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

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Poster
  • 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 4 October 2019

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