Improved direct epifluorescent filter technique for rapid bioburden control in intravenous solutions.

J M Esteban, M L Diaz, F Soriano, E Marin
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Abstract

Epifluorescence microscopy of the microcolonies obtained after filtration of a deliberately contaminated intravenous solution, was used for the rapid detection and enumeration of the bacteria. The technique is adequate for the test of low volume solution (with low contamination). Also it allows one to detect a single colony forming unit (c.f.u.)/mL, with great correlation between fluorescence counts and pour plate colony counts; the morphology of microcolonies is typical for most of the microorganisms and it allows a primoidentification (for a trained analyst).

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改进的直接荧光过滤技术用于静脉溶液的生物负荷快速控制。
对故意污染的静脉溶液过滤后获得的微菌落进行荧光显微镜观察,用于快速检测和枚举细菌。该技术适用于小体积溶液(低污染)的测试。它还允许检测单个菌落形成单位(c.f.u)/mL,荧光计数和倾注板菌落计数之间有很大的相关性;微菌落的形态对大多数微生物来说是典型的,它允许初步鉴定(对于训练有素的分析人员)。
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Evaluating out-of-specification laboratory results. Simplifying and improving process validation. Depyrogenation of pharmaceutical solutions using submicron and ultrafilters. USP perspectives on particle contamination of injectable products. Moisture measurement: a new method for monitoring freeze-drying cycles.
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