Pressure Compatibility Test of Closed System Drug Transfer Devices for 71 Anticancer Drugs

Ishimaru, Hiromasa; Tsuda, Yasumasa; Kage, Hidenori; Kawano, Tomoaki; Takayama, Shinji; Morimoto, Yoshihito; Goto, Kazumi; Watanabe, Kazuhiro

doi:10.1248/yakushi.20-00188

Cited by 3 publications

(2 citation statements)

References 16 publications

(12 reference statements)

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“…Hydrogen gas was used as a leak agent as a measure of the gas-tight seal of CSTDs by Besheer et al [12]. Pressure compatibility by Ishimaru et al showed that pressure testing could reveal headspace leaks [20,21].…”

Section: Introductionmentioning

confidence: 99%

Source apportionment and quantification of liquid and headspace leaks from closed system drug-transfer devices via Selected Ion Flow Tube Mass Spectrometry (SIFT-MS)

Doepke

Streicher

2021

PLoS ONE

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A system to differentiate and quantify liquid and headspace vapor leaks from closed system drug-transfer devices (CSTDs) is presented. CSTDs are designed to reduce or eliminate hazardous drug (HD) exposure risk when compounding and administering HDs. CSTDs may leak liquid, headspace, or a mixture of the two. The amount of HD contained in liquid and headspace leaks may be substantially different. Use of a test solution containing two VOCs with differences in ratios of VOC concentrations in the headspace and liquid enables source apportionment of leaked material. SIFT-MS was used to detect VOCs from liquid and headspace leaks in the vapor phase. Included in this report is a novel method to determine the origin and magnitude of leaks from CSTDs. A limit of leak detection of 24 μL of headspace vapor and 0.14 μL of test liquid were found using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS).

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Section: Introductionmentioning

confidence: 99%