While pharmaceutical industry shifts toward continuous manufacturing, inline monitoring and process control are gaining importance. Granules from an 11 mm TSG were analysed using the Eyecon™, a real-time high speed direct imaging system, which has been used to capture accurate particle size distribution and particle count. The size parameters and particle count were then assessed in terms of their ability to be a suitable control measure using the Shewhart control charts. d10 and particle count were found to be good indicators of the change in L/S ratio. However, d50 and d90 did not reflect the change, due to their inherent variability even when the process is at steady state.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 Elsevier B.V. This is an author produced version of a paper subsequently published in International Journal of Pharmaceutics. Uploaded in accordance with the publisher's self-archiving policy. Article available under the terms of the CC-BY-NC-ND licence (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
Keywords: | Twin screw granulation; In-line image analysis; Shewhart control charts; Continuous pharmaceutical manufacturing; Process analytical technology |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Engineering (Sheffield) > Department of Chemical and Biological Engineering (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 16 Aug 2016 09:53 |
Last Modified: | 18 Nov 2016 17:11 |
Published Version: | http://dx.doi.org/10.1016/j.ijpharm.2015.09.024 |
Status: | Published |
Publisher: | Elsevier |
Refereed: | Yes |
Identification Number: | 10.1016/j.ijpharm.2015.09.024 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:102551 |