Palmer, J, O Malley, CJ, Wade, MJ et al. (3 more authors) (2020) Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line. Journal of Pharmaceutical Innovation, 15 (1). pp. 26-40. ISSN 1872-5120
Abstract
This paper investigates the application of online near-infrared measurements as a means to measure blend uniformity in a continuous tableting line. Underlying all the monitoring and control methods is the ability to measure key tablet properties online at a rate suitable for control purposes. The use of NIR to determine any deviations in blend uniformity is demonstrated by interpreting the relevant spectral signature allowing quantitative information to be acquired for process monitoring and quality assurance. In addition to demonstrating the functionality of the NIR probe, the practical issues arising in the application are discussed. The composition of the blend was measured using an NIR probe over a range of concentrations and the results were calculated comparing sub unit dose scale of scrutiny of small populations. This was compared with predicted product quality for whole tablets over the whole production period. This technique has demonstrated how data collected online can be used to successfully predict the quality of the whole production run for the purposes of real-time product quality assurance.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Springer Science+Business Media, LLC, part of Springer Nature 2018. This is an author produced version of a paper published in Journal of Pharmaceutical Innovation. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Near-infrared spectroscopy; Tabletting; Process analytical technology; Quality control; Pharmaceutics |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Engineering & Physical Sciences (Leeds) > School of Chemical & Process Engineering (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 18 Dec 2018 12:04 |
Last Modified: | 27 Mar 2020 16:07 |
Status: | Published |
Publisher: | Springer |
Identification Number: | 10.1007/s12247-018-9364-7 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:140033 |