Smith / Fissore Process Analytical Technology for Pharmaceutical Freeze-Drying

1. Auflage 2026
ISBN: 978-3-527-85029-7
Verlag: Wiley-VCH
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 489 Seiten, E-Book

Provides insights into an essential pharmaceutical process technology and shows the reader how proper monitoring can enable their process development and guarantee product quality.

Autoren/Hrsg.

Smith, Geoff

Fissore, Davide

Inhaltsverzeichnis

1. Freeze-drying of parenteral drug products - An Introduction
2. Standard PAT instrumentation: Temperature sensors
3. Standard PAT instrumentation: Pressure gauges and vapour pressure sensors
4. Wireless sensor networks for lyophilization
5. Monitoring methods based on the measure of the sublimation flow: Pressure Rise Test and other direct technologies
6. Spectroscopic-based PAT in freeze-drying
7. An introduction to Through-Vial Impedance Spectroscopy (TVIS)
8. An application for Through-Vial Impedance Spectroscopy (TVIS) in modelling of the ice sublimation process
9. Freeze-drying monitoring and control using thermal imaging
10. Multiplexing PAT for qualitative ice sublimation monitoring in primary drying
11. Emerging technologies in pharmaceutical freeze-drying
12. Innovations in control of freezing in pharmaceutical processes

Über Autor(innen)

Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focuses on pharmaceutical applications for impedance/dielectric spectroscopy. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates, and end points. More recently, this research has extended to the multiplexing of other PAT systems alongside the TVIS technology, with the addition of near-infrared and Raman spectroscopy. He is author or co-author of 45 papers in international peer reviewed journals, 2 book chapters, 2 patents, and >100 podium and posters presentations at international conferences.
 
Davide Fissore is Full Professor at Politecnico di Torino (Italy). His research activity is mainly focused on process modelling and optimisation, and on the design and validation of model-based tools for process monitoring and control. One of the topics of this research is the freeze-drying of pharmaceuticals and foodstuffs. In particular, he has proposed various devices to monitor and optimise in-line (using a control system) or offline (using the design space of the product) the freeze-drying process for a given product. Davide Fissore is author or co-author of about 115 papers appeared in international peer reviewed journals, 20 book chapters, and 95 papers appeared on proceedings international conferences. He is also member of the International Society for Lyophilization and Freeze-Drying and member of the Editorial Advisory Board of the Journal of Pharmaceutical Sciences.