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生物实验室里深圳层流罩洁净度测试

2021-08-18

近些年各种各样缘故导致的药物安全事故频繁产生,给我国和社会发展产生了极大的损害,在社会发展上造成了许多不良影响。为保证药物的安全性,我国颁布:了有关要求以标准生产制造口。在生物医药全过程中分装做为制成品与外部触碰的最终一道阶段,其工作环境的深圳层流罩无菌检测化可以直接对药物的产品质量起着根本性功效。.分装环境的无菌检测是确保分装商品做到无菌检测生产制造规定的一项关键步骤,而分装间内实施的各种各样杀菌揩施是环境无菌检测的关键确保。本试验对于分装间内实施的3种杀菌对策的实际效果开展评定,以明确这种揩施的实行是不是能做到有关要求,为无菌检测生产制造出示强有力确保。

1YUANCAILIAOYUFANGSHI 

1.1YUANCAILIAOSHIYANYUANCAILIAO:YANSHUI、SHINEIJIAQUAN、GAOMENGSUANJIARONGYE、84XIAODUYE、YICHUN。SHIYANQICAI:FUCHENKELIJIANCEYI、HENGWENPEIYANGXIANG、PINGMIN、MIANQIU、KAIFANGSHIPEN。

1.2FANGSHI 

1.2.1SHINEIJIAQUANSHAJUN:

(1)XIAODUFANGFA:JIANGFENZHUANGSHENGCHANCHEJIANNEIJUNZHIFENCHENG10GESHAJUNJIYAODIAN,MEIYIGEJIYAODIANFANGYIGEKAIFANGSHIPEN,GUANDIAOZIRANTONGFENGHOUZAIPENLIJIAREN1:3DEGAOMENGSUANJIARONGYEHESHINEIJIAQUAN,SUIHOUFENGBISHISHENGCHANCHEJIANKAIZHANSHAJUN;SHAJUNSHIJIANGEZICAOZONGZAI6XIAOSHIHE12h,MIBISHIZUODAOTEDINGSHIJIANHOUKAIZHANZIRANTONGFENG,SHAJUNWANBI。

(2)JIANCEFANGSHI :SHINEIJIAQUANSHAJUNHOU,ZAIFENZHUANGSHENGCHANCHEJIANNEIYUNCHENG.FANGZHI10GENIUROUGAODANBAIDONGPEIYANGYEPINGMIN,SUIHOUKAIFANGSHIZHIFANG30min。JIANGPINGMINFANGJINHENGWENPEIYANGXIANGNEISUZAO24XIAOSHI,GUANCHABINGJILUPINGMINNEIXIJUNJUNLUOSHU,FANFU3CI。

深圳层流罩

1.2.2BUXIUGANGCHUANDICHUANGZIWAIXIANMIEJUN:

(1)MIEJUNFANGFA:WAIBUCHUANSONGWUJIANFANGRENBUXIUGANGCHUANDICHUANGHOUGUANDIAOMENCHUANG,ZIWAIXIANMIEJUNDENGSHAJUN30minHOUKECHUANCHENGWUJUNCHEJIANNEI。

(2)JIANCEFANGSHI :JIANGYOUWAIBUDAKAIGUODEBUXIUGANGCHUANDICHUANGGUANDIAOHOU,ZIWAIXIANMIEJUNDENGGEZISHAJUN.15minHE30min;;ZAIZIWAIXIANMIEJUNDENGSHAJUNHOUDEBUXIUGANGCHUANDICHUANGNEIKAIFANGSHIZHIFANGNIUROUGAODANBAIDONGPEIYANGYEPINGI30min,SUIHOUBAPINGMINFANGRENHENGWENPEIYANGXIANGNEISUZAO24XIAOSHI,GUANCHABINGJILUPINGMINNEIXIJUNJUNLUOSHU,GEFANFU3CI。

1.2.3QITISHENZHENCENGLIUZHAO:

(1)CAOZUOFANGFA:ZAIJINDAOWUJUNCHEJIAN.GONGZUOZHONGQIAN,GONGZUOZHONGDIQUDEQITISHENZHENCENGLIUZHAOYAOTIZAO1hDAKAIKAIZHANKONGQIGUOLV。

