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.
Table of Contents:
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
About the Author :
Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University, UK. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool.
Davide Fissore is Full Professor at Politecnico di Torino, Italy. He is a member of the International Society for Lyophilization and Freeze-Drying and member of the Editorial Advisory Board of the Journal of Pharmaceutical Sciences.
