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大输液生产过程中管路处理效果的验证

Test and verify of piping cleaning effect in infusion solution productive process
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摘要 目的 :验证大输液生产的管路处理效果。方法 :检测管路经过处理后最终冲洗水中的残留物和微生物指标。结果 :大输液生产的管路按照规定的清洗程序清洗后 ,最终冲洗水的指标如下 :管路进出水口的电导率基本一致 ,菌落数 <50CFU/ml,细菌内毒数 <0 2 5EU/ml。结论 OBJECTIVE:To test and verify the piping cleaning effect in infusion solution productive process.METHODS:Targets of final washing water of pipe were determined.RESULTS:Targets of final washing water of pipe were that electrical conductivity of entrance of pipe was equal to that of exit of pipe essentially,limitation of bacteria and endotoxin were as follows:<50CFU/ml,<0.25EU/ml.CONCLUSIONS:According to the clean rules laid down by pharmaceutical Factory of Shanquan,the desired cleaning effect of the pipe of infusion solution can be achieved.
出处 《药学实践杂志》 CAS 2001年第2期83-85,共3页 Journal of Pharmaceutical Practice
关键词 管路 处理效果 验证 清洁规程 大输液 pipe cleaning effect test and verify clean rules
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参考文献1

  • 1叶瑛瑛.药品生产验证指南[M].北京:中国医药科技出版社,1996.64-74.

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