药学实践杂志
藥學實踐雜誌
약학실천잡지
THE JOURNAL OF PHARMACEUTICAL PRACTICE
2001年
2期
83-85
,共3页
吴晓放%黄福裕%冯常泗%潘留华
吳曉放%黃福裕%馮常泗%潘留華
오효방%황복유%풍상사%반류화
管路%处理效果%验证%清洁规程
管路%處理效果%驗證%清潔規程
관로%처리효과%험증%청길규정
pipe%cleaning effect%test and verify%clean rules
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。
目的:驗證大輸液生產的管路處理效果。方法:檢測管路經過處理後最終遲洗水中的殘留物和微生物指標。結果:大輸液生產的管路按照規定的清洗程序清洗後,最終遲洗水的指標如下:管路進齣水口的電導率基本一緻,菌落數<50CFU/ml,細菌內毒數<0.25EU/ml。結論:濟南市山泉製藥廠大輸液生產車間製定的容器設備管道的清洗規程能夠達到預期的處理效果。
목적:험증대수액생산적관로처리효과。방법:검측관로경과처리후최종충세수중적잔류물화미생물지표。결과:대수액생산적관로안조규정적청세정서청세후,최종충세수적지표여하:관로진출수구적전도솔기본일치,균락수<50CFU/ml,세균내독수<0.25EU/ml。결론:제남시산천제약엄대수액생산차간제정적용기설비관도적청세규정능구체도예기적처리효과。
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,Jinan,The desired cleaning effect of the pipe of infusion solution can be achieved.