Process analytical technology: spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries

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 forPAT for Increased Process Understanding and Growing Applications in Biomanufacturing. This volume is an important starting point for anyone wanting to implementPAT 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 activein the field of Process Analytical Technology." - Current Engineering Practice. INDICE: 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: Theoryof 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. 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. Chapter7: Raman Spectroscopy. Dr. Nancy L. Jestel. . 7.1 Attractive features of Raman spectroscopy. 7.2 Potential issues with Raman spectroscopy. 7.3 Fundamentalsof Raman spectroscopy. 7.4 Raman instrumentation. 7.5 Quantitative Raman. 7.6Applications. 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 Processingcase 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. 10.2 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 analyticaltechnology. 10.6 On-line and at-line applications. 10.7 Current Development and Applications. 10.8 Conclusions. References. Chapter 11: Fluorescent Sensingand 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 inProcess 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 thePharmaceutical 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 Romía. 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. 14.6Pharmaceutical 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. 16.1Introduction. 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(TM). 16.7 Challenges Ahead. 16.8 Conclusion. References

• ISBN: 978-0-4707-2207-7
• Editorial: John Wiley & Sons
• Encuadernacion: Rústica
• Páginas: 576
• Fecha Publicación: 01/04/2010
• Nº Volúmenes: 1
• Idioma: Inglés