Author, as appears in the article.: Avila, Claudio R.; Ferre, Joan; de Oliveira, Rodrigo Rocha; de Juan, Anna; Sinclair, Wayne E.; Mahdi, Faiz M.; Hassanpour, Ali; Hunter, Timothy N.; Bourne, Richard A.; Muller, Frans L.;

Department: Química Analítica i Química Orgànica

URV's Author/s: Ferré Baldrich, Joan

Keywords: Online process monitoring Near infrared spectroscopy Mems fabry-pérot interferometer sensor Mass transfer resistance Fluidised bed drying near infrared spectroscopy mems fabry-pérot interferometer sensor mass transfer resistance fluidised bed drying

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-Perot 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.

Thematic Areas: Saúde coletiva Química Pharmacology (medical) Pharmacology & pharmacy Pharmacology Pharmaceutical science Organic chemistry Odontología Molecular medicine Medicina veterinaria Medicina ii Medicina i Materiais Interdisciplinar General medicine Farmacia Engenharias ii Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Chemistry, multidisciplinary Chemistry Biotecnología Biotechnology Astronomia / física

licence for use: https://creativecommons.org/licenses/by/3.0/es/

ISSN: 07248741

Author's mail: joan.ferre@urv.cat

Author identifier: 0000-0001-6240-413X

Record's date: 2023-02-19

Papper version: info:eu-repo/semantics/publishedVersion

Link to the original source: https://link.springer.com/article/10.1007/s11095-020-02787-y

Licence document URL: http://repositori.urv.cat/ca/proteccio-de-dades/

Papper original source: Pharmaceutical Research. 37 (5): 84-

APA: Avila, Claudio R.; Ferre, Joan; de Oliveira, Rodrigo Rocha; de Juan, Anna; Sinclair, Wayne E.; Mahdi, Faiz M.; Hassanpour, Ali; Hunter, Timothy N.; Bo (2020). Process Monitoring of Moisture Content and Mass Transfer Rate in a Fluidised Bed with a Low Cost Inline MEMS NIR Sensor. Pharmaceutical Research, 37(5), 84-. DOI: 10.1007/s11095-020-02787-y

Article's DOI: 10.1007/s11095-020-02787-y

Entity: Universitat Rovira i Virgili

Journal publication year: 2020

Publication Type: Journal Publications