アンプルカット時に混入する異物について : 光学顕微鏡および電子顕微鏡の所見

概要

論文の詳細を見る
Glass particles in parenteral solutions, which may arise in the ampoule-cutting process, were counted. 5-ml ampoules of various parenteral solutions were cut and the solutions were centrifugalized for 30 minutes at a speed of 3,000 rpm at room temperature. The bottom layers of centrifugalized solutions were rinsed 3 times with distilled water; then examined by optical and electron microscopes. The number of glass particles over 5 μ in size in the solutions, counted with Luzex 450 particle analyzer, was greatly varied with methods : 1,353 with all round cutting, with ampoule-cutter, 2,439 with half round cutting, 586 with all round cutting followed by wiping with ethanol cotton swab, 531 with cutting with glass cutter. The dropping time of the glass particles through parenteral solutions was also measured. Further, the possibility of microorganisms carried into parenteral solutions by the glass particles was examined by means of BTB culture and blood agar. No microorganisms were found. The results of the above study suggest that contamination with microorganisms can be avoided by using special ampoule-cutting devices.
日本医療薬学会の論文