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Process analytical technology : spectroscopic tools and implemented strategies for the chemical and pharmaceutical industries / edited by Katherine A. Bakeev.

Contributor(s): Material type: TextTextPublication details: Chichester, West Sussex : Wiley, 2010.Edition: 2nd edDescription: 1 online resource (xxiv, 557 pages) : illustrationsContent type:
Media type:
Carrier type:
ISBN:
  • 9780470689608 (electronic bk.)
  • 0470689609 (electronic bk.)
Subject(s): Additional physical formats: No titleDDC classification:
  • 660.2 22
LOC classification:
  • .P737 2010
NLM classification:
  • QV 744
Online resources:
Contents:
Machine generated contents note: Chapter 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 Glossy of Acronyms and Terms -- 1.6 References -- Chapter 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 -- 2.5 References -- Chapter 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 TOS -- introduction -- 3.3 Mass reduction as a specific sampling procedure -- 3.4 Fundamental Sampling Principle (FSP) -- 3.5 Sampling -- a very practical issue -- 3.6 Reactors vessels -- identical process sampling issues -- 3.7 Heterogeneity characterisaton 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 -- Chapter 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 -- References -- Chapter 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 -- References.
Chapter 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 -- Abbreviations and Acronyms -- References -- Chapter 7 -- Raman Spectroscopy -- Dr. 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 -- 7.8 References -- Chapter 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 one: estimating 'abundance' of sample components -- 8.7 Processing case study two: determining blend homogeneity through statistical analysis -- 8.8 Final thoughts -- Acknowledgements -- Chapter 9: -- Acoustic chemometric monitoring of industrial production processes -- Maths Halstensen & 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 -- 9.7 References -- Chapter 10 -- Process NMR Spectroscopy: Technology and On-line Applications -- John C. Edwards, Ph. D. and Paul J. Giammatteo, Ph. D. -- 10.1 Introduction -- 10.2NMR 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.
Chapter 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 -- References -- Chapter 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 Overfitting 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 -- Chapter 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 -- References -- Chapter 14 -- NIR spectroscopy in pharmaceutical analysis: Off-line and At-line PAT Applications -- Prof. Marcelo Blanco Romi;a -- 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 -- Chapter 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 -- Chapter 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[trademark symbol] -- 16.7 Challenges Ahead -- 16.8 Conclusion -- References.
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IT Carlow ebook

Includes bibliographical references and index.

Machine generated contents note: Chapter 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 Glossy of Acronyms and Terms -- 1.6 References -- Chapter 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 -- 2.5 References -- Chapter 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 TOS -- introduction -- 3.3 Mass reduction as a specific sampling procedure -- 3.4 Fundamental Sampling Principle (FSP) -- 3.5 Sampling -- a very practical issue -- 3.6 Reactors vessels -- identical process sampling issues -- 3.7 Heterogeneity characterisaton 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 -- Chapter 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 -- References -- Chapter 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 -- References.

Chapter 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 -- Abbreviations and Acronyms -- References -- Chapter 7 -- Raman Spectroscopy -- Dr. 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 -- 7.8 References -- Chapter 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 one: estimating 'abundance' of sample components -- 8.7 Processing case study two: determining blend homogeneity through statistical analysis -- 8.8 Final thoughts -- Acknowledgements -- Chapter 9: -- Acoustic chemometric monitoring of industrial production processes -- Maths Halstensen & 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 -- 9.7 References -- Chapter 10 -- Process NMR Spectroscopy: Technology and On-line Applications -- John C. Edwards, Ph. D. and Paul J. Giammatteo, Ph. D. -- 10.1 Introduction -- 10.2NMR 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.

Chapter 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 -- References -- Chapter 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 Overfitting 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 -- Chapter 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 -- References -- Chapter 14 -- NIR spectroscopy in pharmaceutical analysis: Off-line and At-line PAT Applications -- Prof. Marcelo Blanco Romi;a -- 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 -- Chapter 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 -- Chapter 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[trademark symbol] -- 16.7 Challenges Ahead -- 16.8 Conclusion -- References.

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