抗がん剤による職業的曝露回避のためのバイアル包装の耐破損性能評価－オンコテイン™の耐破損性について－

抄録

Onco-Tain^TM Vial, which was developed to prevent occupational exposures to hazardous drugs such as antineoplastic drugs, is a vial preparation equipped with sheathings (a PVC reinforced base and a shrink wrapping of a protective PET sleeve on the vial). The shatter-resistance of the Onco-Tain™ vial was evaluated with a free fall test. Four types (9 strengths in total) of Onco-Tain™ vials, which contain antineoplastic agents and are available worldwide, were used in the test. Vials with the PVC bases and PET sleeves removed from the Onco-Tain™ vial were used as the control. Mimicking the fall of vials in the medical setting, the falling heights were set at 70, 135 and 180 cm, and the breakage ratios of vials and the scattering area of contents were measured.
In the control group (Non-OT group), 3.5, 9.4 and 8.9 percent of vials were broken at the heights of 70, 135 and 180 cm, respectively, and the scattering of contents was observed in all broken vials. The breakage ratios of vials in the Onco-Tain™ vial group (OT group) were statistically significantly lower (0.0 and 2.4%) at the heights of 70 and 135 cm, and tended to be lower (3.3%) at the height of 180 cm. No leakage was observed in vials broken in the OT group. The significant improvement of shatter-resistance of vials was confirmed by applying the protection sleeves to the surface of the vials. By applying these concepts in the future, a decrease of occupational exposures to hazardous drugs caused by the breakage of containers is expected.