(2)JIANCEFANGSHI :JIANYANQIANGEZIJIANGKONGQI.LIUZHAODAKAI30minHE1h,YONGFUCHENKELIJIANCEYIDUIQITICENGLIUZHAOXIADE5CHUFUCHENKELISHUKAIZHANJIANYAN,GEFANFU3CI。

2JIEGUOYUPOUXI

2.1SHINEIJIAQUANSHAJUNHOUJUNTISHUJIANYANJIEGUOSHINEIJIAQUANSHAJUN6XIAOSHIHOURENGJIGEQUYANGDIANNENGGOUJIANYANDAOCHAOBIAOZHUNDECHENJIANGJUN,BIAOMINGZAISHAJUNSHIJIANBUGOUDEZHUANGKUANGXIABUKEYIZUODAOLIXIANGHUASHAJUNSHIJIXIAOGUO,YINERSHINEIJIAQUANSHAJUNYAOANGUIFANKAIZHAN12hSHAJUN。

2.2BUXIUGANGCHUANDICHUANGZIWAIXIANMIEJUNSHIJIXIAOGUO.NENGGOUKANDECHU30minZIWAIXIANMIEJUNHOUBUXIUGANGCHUANDICHUANGNEIMEIYOUJIANYANCHUCHENJIANGJUN,ERZIWAIXIANMIEJUN15minZEYOUJIAODUODECHENJIANGJUN。YIJUCAILIAOXIANSHIXINXI,ZIWAIXIANMIEJUNNENGGOUBUDUAN5hQUEBAOWUJUNJIANCE,YINCI ZAISHAJUN30minHOUNENGGOUZAIWUJUNCHEJIANNEIQUXIAWUJIANQIEBUKONGQIDEWURAN。

2.3QITICENGLIUZHAOXIAFUCHENKELISHUJIANYANJIEGUOYIJUYOUGUANGUIFANQIANJIDIQU0.5μmFUCHENKELISHUBUKECHAOCHU3500,ER5μmFUCHENKELIBUKEYICHUXIAN。KONGQIZHONGDEWEISHENGWUJUNZHONGDADUOSHUZHANFUZAI≥0.5μmCHENTUKELISHANG,JUEDABUFENXIJUNZHIJING--BANWEI0.5~5μm,ZAIKONGQIZHONGJIBENSHANGSUOYOU.NIANFUYUFUCHENSHANG,CHANSHENG5~10μmLIDUDEQIANZAIXINGKELIERPIAOFUZHE。

ZAISHENZHENCENGLIUZHAODAKAI30minDEZHUANGKUANGXIA,QIANJIDIQUNEIFUCHENKELIBUKEYICHEDIPAICHULAI,DABUSHANGGUIDINGDEGUIFAN;ZAICENGLIUZHAODAKAI1hHOUQIANJIDIQUNEIFUCHENKELIDEPAICHULAIFUHEGUIDING。



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行业新闻

生物实验室里深圳层流罩洁净度测试

近些年各种各样缘故导致的药物安全事故频繁产生,给我国和社会发展产生了极大的损害,在社会发展上造成了许多不良影响。为保证药物的安全性,我国颁布:了有关要求以标准生产制造口。在生物医药全过程中分装做为制成品与外部触碰的最终一道阶段,其工作环境的深圳层流罩无菌检测化可以直接对药物的产品质量起着根本性功效。.分装环境的无菌检测是确保分装商品做到无菌检测生产制造规定的一项关键步骤,而分装间内实施的各种各样杀菌揩施是环境无菌检测的关键确保。本试验对于分装间内实施的3种杀菌对策的实际效果开展评定,以明确这种揩施的实行是不是能做到有关要求,为无菌检测生产制造出示强有力确保。

