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用于维持凝胶过滤柱微生物清洁的清洗程序验证

Validation of washing procedures for maintaining a microbiologically clean gel filtration column.

作者信息

Wen L F, Bohannon T, Crabb A, Mamaril F

出版信息

J Pharm Sci. 1980 Feb;69(2):140-4. doi: 10.1002/jps.2600690205.

DOI:10.1002/jps.2600690205
PMID:6987370
Abstract

Chromatographic gel filtration matrixes used in various separation techniques are subject to microbial contamination. The need for a microbe-free column is critical when preparing materials that require a low or zero microbial count. This report proposes two alternative washing systems: 0.02 N HCl containing 0.81% NaCl, and 0.1 M tromethamine--hydrochloride buffer (pH 7.0) containing 0.81% NaCl and 0.02% thimerosal. These washing systems were validated using a 100 x 2.6-cm column packed with a modified dextran gel slurry previously inoculated with known counts of USP test organisms. After each wash, the column separation characteristics were verified further with appropriate test proteins.

摘要

用于各种分离技术的色谱凝胶过滤基质容易受到微生物污染。在制备要求低微生物计数或零微生物计数的材料时,使用无微生物柱至关重要。本报告提出了两种替代洗涤系统:含0.81%氯化钠的0.02N盐酸,以及含0.81%氯化钠和0.02%硫柳汞的0.1M三羟甲基氨基甲烷 - 盐酸缓冲液(pH 7.0)。使用填充有先前接种已知数量USP试验微生物的改良葡聚糖凝胶浆液的100×2.6厘米柱对这些洗涤系统进行了验证。每次洗涤后,用适当的测试蛋白进一步验证柱的分离特性。

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