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Evaluation of Glass Delamination Risk in Pharmaceutical 10 mL/10R Vials

Dominique Ditter1, Alejandra Nieto2, Hanns-Christian Mahler3

  • 1Late-Stage Pharmaceutical and Processing Development, Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel 4070, Switzerland; Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, Basel 4056, Switzerland; Division of Pharmaceutical Technology, Goethe University of Frankfurt, Max-von-Laue-Str. 9, Frankfurt am Main 60323, Germany.

Journal of Pharmaceutical Sciences
|October 10, 2017
PubMed

Keywords:
formulationglassinteractionmicroparticlesparticle sizeprotein formulation

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