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Updated: May 29, 2025

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
Published on: March 11, 2017
Current industry practices on closed system drug-transfer devices for parenteral drug products
Isabella de Jong1, David Cheng Thiam Tan2, Christian Lehermayr3
1Genentech (A Member of the Roche Group), Pharmaceutical Development, 1 DNA Way, South San Francisco, CA, 94080, USA.
Abstract:
USP<800> and NIOSH provide guidance on the use of Closed System Drug-Transfer Devices for hazardous drug in the healthcare setting. However, CSTDs are used by clinical sites irrespective of drug hazard status. In this paper, previous publications that describe evaluation and CSTD risk assessment strategies are presented. In addition, a pharmaceutical industry survey was performed to describe the current strategies for evaluation of CSTDs and how these devices are managed for clinical studies. Finally, recommendations are proposed to mitigate risks associated with CSTDs. These recommendations incorporate: testing considerations, risk assessments, and communication.
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