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High concentration drug products in pre-filled syringes: clogging issue

  • In: Poster Presentation
  • At: Stockholm (Sweden) (2017)
  • Type: Poster
  • Poster code: P-C-011-Monday
  • By: DE BARDI, Monica (F. Hoffmann-La Roche Ltd, Late Stage Pharmaceutical and Process Development, Basel, Switzerland)
  • Co-author(s): Monica De Bardi: Late Stage Pharmaceutical and Process Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland;Department of Physics, University of Basel, Basel, Switzerland
    Mathieu Rigollet: Device Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
    Frank Bamberg: Device Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
    Robert Müller: Late Stage Pharmaceutical and Process Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
    Thomas A. Jung: Department of Physics, University of Basel, Basel, Switzerland
    Kewei Yang: Late Stage Pharmaceutical and Process Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Abstract:

    Backgrounds

    In pre-filled syringes (PFS) filled with high concentration drug products a progressive gelation of the liquid in the needle might occur, leading to a blockage and a consequent incorrect administration of the drug. Under certain storage conditions water vapor might diffuse to the environment through the rubber of the needle shield..

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Last update 28 September 2023

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