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<0.25EU/ml。结论 济南市山泉制药厂大输液生产车间制定的容器设备管道的清洗规程能够达到预期的处理效果。Abstract: 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.
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Key words:
- pipe /
- cleaning effect /
- test and verify /
- clean rules
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