Analyse von Silikonschichtdicken bei der Herstellung von Fertigspritzen mit Hilfe von Reflektometriemessungen Markus Lankers rap.ID Particle Systems GmbH, Berlin (Germany) Korrespondenz: Dr. Markus Lankers, rap.ID Particle Systems GmbH, Köenicker Str. 325, 12555 Berlin (Germany), e-mail: markus.lankers@rap-id.com Silicone Oil Layer Thickness Analysis in the Manufacture of Prefilled Syringes using Reflectometry The application of silicone oil to reduce gliding forces is an absolute requirement for the use of syringes. In addition, silicone oil-protein interaction may have adverse impacts on the quality of pharmaceutical products due to the coalescence of aggregates and agent absorption. Siliconization process optimization is therefore essential. A fast silicone layer thickness analysis using reflectometry measurements provides a method to examine the siliconization result. The following paper discusses aspects of method qualification as well as potential areas of application. Key words Fertigspritzen • Reflektometrie• Silikonisierung, Schichtdickenmessung |
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pharmind 2010, Nr. 12, Seite 2148
