粉末注射剤の各種溶解法における微生物汚染の実験的研究

概要

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The microbial contamination of sterile injectable solid preparations was investigated. In place of sterile injectable solid preparation, a sterile medium was reconstituted with the diluent, using the following four methods; (A) a needle and a syringe, (B) a double-ended needle, (C) a connected tube, and (D) a newly designed closed-system sterile reconstitution kit. This experiment was done in five separate places in the author's hospital. Staphylococcus aureus suspension was inoculated on a small surface area of the syringe plunger. The conditions of plunger were both dry and wet, and those of syringe type were both a reusable glass and two kinds of disposable plastic. A liquid medium was injected into the syringe before and after the intentional microbial challenge. As a result, of the 50 test vials in each method, the number contaminated was 12 in method (A), 1 in (B), 2 in (C), and 0 in (D). The isolated bacteria were identified Staphylococcus species, Staphylococcus aureus, and Micrococcus species. All reusable glass syringes instilled after microbial challenge were contaminated, but no contamination was found in disposable plastic syringes. This may be resulted from structural difference.
日本医療薬学会の論文
1989-10-20