Process Analytical Technology for Pharmaceutical Freeze-Drying

1. Auflage 2026
ISBN: 978-3-527-35465-8
Verlag: Wiley-VCH GmbH

Buch, Englisch, 480 Seiten, Format (B × H): 170 mm x 244 mm

Case studies and insights into an essential pharmaceutical process technology

Process Analytical Technology for Pharmaceutical Freeze-Drying provides a comprehensive and up-to-date overview of the currently existing techniques for freeze-drying monitoring with case studies included throughout. Innovation related to advances in freeze-drying methods (e.g. spray or continuous freeze-drying), as well as to multiplexing PAT, besides spectroscopic, impedance-based methods and thermal imaging methods, are addressed.

The use of such techniques at lab-scale for process development, and at industrial scale to guarantee product quality during manufacturing, is also discussed. Strengths and drawbacks of several methods are presented in such a way that freeze-drying practitioners could identify the best solution for their own application.

Sample topics explored in Process Analytical Technology for Pharmaceutical Freeze-Drying include: - Temperature as a critical process parameter in pharmaceutical freeze-drying, focusing on how it is measured, interpreted, and applied to process control
- Design and function of the capacitance manometer and the Pirani gauge and the relationship between ice interface vapor pressure and ice interface a temperature
- Wireless sensors to monitor the freeze-drying process, overcoming some limitations of wired probes, with emphasis on those capable of measuring temperature, pressure, and vial strain
- Methods based on the pressure rise test (PRT) to evaluate, at first, product temperature, and then, the sublimation flux, as well as the heat and mass transfer coefficients

Providing insights into an essential pharmaceutical process technology, Process Analytical Technology for Pharmaceutical Freeze-Drying enables engineers and chemists across disciplines to enable their process development and guarantee product quality through proper monitoring.

Autoren/Hrsg.

Smith, Geoff

Fissore, Davide

Fachgebiete

• Naturwissenschaften Chemie Analytische Chemie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Chemische Verfahrenstechnik
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie

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.