Two methods of single-dose ampule opening and their influence upon glass particulate contamination.
Contamination of glass ampules by glass fragments can occur following ampule opening. The intravenous administration of these glass fragments in animal experiments has resulted in insult to the brain, pulmonary, hepatic, renal, and splenic systems of these animals. Thus, it is of clinical importance to determine quantitatively the extent of glass particulate contamination by examining the different methods of glass ampule opening. Twenty, 2-mL single-dose glass ampules were examined for glass fragments following opening. Ten of the ampules were snapped open by hand while 10 were snapped open with the use of a commercial ampule opener. The contents of the ampules were aspirated into a 5-mL glass syringe, attached to an 18-gauge nonfilter needle. The contents of the syringe were filtered, then examined for glass fragments under a microscope. The size and number of glass particles were recorded using a calibrated ocular micrometer. Analysis of variance for repeated measures and Duncan's test showed no significant difference between the two groups. Thus, no significant difference existed in the number and size of glass particles aspirated when comparing these two ampule opening methods.
Giambrone
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AJ
D004340:Drug Contamination / Q000517:prevention & control / Q000706:statistics & numerical data*; D004349:Drug Packaging / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards; D005069:Evaluation Studies as Topic; D005898:Glass; D006801:Humans