Glass Particle Contamination in Single Dose Ampules upon Opening

Chae, Jung Hae; Kim, Won Oak; Kil, Hae Keum; Kim, Jong Rae

Abstract

Single dose glass ampules have been developed for ease of administration, accuracy of measurement of dosage, sterility and use in prepackaged kits. Glass particle contamination of the contents of single dose glass ampules can occur upon opening. In our study, we determined whether different ampule size, different aspiration techniques or different methods of ampule opening had any effect on glass particle contamination. Different ampule sizes (1, 2, 20 ml), different aspiration techniques (19G, 22G needle) and different methods of ampule opening (one point ampule, cutting with circular etching, cutting with one plane etching) were evaluated. There was no signifcant difference in the number of particles aspirated by any given aspiration technique, ampule size and method of ampule opening. But intravenous glass particle administration is associated with patholagic responses, so the use of a filter needle, and in-line filter devices and a low pressure infusion system is advised.