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

John Palmer, Christopher O'Malley, Matthew Wade, Elaine B. Martin, Trevor Page, Gary Montague

Research output: Contribution to journalArticleResearchpeer-review

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.
Original languageEnglish
Pages (from-to)1
Number of pages15
JournalJournal of Pharmaceutical Innovation
DOIs
Publication statusPublished - 26 Nov 2018

Fingerprint

Quality Control
Tablets
Population

Cite this

@article{358e0b598df24134ab1ecd1cf0f419f4,
title = "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 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.",
author = "John Palmer and Christopher O'Malley and Matthew Wade and Martin, {Elaine B.} and Trevor Page and Gary Montague",
year = "2018",
month = "11",
day = "26",
doi = "10.1007/s12247-018-9364-7",
language = "English",
pages = "1",
journal = "Journal of Pharmaceutical Innovation",
issn = "1872-5120",
publisher = "Springer New York",

}

Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line. / Palmer, John ; O'Malley, Christopher; Wade, Matthew ; Martin, Elaine B.; Page, Trevor; Montague, Gary.

In: Journal of Pharmaceutical Innovation, 26.11.2018, p. 1.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line

AU - Palmer, John

AU - O'Malley, Christopher

AU - Wade, Matthew

AU - Martin, Elaine B.

AU - Page, Trevor

AU - Montague, Gary

PY - 2018/11/26

Y1 - 2018/11/26

N2 - 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.

AB - 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.

U2 - 10.1007/s12247-018-9364-7

DO - 10.1007/s12247-018-9364-7

M3 - Article

SP - 1

JO - Journal of Pharmaceutical Innovation

JF - Journal of Pharmaceutical Innovation

SN - 1872-5120

ER -