2019 年 34 巻 4 号 p. 204-211
In facilities where high potent pharmaceutical compounds are treated, it is important to take measures for the containment of compound particles, in order to prevent product contamination, worker’s health damage and environmental pollution. The ISPE SMEPAC guideline is generally known as the standard measure for evaluating containment performance, but in those procedures, it often takes a few days or more until the analytical results are obtained. In this study, we ran some trials to develop a technique for on-site measuring that can monitor the particle concentration of pharmaceutical compound dust in the air in real-time. We prepared novel fluorescent surrogate particles and investigated the detective performance of the system composed of those same particles and their measurement equipment. We also evaluated the applicability of the system for containment facility which would be practically-used on site. It has been concluded that this measuring technique could be applied to monitoring the containment performance of high potent pharmaceutical compounds on-site in real-time.