Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

Abstract

This paper investigates the application of on-line near infra-red 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 on-line 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.

Review of real-time release testing of pharmaceutical tablets: State-of-the art, challenges and future perspective

“…For continuous processes, the mixing homogeneity is assessed of a continuous stream of powder, which enables feedback process control as well as in-process control to divert material to waste. In the continuous case, it is more appropriate to integrate a PAT method in the transfer line between a blender and the tablet press (Järvinen et al, 2013;Palmer et al, 2018) or the feed frame of the tablet press (Hetrick et al, 2017), as discussed by Almaya et al (2017). If the point of testing is in the transfer line, then a sampling device that presents the sample (i.e.…”

Real‐time droplet size analysis using laser micrometer as a process analytical technology tool for continuous dripping process

“…Accurate on-line measurements of critical process parameters are vital for successful monitoring and process control. Therefore, PAT tools also play a crucial role in pharmaceutical manufacturing [8][9][10].…”