『英文書』Process Analytical Technology 2E - Spectroscopic Tools And Implementation Strategies For The Chemical And Pharmaceutical Industries（ISBN=9780470722077
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:
Implementationof Process Analytical Technologies
UV-Visible Spectroscopy for On-line Analysis
Infrared Spectroscopy for Process Analytical Applications
Process Raman Spectroscopy
Process NMR Spectrscopy: Technology and On-line
Applications
Fluorescent Sensing and Process Analytical Applications
Chemometrics in Process Analytical Technology PAT
On-Line PAT Applications of Spectroscopy in the Pharmaceutical
Industry
Future Trends for PAT for Increased Process Understanding and
Growing Applications in Biomanufacturing
NIR Chemical Imaging
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
目錄：
Preface to the Second Edition.
List of Contributors.
List of Abbreviations.
1 Overview of Process Analysis and PATJason 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.
References.
2 Implementation of Process Analytical TechnologiesRobert 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.
References.
3 Process Sampling: Theory of Sampling – the Missing Link in
Process Analytical Technologies PATKim H. Esbensen and Peter
Paasch-Mortensen.
3.1 Introduction.
3.2 Theory of Sampling – Introduction.
3.3 Mass Reduction as a Specific Sampling Procedure.
3.4 Fundamental Sampling Principle.
3.5 Sampling – a Very Practical Issue.
3.6 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.
References.
4 UV-visible Spectroscopy for On-line AnalysisMarcel 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.
References.
5 Near-infrared Spectroscopy for Process Analytical Technology:
Theory, Technology and ImplementationMichael 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.
References.
6 Infrared Spectroscopy for Process Analytical ApplicationsJohn 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.
References.
7 Raman SpectroscopyNancy 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.
References.
8 Near-infrared Chemical Imaging for Product and Process
UnderstandingE. 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.
References.
9 Acoustic Chemometric Monitoring of Industrial Production
ProcessesMaths 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.
References.
10 Process NMR Spectroscopy: Technology and On-line
ApplicationsJohn 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.
References.
11 Fluorescent Sensing and Process Analytical ApplicationsJason 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.
References.
12 Chemometrics in Process Analytical Technology PATCharles E.
Miller.
12.1 Introduction.
12.2 Foundations of Chemometrics.
12.3 Chemometric Methods in PAT.
12.4 Overfitting and Model Validation.
12.5 Outliers.
12.6 Calibration Strategies in PAT.
12.7 Sample and Variable Selection in Chemometrics.
12.8 TroubleshootingImproving 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.
References.
13 On-line PAT Applications of Spectroscopy in the Pharmaceutical
IndustryBrandye 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.
References.
14 NIR Spectroscopy in Pharmaceutical Analysis: Off-line and
At-line PAT ApplicationsMarcelo 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.
References.
15 Near-infrared Spectroscopy NIR as a PAT Tool in the Chemical
Industry: Added Value and Implementation ChallengesAnn M. Brearley
and Susan J. Foulk.
15.1 Introduction.
15.2 Successful Process Analyzer Implementation.
15.3 Example Applications.
References.
16 Future Trends for PAT for Increased Process Understanding and
Growing Applications in BiomanufacturingKatherine 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.
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