アンプルカット時に混入する不溶性微粒子に関する研究

-ガラス製品とプラスチック製品との比較-

抄録

The hazardous effects of insoluble microparticles generated in injections has been a matter of concern for some time and recently,plastic ampoules have been developed for injection containers as a means of decreasing particle contamination on opening ampoules.To our knowledge,as no studies have been done on insoluble microparticle contamination arising when plastic ampoules are opened,we performed the present study to compare particle contamination from glass ampoules on opening with that from plastic ones and assessed the contribution of the ampoule material to particle generation.We observed that insoluble microparticle contamination from plastic ampoules was significantly lower than that from glass ampoules and therefore conclude that the amount of insoluble particles appears to be relatedtothematerialoftheampouleand recommend using plastic ampoules to prevent microparticle contamination.