Process Analytics for Pharmaceuticals

J Rantanen (Autor)

Buch | Hardcover

500 Seiten

2018
Wiley-Blackwell (an imprint of John Wiley & Sons Ltd) (Verlag)
978-1-119-43302-6 (ISBN)

Infos

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.

Inhalt

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

Produkt-Details

• Erscheinungsdatum: 07.05.2019
• Verlagsort: Chicester
• Sprache: englisch
• Maße: 170 x 244 mm
• Themenwelt: Naturwissenschaften ► Chemie ► Analytische Chemie
• Themenwelt: Technik
• ISBN-10: 1-119-43302-9 / 1119433029
• ISBN-13: 978-1-119-43302-6 / 9781119433026
• Zustand: Neuware