Sebastian Ziewer Arndts
Analyticon Instruments GmbH, Germany
Biography
Sebastian Ziewer Arndts completed his Diploma in Biology at University of Bonn from 2000-2006; he was scientific employee from 2006-2012 and completed his PhD thesis at University Hospital Bonn in 2012. His thesis was about “Immunological mechanisms and vaccination strategies in the murine model of human lymphatic filariasis”. He has been Trainer and Technical Consultant for XRF, NIR, FT-IR, and Raman spectroscopy at Bio-Chem division of Analyticon Instruments GmbH since 2012. He focuses on “Quality control in the chemical and pharmaceutical industry”.
Abstract
Efficiency is essential in the field of pharmaceutical production as regulatory guidelines are getting tougher and tougher. Therefore processes need to be optimized in order to use the given resources in the best possible way. The new and unique transmission Raman-spectrometer TRS100 ensures increased product safety during content uniformity tests, while simultaneously saving 60-90% of operating costs compared to the commonly used HPLC. With the TRS, the measurement time for one sample is under one second. Measurement itself is completely non-destructive, making considerably more measurements possible and substantially reducing release time. In contrast to HPLC the analysis is completely non-destructive, needs to sample preparation and the results are not user dependent, but even transferable from one instrument to another. This new and modern analytical approach to content uniformity testing will also be helpful when it comes to continuous manufacturing. Integrating such a device into a process will ensure that the quality is consistent and the final release can easily and reliably be done. In addition to the high through put and the time saving approach the instrument has only very little maintenance costs and no consumables in contrast to the normal HPLC analysis that is very costly. As Raman is also sensitive for polymorphous substances this kind of testing is also useful for this. The speech shows how this new approach can be a revolution for the pharmaceutical world as far as cost and time saving is concerned. In addition, it is explained how the transmission technology ensures extremely selective results and how easy model building is.