The incubation period in sterility testing.

H Bathgate, D Lazzari, H Cameron, D McKay
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Abstract

Sterility test results gathered over a ten year period have been analysed to determine the effects of the incubation period. Overall there was no difference between the membrane filtration test and direct inoculation in the time required for visible growth of contaminants. Growth occurred earlier if products had no preservative or antimicrobial substances. However use of the membrane filtration method did not significantly enhance the efficiency of detection at seven days incubation. Regardless of the nature of the product or the method of test an unacceptable proportion of contaminants would be missed by limiting incubation to seven days.

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无菌试验中的潜伏期
已经分析了十多年来收集的不育测试结果,以确定潜伏期的影响。总的来说,膜过滤试验和直接接种在污染物可见生长所需的时间上没有差异。如果产品不含防腐剂或抗菌物质,生长就会提前。然而,在7天的培养过程中,膜过滤法并没有显著提高检测效率。无论产品的性质或测试方法如何,如果将孵育期限制在7天内,就会漏掉不可接受比例的污染物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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