For further processing of granules the particle size distribution (PSD) is identified as critical product attribute. The PSD is having a significant impact on the compressibility of granules and consequently on tablet hardness.
Established offline methods for particle size determination (e.g. sieve analysis) provide quality related results only after manufacturing processes. For this reason corrective actions during production are not feasible to ensure product quality.
Using the modified spatial filtering velocimetry method for particle size characterizsation during melt granulation in high shear mixers generates a deeper knowledge of the manufacturing processes and offers the possibility to verify the product quality inline by continuous process monitoring. These approach is called Quality by Design (QbD).
For utilization of the evaluated inline particle size measurement sensor further technical modifications of high shear mixers and the probe as well as the qualification of the sensor is essential. Furthermore, the development of analytical testing methods for correlation purposes with established offline methods are required.
Project Operation:
Prof. Dr. Gerd Kutz (project manager)
Fachbereich 4 – Life Science Technologies
Labor Pharmatechnik
Hochschule Ostwestfalen-Lippe
Georg-Weerth-Straße 20
D-32756 Detmold
Tel.: +49 5231 769-6436
Fax: +49 5231 769-86436
Email: gerd.kutz@hs-owl.de
Stefan Dietrich
Parsum – Gesellschaft für Partikel-, Strömungs- und Umweltmesstechnik mbH
Reichenhainer Straße 34-36
09126 Chemnitz
Tel.: +49 371 2675869-0
Fax: +49 371 2675869-9
Email: stefan.dietrich@parsum.de
Werner Dietzmann
DIOSNA Dierks & Söhne GmbH
Am Tie 23
D-49086 Osnabrück
Tel.: +49 541 33104-810
Fax: +49 541 33104-805
Email: werner.dietzmann@diosna.de
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