Introduction to Process Analytics for Pharmaceuticals

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 Gennas, University of Helsinki 11. Microscopy (optical imaging) + machine vision Sami Svanback, 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 (Abo) 17. Protein case t.b.d. 18. Regulatory development Stephanie Choi, FDA

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• Tecnologia farmacêutica
• Química analítica