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| Preface to the Second Edition | |
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| List of Contributors | |
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| List of Abbreviations | |
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| Overview of Process Analysis and PAT | |
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| Introduction | |
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| Execution of Process Analysis Projects | |
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| Process Instrumentation | |
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| Conclusions | |
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| Glossary of Acronyms and Terms | |
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| Implementation of Process Analytical Technologies | |
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| Introduction to Implementation of Process Analytical Technologies (PAT) in the Industrial Setting | |
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| Generalized Process Analytics Work Process | |
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| Considerations for PAT Implementation in the Pharmaceutical Industry | |
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| Conclusions | |
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| Process Sampling: Theory of Sampling - the Missing Link in Process Analytical Technologies (PAT) | |
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| Introduction | |
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| Theory of Sampling - Introduction | |
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| Mass Reduction as a Specifi c Sampling Procedure | |
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| Fundamental Sampling Principle | |
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| Sampling - a Very Practical Issue | |
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| Reactors and Vessels - Identical Process Sampling Issues | |
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| Heterogeneity Characterization of 1-D lots: Variography | |
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| Data Quality - New Insight from the TOS | |
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| Validation in Chemometrics and PAT | |
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| Summary | |
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| UV-visible Spectroscopy for On-line Analysis | |
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| Introduction | |
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| Theory | |
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| Instrumentation | |
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| Sample Interface | |
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| Implementation | |
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| Applications | |
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| Detailed Application Notes | |
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| Conclusion | |
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| Near-infrared Spectroscopy for Process Analytical Technology: Theory, Technology and Implementation | |
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| Introduction | |
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| Theory of Near-infrared Spectroscopy | |
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| Analyser Technologies in the Near-infrared | |
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| The Sampling Interface | |
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| Practical Examples of Near-infrared Analytical Applications | |
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| Conclusion | |
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| Infrared Spectroscopy for Process Analytical Applications | |
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| Introduction | |
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| Practical Aspects of IR Spectroscopy | |
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| Instrumentation Design and Technology | |
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| Process IR Instrumentation | |
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| Applications of Process IR Analyzers | |
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| Process IR Analyzers: a Review | |
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| Trends and Directions | |
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| Raman Spectroscopy | |
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| Attractive Features of Raman Spectroscopy | |
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| Potential Issues with Raman Spectroscopy | |
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| Fundamentals of Raman Spectroscopy | |
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| Raman Instrumentation | |
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| Quantitative Raman | |
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| Applications | |
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| Current State of Process Raman Spectroscopy | |
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| Near-infrared Chemical Imaging for Product and Process Understanding | |
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| The PAT Initiative | |
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| The Role of Near-infrared Chemical Imaging (NIR-CI) in the Pharmaceutical Industry | |
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| Evolution of NIR Imaging Instrumentation | |
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| Chemical Imaging Principles | |
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| PAT Applications | |
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| Processing Case Study: Estimating 'Abundance' of Sample Components | |
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| Processing Case Study: Determining Blend Homogeneity Through Statistical Analysis | |
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| Final Thoughts | |
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| Acoustic Chemometric Monitoring of Industrial Production Processes | |
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| What is Acoustic Chemometrics? | |
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| How Acoustic Chemometrics Works | |
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| Industrial Production Process Monitoring | |
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| Available On-line Acoustic Chemometric Equipment | |
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| Discussion | |
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| Conclusions | |
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| Process NMR Spectroscopy: Technology and On-line Applications | |
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| Introduction | |
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| NMR Spectroscopy Overview | |
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| Process NMR Instrumentation | |
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| Postprocessing Methodologies for NMR Data | |
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| Advantages and Limitations of NMR as a Process Analytical Technology | |
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| On-line and At-line Applications | |
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| Current Development and Applications | |
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| Conclusions | |
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| Fluorescent Sensing and Process Analytical Applications | |
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| Introduction | |
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| Luminescence Fundamentals | |
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| LIF Sensing Fundamentals | |
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| LIF Sensing Instrumentation | |
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| Luminescent Detection Risks | |
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| Process Analytical Technology Applications | |
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| Conclusions | |
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| Chemometrics in Process Analytical Technology (PAT) | |
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| Introduction | |
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| Foundations of Chemometrics | |
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| Chemometric Methods in PAT | |
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| Overfi tting and Model Validation | |
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| Outliers | |
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| Calibration Strategies in PAT | |
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| Sample and Variable Selection in Chemometrics | |
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| Troubleshooting/Improving an Existing Method | |
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| Calibration Transfer and Instrument Standardization | |
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| Chemometric Model Deployment Issues in PAT | |
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| People Issues | |
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| The Final Word | |
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| On-line PAT Applications of Spectroscopy in the Pharmaceutical Industry | |
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| Background | |
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| Reaction Monitoring | |
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| Crystallization | |
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| API Drying | |
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| Nanomilling | |
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| Hot-melt Extrusion | |
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| Granulation | |
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| Powder Blending | |
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| Compression | |
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| Coating | |
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| Biologics | |
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| Cleaning Validation | |
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| Conclusions | |
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| NIR spectroscopy in Pharmaceutical Analysis: Off-line and At-line PAT Applications | |
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| Introduction | |
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| Foundation of Qualitative Method Development | |
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| Foundation of Quantitative Method Development | |
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| Method Validation | |
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| Calibration Transfer | |
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| Pharmaceutical Applications | |
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| Conclusions | |
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| Near-infrared Spectroscopy (NIR) as a PAT Tool in the Chemical Industry: Added Value and Implementation Challenges | |
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| Introduction | |
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| Successful Process Analyzer Implementation | |
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| Example Applications | |
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| Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing | |
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| Introduction | |
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| Regulatory Guidance and its Impact on PAT | |
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| Going Beyond Process Analyzers Towards Solutions | |
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| Emerging Application Areas of PAT | |
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| New and Emerging Sensor and Control Technologies | |
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| Advances in Sampling: NeSSI | |
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| Challenges Ahead | |
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| Conclusion | |
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| References | |
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| Index | |