Development of a methodology to estimate error in the on-line measurements of blend uniformity in a continuous powder mixing process

A.U. Vanarase, M. Järvinen, Janne Paaso, F.J. Muzzio (Corresponding Author)

Research output: Contribution to journalArticleScientificpeer-review

33 Citations (Scopus)

Abstract

In this paper, a multi-point fiber optic based NIR system was implemented to monitor API concentration at the discharge of a continuous mixer. The sample size being interrogated by NIR was determined by measuring the velocity of the powder on the chute, which allowed selection of the number of scans to be averaged. A methodology was developed that allows quantification of the error associated with the in-line measurements. Comparison of in-line and off-line measurements was made at equivalent sample sizes. Mathematical model fitting for the in-line as well as off-line data revealed that the contribution of the analytical method error was negligible. A baseline RSD of 0.02 in the in-line measurements persists because of the inherent non-uniform nature of powder material. These results are useful towards achieving Real-Time-Release (RTR) of continuously manufactured drug product.
Original languageEnglish
Pages (from-to)263-271
Number of pages9
JournalPowder Technology
Volume241
DOIs
Publication statusPublished - 2013
MoE publication typeA1 Journal article-refereed

Keywords

  • continuous powder mixing
  • NIR (near infra-red)
  • spectroscopy
  • process analytical technology (PAT)

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