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Evaluation of Particle Techniques for the Characterization of Subvisible Particles from Elastomeric Closure Components

Manuscript published in J. Pharm Sci May 2020 issue, Authors: John Rech, Amber Fradkin, Aaron Krueger, Crystal Kraft, and Diane Paskiet, Acknowledgements: Allison Radwick
In this article, optimum sample preparation and analytical techniques were established to evaluate sub-micron particle and SbVP loads from elastomeric closure components. Additionally, the impact of stopper siliconization and polysorbate 80 interaction on the degree of SbVP in the final drug product was assessed.

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