116 A Performance Testing Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs

Abstract

Abstract Cytotoxic and other hazardous drugs, whilst potentially therapeutic to patients, pose an occupational exposure hazard to healthcare workers during compounding and administration. However, occupational exposure to these drug compounds can be reduced with the use of closed system transfer devices (CSTDs) designed to prevent the escape of aerosol, liquid or vapour from a hazardous drug vial. In 2015 NIOSH developed a test procedure to assess the containment performance of CSTDs using an isopropanol-water challenge agent and infra-red detection. However, this protocol could not be used to assess devices using air filtration technology. HSE and BSTL therefore developed a modified procedure, using less volatile challenge agents and measurement using thermal desorption (TD) and gas chromatography-mass spectrometry (GC-MS), which could be used to assess all CSTD types. Unlike the NIOSH procedure this approach does not give a ‘real-time’ result but shows significantly greater sensitivity with the challenge agents used; typically being able to detect an airborne concentration of less than 1 part per billion (ppb). Testing carried out using a solution of 2-phenoxyethanol as the challenge agent showed no evidence of release with three of the four CSTDs tested; two barrier devices and one using air filtration. The tests also showed limits of detection to be dependent not only on the analytical procedure but on the effectiveness of the cleaning regime used to decontaminate the exposure chamber between tests.