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Foreign Particle Characterisation of Parenteral Drug Product Solutions Using Scanning Electron Spectroscopy Combined with Energy Dispersive X-Ray Spectroscopy

Markus Keller², Kai Lischka¹, Tobias Posset¹

¹ Roche Diagnostics GmbH, Mannheim, Germany
² Fraunhofer Institut Produktionstechnik und Automatisierung IPA, Stuttgart, Germany

Corresponding author: Dr. Tobias Posset, Sandhofer Str. 116, 68305 Mannheim (Germany), e-mail: tobias.posset@roche.com

This paper shows that it is possible to identify both extrinsic and intrinsic particles of organic, inorganic and/or organometallic composition in parenteral drug solutions by means of SEM-EDS spectroscopy using the PSEM instrument from Aspex. To develop specific selection rules, product-specific particles were synthesised and characterised by means of SEMEDS. The particles were separated from the drug solutions by means of filtration (0.45 mm) and characterised with respect to their elemental composition. Using this procedure with our parenteral drug solutions it was possible to rule out intrinsic particles as the source of the particulate contamination. In addition to this new procedure for the examination of particles on a filter, we also used a method known from microscopy for the isolation of individual particles in solution. Using a tungsten needle, visible particles were isolated under the microscope and subsequently characterised by SEM and EDX spectroscopy. It has been shown that the smallest particles visible on visual inspection (85 – 100 mm) were cellulose fibres that were incorporated in the course of the production process.

Key words EDX • Parenteral solutions • Particles: extrinsic, subvisible, visible • Product-specific selection rules • SEM-EDS • Single particle analysis, isolation