医薬品の微生物汚染の動向 : 3年前との比較

概要

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Twenty one pharmaceutical products which had shown a positive reaction of microbial contamination in all of the 5 culture media in the previous sterility test were selected for this test. This paper compares the levels of microbial contamination in the latest test with those in the previous test conducted 3 years before, and also analyzes the tendency of the recent quality control of pharmaceutical products in relation to microbial contamination. In the latest study, total aerobic microbial count of more than 10000/g was observed in 3 of the 21 products, showing the same incidence as in the previous test. Total aerobic microbial count of less than 1,000/g was observed in 15 products, as compared to 10 in the previous test. Coliform organisms were detected in 2 products, compared to 6 in the preceding study.
日本医療薬学会の論文
1977-08-20