Source Apportionment and Quantification of Liquid and Headspace Leaks from Closed System Transfer Devices via SIFT-MS
Drs Amos Doepke and Robert Streicher, CDC/NIOSH/HELD/CBMB, Cincinnati, USA
A system to differentiate and quantify liquid and headspace leaks from closed system transfer devices (CSTDs) is presented. CSTDs were designed to reduce or eliminate needle stick and hazardous drug (HD) exposure risk when compounding and administering HDs. CSTDs may leak liquid, headspace, or a mixture of the two sources. The amount of HD contained in liquid and headspace leaks may be substantially different. Use of a test solution containing VOC marker compounds present in different ratios in the headspace and liquid enables source apportionment of leaked material. Calibration data and the methods to determine the origin (liquid or headspace) and magnitude of leaks from CSTDs are presented. A limit of detection of 25 µL of headspace and 0.25 µL of liquid and a propagated uncertainty for mixed liquid and headspace leak calculations are shown for this method.
Dr. Doepke is a chemist and Senior Service Fellow at the National Institute for Occupational Safety and Health (NIOSH). Dr. Doepke earned his Ph.D. in analytical chemistry from the University of Cincinnati. His work at NIOSH includes; analytical method development and atmosphere generation. Dr. Streicher earned his Ph.D. in Organic Chemistry from the University of Cincinnati. He is a Team Leader in the Chemical and Biological Monitoring Branch of the NIOSH. He has worked at NIOSH for 32 years in the area of sampling and analytical method development.
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