We investigated the influence of the ampule package in reducing the risk of“one-point cut”glass injection ampules breaking when dropped.Four test products were subjected to horizontal and vertical drop tests from heights of 60 and 85 cm according to JIS Z 0202 in the Japanese Industrial Standards.A novel square ampule cover that was sufficiently larger than the glass ampule and sealed with a polypropylene film markedly reduced the breakage risk (Tukey’s HSD test : P< 0.001),and there was no significant correlation between the height from which ampules were dropped and breakage (analysis of variance : P=0.069).
We concluded that the novel ampule cover was useful for the packaging of injectable drugs used in clinical practice as it not only reduces the risk of glass ampules breaking but also prevents scattering of the solutions contained in them.
