Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

Journal: Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
PMID:

Abstract

OBJECTIVE: The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system.

Authors

  • Irene Krämer
    Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstraße 1, Mainz, Germany Irene.Kraemer@unimedizin-mainz.de.
  • Matteo Federici
    Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstraße 1, Mainz, Germany.
  • Vanessa Kaiser
    Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstraße 1, Mainz, Germany.
  • Judith Thiesen
    Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstraße 1, Mainz, Germany.