52 SPECTROSCOPY


Enabling technology for QUALITY BY DESIGN


UV-VIS spectroscopy presents new opportunities for inline control in pharmaceutical extrusion, explains Jan H. Johnsen


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Modern manufacturing methods demand better inline monitoring


doption by the


pharmaceutical industry of hot melt extrusion


and wet granulations as new production methods has triggered a parallel search for better inline monitoring systems to control


the manufacturing process and meet regulatory demands. Regulatory bodies on both sides of the Atlantic focus on applying quality by design (QbD) to the range of activities starting with product development and ending with manufacturing. Process analytical technology control tools that are up to the task are essential to achieve the regulatory targets for the control of critical quality attributes.


The old-fashioned method of working Collection and laboratory analysis of samples is an inadequate and time-consuming approach. A limited range of


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NIR and Raman spectroscopy measurement systems have been available previously, but these systems can be cumbersome to work with and the results achieved have not given a broad enough control over the process to be considered a complete PAT solution. Te German company


ColVisTec has taken a different approach and now offers inline process control systems based on UV-VIS spectroscopy. Te company’s design approach is to build systems that are very robust and with stable performance, allowing for longer intervals between calibration cycles. Tis approach builds on ColVisTec’s experience as a


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