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Introduction to Process Analytics for Pharmaceuticals

Introduction to Process Analytics for Pharmaceuticals

Jukka Rantanen (Editor), Clare Strachan (Editor), Thomas De Beer (Editor), Jürgen Siepmann (Series Editor), Dionysios Douroumis (Series Editor), Alfred Fahr (Series Editor), Martin J. Snowden (Series Editor), Vladimir Torchilin (Series Editor)

ISBN: 978-1-119-43302-6

Sep 2019

500 pages

Select type: Hardcover

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Description

This book introduces the key toolbox for successful process analytics including basic engineering principles, key sensor technologies, and basic control solutions for pharmaceutical unit operations. The first part discusses principles relevant to the engineering requirements of process analytics, covering terminology, interfaces and sampling. The second part introduces a comprehensive list of the measurement techniques employed ranging from physicochemical properties, over spectroscopic techniques, to specialized techniques such as tomography and acoustic monitoring. The final part of the book showcases concrete examples of process analytics in a chemical, biochemical/pharmaceutical and regulatory context in traditional and newly developed processes.

PART 0 Introduction, motivation

De Beer, Rantanen, Strachan

 

 

PART I General engineering principles

 

1. Process interfacing,

De Beer, Rantanen

- in/on/at –line, terminology

- theory of sampling, light-matter interactions (in the case of spectroscopy)

- sampling window structures  

 

2. General introduction to process control

Khinast (TU Graz)

- sensor principles

- connection to control system

- control systems

 

3. Analytical method development

Hubert (Liege, Belgium)

- modify (ICH Q2 + NIR guideline) for process monitoring (selectivity, accuracy …)

- calibration/validation samples (2/3 vs 1/3)

 

4. Multivariate data analysis

Bro (Copenhagen)

- PCA, PLS and other linear methods

- non-linear

 

PART II Measurement techniques

5. “Standard” methods, univariate

Jos Corver, RheaVita

Temperature, pressure, pH, force, flow rate (gas, solid, liquid)

 

6. Fermentation Gas phase analysis (O2 etc)

Jarkka Glassey, Newcastle

 

7. Spectroscopic techniques, Infrared (IR) spectroscopy + NIR, THz

De Beer (Ghent, Belgium)

 

8. Spectroscopic techniques, Raman spectroscopy

Rantanen (Copenhagen, Denmark)

 

9. Chemical mapping, spectral mapping 

Strachan (Helsinki, Finland)

 

10. Wet chemistry, HPLC / MS / NMR

Gustav Boije af Gennäs, University of Helsinki

 

11. Microscopy (optical imaging) + machine vision 

Sami Svanbäck, University of Helsinki

 

12. Particle size - diffraction based methods (laser diffraction), particle velocimetry/tracking/chord length

t.b.d.

 

13. Tomography, X ray CT, THz

Zeitler, Cambridge

 

14. Acoustic monitoring, ultrasound

Simo-Pekka Simonaho, University of Eastern Finland

 

PART III Applications / Examples

15. Small molecule case – traditional powder lines

de Beer and Ketolainen

 

16. Small molecule case – innovative line, 2D / 3D printing

Sandler and Rantanen (Åbo)

 

17. Protein case

t.b.d.

 

18. Regulatory development

Stephanie Choi, FDA