Application Note ReView: Analysing Volume Leaks in Closed System Transfer Devices (CSTD) using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS)
Hazardous drugs delivered by the parenteral route pose a significant risk to health-workers during both drug reconstitution and administration. To mitigate this risk, medical devices referred to as closed system transfer devices (CSTDs) have been developed to contain hazardous drug materials and protect health-workers from accidental exposure. As such, volume leaks from CSTDs are potentially extremely dangerous and so this edition of Application Note ReView takes a look back at AS238 – Application of Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) to the Containment Performance of Closed System Transfer Devices (CSTDs).
Using propylene glycol methyl ether (PGME) as a surrogate, it has been shown that SIFT-MS can detect sub-microlitre volume leaks from these devices, following the testing protocols developed by NIOSH.
Depending on the concentration used, the limits of detection for this technique suggest that leaks as small as 10 nanolitres should detected, significantly lower than current techniques such as FTIR.
Additionally, the real-time capabilities of SIFT-MS gives it excellent temporal response, sensitivity and selectivity of detection, covering the ideal requirements of detection in a single instrument.
The operation of the SIFT-MS is also straightforward, when compared to TD-GC-MS – another suggested technique for this type of analysis, which can achieve good sensitivity but is not capable of real-time detection.
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