Enabling technology for quality by design

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

Adoption 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 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.

The German company ColVisTec has taken a different approach and now offers inline process control systems based on UV-VIS spectroscopy. The company’s design approach is to build systems that are very robust and with stable performance, allowing for longer intervals between calibration cycles. This approach builds on ColVisTec’s experience as a manufacturer and supplier of inline process control technology to a range of manufacturing industries.

Benefits gained from the ColVisTec UV-VIS inline technology are:

* Continuous, nonstop determination of API concentration

* Detection of the distribution of API in molten polymer

* Residence time determination, with the answer available within 10 minutes

* Rapid validation of screw configuration

* Real-time monitoring of feed rate

Early adopters of this new technology have included leading pharmaceutical companies and academic institutions with a strong focus on pharmacology. ColVisTec works with extruder manufacturers, in particular Leistritz for the pharma sector, to give pharma industry customers an opportunity to try out UV-VIS based spectroscopy while the tests are run on Leistritz extruders.

Advantages to pharmaceutical sector

ColVisTec claims that its innovative inline technology gives the end user the benefit of significantly reduced time requirements for the development cycle, leading to a shorter time to market. Other benefits include high mixing efficiency, leading to less waste and greater output, and immediate detection of feeder problems or other incidents causing the API to deviate from the specified standard.

ColVisTec is a technology provider in the field of optical spectral photometry, UV-VIS spectrophotometry, colorimetric and optics. The company generates improved efficiency and value through early detection and prevention of errors via process monitoring and continuous quality control. Different probes provide solutions for a range of applications, including transparent and opaque materials. Particular areas of expertise are applications for: polymers (extrusion application), powder (powder coatings and other powder form materials), mixing processes, paste material (cosmetics, paints etc.), liquid coatings and paints, inks, pharmaceuticals (hot melt extrusion, wet granulation), food, beverages and other liquid materials.

Jan H. Johnsen is CEO of Colvistec.

For more information, visit www.scientistlive.com/eurolab

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