Process Analytical Technology 1st Edition by Katherine A Bakeev ISBN 1405121033 9781405121033

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ISBN 10: 1405121033 
ISBN 13: 9781405121033
Author: Katherine A Bakeev

Process Analytical Technology (PAT), as introduced in this landmark volume edited by Katherine A. Bakeev, is a framework for designing, analyzing, and controlling pharmaceutical manufacturing through timely measurements of critical quality and performance attributes.

The book is grounded in the U.S. FDA’s PAT initiative, which encourages pharmaceutical companies to enhance manufacturing and product quality using scientific, risk-based, and data-driven approaches. The core idea is to build quality into the product, not just test for it at the end.

Process Analytical Technology 1st Table of contents:

Chapter 1 – Overview of Process Analysis and PAT

• introduction

• execution of process analysis projects

• process instrumentation

• conclusions

• glossary of acronyms and terms

Chapter 2 – Implementation of Process Analytical Technologies

• introduction to implementation of PAT in the industrial setting

• generalized process analytics work process

• considerations for PAT implementation in the pharmaceutical industry

• conclusions

Chapter 3 – Process Sampling: Theory of Sampling – the Missing Link in PAT

• introduction

• theory of sampling – introduction

• mass reduction as a specific sampling procedure

• fundamental sampling principle

• sampling – a very practical issue

• reactors and vessels – identical process sampling issues

• heterogeneity characterization of 1-D lots: variography

• data quality – new insight from the theory of sampling

• validation in chemometrics and PAT

• summary

Chapter 4 – UV-Visible Spectroscopy for On-Line Analysis

• introduction

• theory

• instrumentation

• sample interface

• implementation

• applications

• detailed application notes

• conclusion

Chapter 5 – Near-Infrared Spectroscopy for PAT: Theory, Technology and Implementation

• introduction

• theory of near‑infrared spectroscopy

• analyser technologies in the near‑infrared

• the sampling interface

• practical examples of near‑infrared analytical applications

• conclusion

Chapter 6 – Infrared Spectroscopy for Process Analytical Applications

• introduction

• practical aspects of IR spectroscopy

• instrumentation design and technology

• process IR instrumentation

• applications of process IR analyzers

• process IR analyzers: a review

• trends and directions

Chapter 7 – Raman Spectroscopy

• attractive features of Raman spectroscopy

• potential issues with Raman spectroscopy

• fundamentals of Raman spectroscopy

• Raman instrumentation

• quantitative Raman

• applications

• current state of process Raman spectroscopy

Chapter 8 – Near‑Infrared Chemical Imaging for Product and Process Understanding

• the PAT initiative

• the role of NIR-CI in the pharmaceutical industry

• evolution of NIR imaging instrumentation

• chemical imaging principles

• PAT applications

• case study: estimating ‘abundance’ of sample components

• case study: determining blend homogeneity through statistical analysis

• final thoughts

Chapter 9 – Acoustic Chemometric Monitoring of Industrial Production Processes

• what is acoustic chemometrics?

• how acoustic chemometrics works

• industrial production process monitoring

• available on-line acoustic chemometric equipment

• discussion

• conclusions

Chapter 10 – Process NMR Spectroscopy: Technology and On-Line Applications

• introduction

• NMR spectroscopy overview

• process NMR instrumentation

• postprocessing methodologies for NMR data

• advantages and limitations of NMR as a PAT tool

• on-line and at-line applications

• current development and applications

• conclusions

Chapter 11 – Fluorescent Sensing and Process Analytical Applications

• introduction

• luminescence fundamentals

• LIF sensing fundamentals

• LIF sensing instrumentation

• luminescent detection risks

• PAT applications

• conclusions

Chapter 12 – Chemometrics in Process Analytical Technology (PAT)

• introduction

• foundations of chemometrics

• chemometric methods in PAT

• overfitting and model validation

• outliers

• calibration strategies in PAT

• sample and variable selection in chemometrics

• troubleshooting/improving an existing method

• calibration transfer and instrument standardization

• chemometric model deployment issues in PAT

• people issues

• the final word

Chapter 13 – On‑Line PAT Applications of Spectroscopy in the Pharmaceutical Industry

• background

• reaction monitoring

• crystallization

• API drying

• nanomilling

• hot‑melt extrusion

• granulation

• powder blending

• compression

• coating

• biologics

• cleaning validation

• conclusions

Chapter 14 – NIR Spectroscopy in Pharmaceutical Analysis: Off‑Line and At‑Line PAT Applications

• introduction

• foundation of qualitative method development

• foundation of quantitative method development

• method validation

• calibration transfer

• pharmaceutical applications

• conclusions

Chapter 15 – Near‑Infrared Spectroscopy (NIR) as a PAT Tool in the Chemical Industry: Added Value and Implementation Challenges

• introduction

• successful process analyzer implementation

• example applications

Chapter 16 – Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing

• introduction

• regulatory guidance and its impact on PAT

• going beyond process analyzers towards solutions

• emerging application areas of PAT

• new and emerging sensor and control technologies

• advances in sampling: NeSSI™

• challenges ahead

• conclusion

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Tags: Katherine A Bakeev, Analytical Technology