A Case Study to Address a Gap in the Device-to-Vial Interface Stopper Push-in by Chemo Spikes

PDA Journal of Pharmaceutical Science and Technology
Xia Cathy ZhaoLiang Fang

Abstract

This case study is the first to address the risk, at the device-to-vial interface, of a spike pushing a stopper into a vial. It was performed after healhcare workers at cancer care hospitals complained about the risk of possible exposure to hazardous injectable drugs during the transfer if the spike pushed the stopper into the vial. This case study took a three-step approach to understand the device-to-vial interface and the factors that determine stopper push-in force threshold and spike puncture force, respectively. The results show that the stopper push-in force threshold varies with the spike size, stopper properties, and stopper design, while the spike puncture force is determined by spike design, spike surface lubricity, stopper properties, and stopper design. This case study suggests that to mitigate the risk of stopper push-in, the spike puncture force needs to be significantly lower than the stopper push-in force threshold, measured with a flat-tip test probe having the same outside diameter as typically used spikes. In addition, although some factors that impact stopper push-in force threshold also impact spike puncture force in the same trend, such as stopper material, other factors that impact stopper push-in force ...Continue Reading

Citations

Apr 11, 2020·Pharmaceutical Research·Ahmed BesheerRoman Mathaes
Nov 1, 2020·Journal of Pharmaceutical Sciences·Ahmed BesheerShuxia Zhou

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