Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line
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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.
KeywordsNear-infrared spectroscopy Tabletting Process analytical technology Quality control Pharmaceutics
The authors would like to acknowledge the significant contribution of GSK and GEA Pharma Systems to all aspects of the technical work described.
The authors would like to acknowledge the financial support of the UK Engineering and Physical Sciences Research Council grant EP/G037620/1 and the UK Technology Strategy Board
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