Lehermayr, Christian (2025) Current Industry Practices on Closed System Transfer Devices (CSTD) for Drug Products. Journal of pharmaceutical sciences. ISSN XPHS 3684

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.

Item Type:	Article
Date Deposited:	14 Feb 2025 00:45
Last Modified:	14 Feb 2025 00:45
URI:	https://oak.novartis.com/id/eprint/51956