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METHOD FOR THE DETECTION OF MICROORGANISMS IN PHARMACEUTICAL PRODUCTS

机译:药品中微生物的检测方法

摘要

The present invention discloses a method for the detection and identification of living microbial contaminant cells in pharmaceutical products, pharmaceutical production environments, cosmetics and food. The method of the invention is based on the selective amplification by quantitative PCR of specific target cDNA sequences, in particular sequences encoding ribosomal RNA of the microbial contaminant to be detected.The invention also provides for a test kit for the detection and identification of living microbial contaminant cells in pharmaceutical products, pharmaceutical production environments, cosmetics and food comprising primers and probes specific for a ribosomal RNA target gene of the microbial contaminant.
机译:本发明公开了一种用于检测和鉴定药物产品,药物生产环境,化妆品和食品中的微生物污染细胞的方法。本发明的方法基于通过定量PCR选择性扩增特定的靶cDNA序列,特别是待检测微生物污染物的编码核糖体RNA的序列。本发明还提供了用于检测和鉴定活微生物的测试试剂盒。药物产品,药物生产环境,化妆品和食品中的污染物细胞,其包含对微生物污染物的核糖体RNA靶基因具有特异性的引物和探针。

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