Process Analytical Technology

Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries
Herausgeber: Bakeev, Katherine A

• Gebundenes Buch

Produktbeschreibung

Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: * Overview, Implementation and Sampling in Process Analytical Technologies * UV-Visible Spectroscopy for On-line Analysis * Near-infrared, NIR Chemical Imaging, Infrared, Raman and Process NMR Spectroscopy for Process Analytical Applications * Fluorescent Sensing and Process Analytical Applications * Chemometrics in Process Analytical Technology (PAT) * NIR Spectroscopy: Off-line and At-line Applications in the Pharmaceutical Industry * NIR in the Chemical Industry: Added Value and Implementation Challenges * Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition "The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology." Current Engineering Practice

Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 592
• Erscheinungstermin: 14. Juni 2010
• Englisch
• Abmessung: 251mm x 196mm x 36mm
• Gewicht: 1256g
• ISBN-13: 9780470722077
• ISBN-10: 047072207X
• Artikelnr.: 28163192

Autorenporträt

Katherine A. Bakeev is Principal Scientist with GlaxoSmithKline in King of Prussia, PA where she works in the Process Analytics and Chemometrics group supporting chemical development. She has twelve years of industrial experience including work in process analytical chemistry with ISP, and as a product specialist for Foss NIRSystems. She holds a PhD in Polymer Science and Engineering from the University of Massachusetts in Amherst, and a Masters in Technology Management from Stevens Institute of Technology. She has given numerous presentations on the use of near-infrared spectroscopy (NIR), and in 2007 received the Coblentz Society Craver Award for her work in NIR and chemometrics.

