大容量注射剂用原材料的微生物污染
Microbiological contamination of raw materials for large-volume parenterals.
作者信息
Baggerman C, Kannegieter L M
出版信息
Appl Environ Microbiol. 1984 Sep;48(3):662-4. doi: 10.1128/aem.48.3.662-664.1984.
Abstract
A wide range of raw materials used for the production of large-volume parenterals were tested for their content of bacteria, molds, yeasts, and endotoxins. All raw materials were relatively free of microorganisms, although some mannitol samples contained relatively high amounts of endotoxin. The low endotoxin content of the other raw materials did not require the use of depth filters to remove endotoxins to prepare pyrogen-free infusion fluids.
摘要
对用于生产大容量注射剂的多种原材料进行了细菌、霉菌、酵母菌和内毒素含量检测。所有原材料相对不含微生物，不过一些甘露醇样品含有相对较高量的内毒素。其他原材料的低内毒素含量在制备无热原输液时无需使用深层过滤器来去除内毒素。
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本文引用的文献
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A comparative study on the performance of asbestos-free depth-filters for removal of pyrogens from infusion fluids.用于去除输液中热原的无石棉深层过滤器性能的比较研究。
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