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Full Description
The advancement and application of process analytical technology (PAT) in pharmaceutical manufacturing represents a complex task, requiring an understanding of both historical developments and modern technological methods. This book provides a comprehensive overview of the current use of various analytical tools and methods within the industry and how they can be applied to PAT. It covers topics such as sampling innovation, statistical process control, and the utilization of chemometrics, all pivotal for maintaining and improving product quality. The text delves into methods like near-infrared spectroscopy, Raman spectroscopy, and spectrophotometry, discussing their principles, applications, and benefits in real-time monitoring and process control. It provides an insight into the continuous manufacturing of solid oral dosage forms, highlighting regulatory considerations and the integration of PAT for enhanced product quality and efficiency. Furthermore, the book explores the role of sensors, liquid chromatography, and mass spectrometry as essential components in monitoring and optimizing manufacturing processes. Unique to this book are the practical examples and case studies that illustrate the implementation of PAT tools across different phases of pharmaceutical development. This makes it an invaluable resource for pharmaceutical scientists, engineers, and technicians, as well as researchers and advanced students in related fields, offering direct insights into innovative practices and the future direction of pharmaceutical manufacturing.
Contents
1. From Benchtop to Manufacturing...
Gregory K. Webster, Greg D. Doddridge, and Laila Kott
2. Sampling the Critical "Before Analysis" Domain
Rodolfo J. Romañach and Kim H. Esbensen
3. Optimizing Good Pharmaceutical Practice through Statistical Process Control
Mostafa Essam Eissa
4. Chemometrics for PAT
Zhenqi Shi and Benoit Igne
5. Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms
John Wahlich
6. Sensors in PAT
Charu Pandey
7. Process NIR
Philip Doherty and Owen Rehrauer
8. The Use of Raman Spectroscopy in Pharmaceutical PAT
Bradford B. Behr, Shaun Fraser, and Mark S. Kemper
9. Process Spectrophotometry
Gregory K. Webster
10. Online HPLC as a Process Analytical Technology
Junliang Liu, Yusuke Sato, Paloma Prieto, Vaso Vlachos, and Jason Hein
11. Benchtop NMR in Process Analytical Technology
Anh Le McClain, Blake David Fonda, and Hector Robert
12. Process Headspace Monitoring
James Veale
13. Process Mass Spectrometry
Patrick A. McVey
14. Process FBRM
Wei Li, Wenqing Tian, and Huaiyu Yang
15. Terahertz Spectroscopy in Tablet Manufacturing
Moritz Anuschek, Jukka Rantanen, and J. Axel Zeitler
16. Process Analytical Technology in Bioprocessing
Shailesh Karavadra, Arnaud Di Bitetto, David James, Lin Chen, Juan Villa, Matthew Zustiak, Elizabeth Amoako, David Kuntz, Nimesh Khadka, Lin Zhang, Kevin Broadbelt and Sue Woods
17. Method Validation and Transfer
Greg D. Doddridge
18. Regulatory Consideration for PAT
Laila Kott