Inhaltsangabe

Preface to the Second Edition. List of Contributors. List of Abbreviations.
1 Overview of Process Analysis and PAT (Jason E. Dickens). 1.1
Introduction. 1.2 Execution of Process Analysis Projects. 1.3 Process
Instrumentation. 1.4 Conclusions. 1.5 Glossary of Acronyms and Terms. 2
Implementation of Process Analytical Technologies (Robert Guenard and Gert
Thurau). 2.1 Introduction to Implementation of Process Analytical
Technologies (PAT) in the Industrial Setting. 2.2 Generalized Process
Analytics Work Process. 2.3 Considerations for PAT Implementation in the
Pharmaceutical Industry. 2.4 Conclusions. 3 Process Sampling: Theory of
Sampling - the Missing Link in Process Analytical Technologies (PAT) (Kim
H. Esbensen and Peter Paasch-Mortensen). 3.1 Introduction. 3.2 Theory of
Sampling - Introduction. 3.3 Mass Reduction as a Specifi c Sampling
Procedure. 3.4 Fundamental Sampling Principle. 3.5 Sampling - a Very
Practical Issue. .6 Reactors and Vessels - Identical Process Sampling
Issues. 3.7 Heterogeneity Characterization of 1-D lots: Variography. 3.8
Data Quality - New Insight from the TOS. 3.9 Validation in Chemometrics and
PAT. 3.10 Summary. 4 UV-visible Spectroscopy for On-line Analysis (Marcel
A. Liauw, Lewis C. Baylor and Patrick E. O'Rourke). 4.1 Introduction. 4.2
Theory. 4.3 Instrumentation. 4.4 Sample Interface. 4.5 Implementation. 4.6
Applications. 4.7 Detailed Application Notes. 4.8 Conclusion. 5
Near-infrared Spectroscopy for Process Analytical Technology: Theory,
Technology and Implementation (Michael B. Simpson). 5.1 Introduction. 5.2
Theory of Near-infrared Spectroscopy. 5.3 Analyser Technologies in the
Near-infrared. 5.4 The Sampling Interface. 5.5 Practical Examples of
Near-infrared Analytical Applications. 5.6 Conclusion. 6 Infrared
Spectroscopy for Process Analytical Applications (John P. Coates). 6.1
Introduction. 6.2 Practical Aspects of IR Spectroscopy. 6.3 Instrumentation
Design and Technology. 6.4 Process IR Instrumentation. 6.5 Applications of
Process IR Analyzers. 6.6 Process IR Analyzers: a Review. 6.7 Trends and
Directions. 7 Raman Spectroscopy (Nancy L. Jestel). 7.1 Attractive Features
of Raman Spectroscopy. 7.2 Potential Issues with Raman Spectroscopy. 7.3
Fundamentals of Raman Spectroscopy. 7.4 Raman Instrumentation. 7.5
Quantitative Raman. 7.6 Applications. 7.7 Current State of Process Raman
Spectroscopy. 8 Near-infrared Chemical Imaging for Product and Process
Understanding (E. Neil Lewis, Joseph W. Schoppelrei, Lisa Makein, Linda H.
Kidder and Eunah Lee). 8.1 The PAT Initiative. 8.2 The Role of
Near-infrared Chemical Imaging (NIR-CI) in the Pharmaceutical Industry. 8.3
Evolution of NIR Imaging Instrumentation. 8.4 Chemical Imaging Principles.
8.5 PAT Applications. 8.6 Processing Case Study: Estimating 'Abundance' of
Sample Components. 8.7 Processing Case Study: Determining Blend Homogeneity
Through Statistical Analysis. 8.8 Final Thoughts. 9 Acoustic Chemometric
Monitoring of Industrial Production Processes (Maths Halstensen and Kim H.
Esbensen). 9.1 What is Acoustic Chemometrics? 9.2 How Acoustic Chemometrics
Works. 9.3 Industrial Production Process Monitoring. 9.4 Available On-line
Acoustic Chemometric Equipment. 9.5 Discussion. 9.6 Conclusions. 10 Process
NMR Spectroscopy: Technology and On-line Applications (John C. Edwards and
Paul J. Giammatteo). 10.1 Introduction. 10.2 NMR Spectroscopy Overview.
10.3 Process NMR Instrumentation. 10.4 Postprocessing Methodologies for NMR
Data. 10.5 Advantages and Limitations of NMR as a Process Analytical
Technology. 10.6 On-line and At-line Applications. 10.7 Current Development
and Applications. 10.8 Conclusions. 11 Fluorescent Sensing and Process
Analytical Applications (Jason E. Dickens). 11.1 Introduction. 11.2
Luminescence Fundamentals. 11.3 LIF Sensing Fundamentals. 11.4 LIF Sensing
Instrumentation. 11.5 Luminescent Detection Risks. 11.6 Process Analytical
Technology Applications. 11.7 Conclusions. 12 Chemometrics in Process
Analytical Technology (PAT) (Charles E. Miller). 12.1 Introduction. 12.2
Foundations of Chemometrics. 12.3 Chemometric Methods in PAT. 12.4 Overfi
tting and Model Validation. 12.5 Outliers. 12.6 Calibration Strategies in
PAT. 12.7 Sample and Variable Selection in Chemometrics. 12.8
Troubleshooting/Improving an Existing Method. 12.9 Calibration Transfer and
Instrument Standardization. 12.10 Chemometric Model Deployment Issues in
PAT. 12.11 People Issues. 12.12 The Final Word. 13 On-line PAT Applications
of Spectroscopy in the Pharmaceutical Industry (Brandye Smith-Goettler).
13.1 Background. 13.2 Reaction Monitoring. 13.3 Crystallization. 13.4 API
Drying. 13.5 Nanomilling. 13.6 Hot-melt Extrusion. 13.7 Granulation. 13.8
Powder Blending. 13.9 Compression. 13.10 Coating. 13.11 Biologics. 13.12
Cleaning Validation. 13.13 Conclusions. 14 NIR spectroscopy in
Pharmaceutical Analysis: Off-line and At-line PAT Applications (Marcelo
Blanco Romía and Manel Alcalá Bernárdez). 14.1 Introduction. 14.2
Foundation of Qualitative Method Development. 14.3 Foundation of
Quantitative Method Development. 14.4 Method Validation. 14.5 Calibration
Transfer. 14.6 Pharmaceutical Applications. 14.7 Conclusions. 15
Near-infrared Spectroscopy (NIR) as a PAT Tool in the Chemical Industry:
Added Value and Implementation Challenges (Ann M. Brearley and Susan J.
Foulk). 15.1 Introduction. 15.2 Successful Process Analyzer Implementation.
15.3 Example Applications. 16 Future Trends for PAT for Increased Process
Understanding and Growing Applications in Biomanufacturing (Katherine A.
Bakeev and Jose C. Menezes). 16.1 Introduction. 16.2 Regulatory Guidance
and its Impact on PAT. 16.3 Going Beyond Process Analyzers Towards
Solutions. 16.4 Emerging Application Areas of PAT. 16.5 New and Emerging
Sensor and Control Technologies. 16.6 Advances in Sampling: NeSSI. 16.7
Challenges Ahead. 16.8 Conclusion. References. Index.