SPECTROSCOPY 49
cost of goods and production losses; remote monitoring in hazardous reaction conditions; ability to control the reaction based on real-time analytics and improved process robustness.
Tablet coating Kaiser has addressed continuous solids monitoring and solid phase unit operations including in situ control of crystallisation and polymorphism, process-induced transformations, low-dose formulations and tablet coating. In a representative application, Kaiser’s PhAT probe was used to monitor an active coating process for pharmaceutical tablets. Active coating process studies in the lab showed that Raman spectroscopy was robust to variations in the probe working distance, enabling representative sampling without focusing the probe. In-process Raman provided a non-invasive measurement without hardware modification, insight into the chemistry of the coating process and could be used for control from on-line measurements that determine optimal coating time. Raman spectroscopy for active coating monitoring has been demonstrated successfully in continuous and batch manufacturing.
Raman spectroscopy within a QbD approach A customer webinar shows practical examples of integrating Raman spectroscopy into a process environment.3
One
example demonstrated coupling in-line Raman spectroscopy with a QbD approach to improving a process reaction. Reaction age
Karen Esmonde-White is with Kaiser Optical Systems.
www.kosi.com
For more information ✔ at
www.scientistlive.com/eurolab
Fig. 2. Comparison of a reaction design space using a fixed post-reaction age (a) and a variable reaction age (b) based on a Raman-defined endpoint. In-process Raman measurements enabled real- time control of the reaction, resulting in a more robust process
post-completion was determined to be a critical process parameter to avoid product degradation and build-up of side products. Based on experience, it was known that the reaction needed to be cooled to <25°C within five hours of the reaction completion. Raman spectroscopy was proposed as an in-line PAT method because the reaction conditions required in line monitoring. Te Raman method was tested on multiple Raman instruments and using different probes to create a robust calibration set. Scale-up performance was tested at limits of the initial design space to address questions regarding scale dependency. Kaiser shows Raman
spectroscopy as a valuable technique for process monitoring and control, with applications in continuous manufacturing and pharmaceutical reaction monitoring. It provides increased process knowledge that enables advanced process monitoring and real-time process control.
For more information ✔ at
www.scientistlive.com/eurolab
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