Process Monitoring of Moisture Content and Mass Transfer Rate in a Fluidised Bed with a Low Cost Inline MEMS NIR Sensor

Authors

Claudio R Avila
Joan Ferré
Rodrigo Rocha de Oliveira
Anna de Juan
Wayne E Sinclair
Faiz M Mahdi
Ali Hassanpour
Timothy N Hunter
Richard A Bourne
Frans L Muller

Publication Date

4-21-2020

Journal

Pharmaceutical Research

DOI

10.1007/s11095-020-02787-y

PMID

32318827

PMCID

PMC7174278

PubMedCentral® Posted Date

4-21-2020

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Drug Compounding, Micro-Electrical-Mechanical Systems, Powders, Pressure, Spectroscopy, Near-Infrared, Technology, Pharmaceutical, Temperature, Water, fluidised bed drying, mass transfer resistance, MEMS Fabry-Pérot interferometer sensor, near infrared spectroscopy, online process monitoring

Abstract

PURPOSE: The current trend for continuous drug product manufacturing requires new, affordable process analytical techniques (PAT) to ensure control of processing. This work evaluates whether property models based on spectral data from recent Fabry-Pérot Interferometer based NIR sensors can generate a high-resolution moisture signal suitable for process control.

METHODS: Spectral data and offline moisture content were recorded for 14 fluid bed dryer batches of pharmaceutical granules. A PLS moisture model was constructed resulting in a high resolution moisture signal, used to demonstrate (i) endpoint determination and (ii) evaluation of mass transfer performance.

RESULTS: The sensors appear robust with respect to vibration and ambient temperature changes, and the accuracy of water content predictions (±13 % ) is similar to those reported for high specification NIR sensors. Fusion of temperature and moisture content signal allowed monitoring of water transport rates in the fluidised bed and highlighted the importance water transport within the solid phase at low moisture levels. The NIR data was also successfully used with PCA-based MSPC models for endpoint detection.

CONCLUSIONS: The spectral quality of the small form factor NIR sensor and its robustness is clearly sufficient for the construction and application of PLS models as well as PCA-based MSPC moisture models. The resulting high resolution moisture content signal was successfully used for endpoint detection and monitoring the mass transfer rate.

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