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分装放射性药物的无菌检测。

The sterility testing of dispensed radiopharmaceuticals.

作者信息

Brown S, Baker M H

出版信息

Nucl Med Commun. 1986 May;7(5):327-36. doi: 10.1097/00006231-198605000-00002.

Abstract

The benefits of retrospective sterility tests on radiopharmaceuticals, were assessed by following the survival of bacteria in non-radioactive and radioactive kits and generator eluate over a period of 5 days. The response of bacteria inoculated into non-radioactive materials ranged through death, survival and growth. The response of bacteria inoculated into radioactive materials was either death or survival. The value of retrospective sterility testing is doubtful and an improved test method is suggested.

摘要

通过跟踪非放射性和放射性试剂盒及发生器洗脱液中细菌在5天时间内的存活情况,评估了放射性药物回顾性无菌试验的益处。接种到非放射性材料中的细菌反应包括死亡、存活和生长。接种到放射性材料中的细菌反应则为死亡或存活。回顾性无菌试验的价值值得怀疑,并提出了一种改进的试验方法。

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