1YUANCAILIAOYUFANGSHI 

1.1YUANCAILIAOSHIYANYUANCAILIAO:YANSHUI、SHINEIJIAQUAN、GAOMENGSUANJIARONGYE、84XIAODUYE、YICHUN。SHIYANQICAI:FUCHENKELIJIANCEYI、HENGWENPEIYANGXIANG、PINGMIN、MIANQIU、KAIFANGSHIPEN。

1.2FANGSHI 

1.2.1SHINEIJIAQUANSHAJUN:

(1)XIAODUFANGFA:JIANGFENZHUANGSHENGCHANCHEJIANNEIJUNZHIFENCHENG10GESHAJUNJIYAODIAN,MEIYIGEJIYAODIANFANGYIGEKAIFANGSHIPEN,GUANDIAOZIRANTONGFENGHOUZAIPENLIJIAREN1:3DEGAOMENGSUANJIARONGYEHESHINEIJIAQUAN,SUIHOUFENGBISHISHENGCHANCHEJIANKAIZHANSHAJUN;SHAJUNSHIJIANGEZICAOZONGZAI6XIAOSHIHE12h,MIBISHIZUODAOTEDINGSHIJIANHOUKAIZHANZIRANTONGFENG,SHAJUNWANBI。

(2)JIANCEFANGSHI :SHINEIJIAQUANSHAJUNHOU,ZAIFENZHUANGSHENGCHANCHEJIANNEIYUNCHENG.FANGZHI10GENIUROUGAODANBAIDONGPEIYANGYEPINGMIN,SUIHOUKAIFANGSHIZHIFANG30min。JIANGPINGMINFANGJINHENGWENPEIYANGXIANGNEISUZAO24XIAOSHI,GUANCHABINGJILUPINGMINNEIXIJUNJUNLUOSHU,FANFU3CI。

深圳层流罩

1.2.2BUXIUGANGCHUANDICHUANGZIWAIXIANMIEJUN:

(1)MIEJUNFANGFA:WAIBUCHUANSONGWUJIANFANGRENBUXIUGANGCHUANDICHUANGHOUGUANDIAOMENCHUANG,ZIWAIXIANMIEJUNDENGSHAJUN30minHOUKECHUANCHENGWUJUNCHEJIANNEI。

(2)JIANCEFANGSHI :JIANGYOUWAIBUDAKAIGUODEBUXIUGANGCHUANDICHUANGGUANDIAOHOU,ZIWAIXIANMIEJUNDENGGEZISHAJUN.15minHE30min;;ZAIZIWAIXIANMIEJUNDENGSHAJUNHOUDEBUXIUGANGCHUANDICHUANGNEIKAIFANGSHIZHIFANGNIUROUGAODANBAIDONGPEIYANGYEPINGI30min,SUIHOUBAPINGMINFANGRENHENGWENPEIYANGXIANGNEISUZAO24XIAOSHI,GUANCHABINGJILUPINGMINNEIXIJUNJUNLUOSHU,GEFANFU3CI。

1.2.3QITISHENZHENCENGLIUZHAO:

(1)CAOZUOFANGFA:ZAIJINDAOWUJUNCHEJIAN.GONGZUOZHONGQIAN,GONGZUOZHONGDIQUDEQITISHENZHENCENGLIUZHAOYAOTIZAO1hDAKAIKAIZHANKONGQIGUOLV。

(2)JIANCEFANGSHI :JIANYANQIANGEZIJIANGKONGQI.LIUZHAODAKAI30minHE1h,YONGFUCHENKELIJIANCEYIDUIQITICENGLIUZHAOXIADE5CHUFUCHENKELISHUKAIZHANJIANYAN,GEFANFU3CI。

2JIEGUOYUPOUXI

2.1SHINEIJIAQUANSHAJUNHOUJUNTISHUJIANYANJIEGUOSHINEIJIAQUANSHAJUN6XIAOSHIHOURENGJIGEQUYANGDIANNENGGOUJIANYANDAOCHAOBIAOZHUNDECHENJIANGJUN,BIAOMINGZAISHAJUNSHIJIANBUGOUDEZHUANGKUANGXIABUKEYIZUODAOLIXIANGHUASHAJUNSHIJIXIAOGUO,YINERSHINEIJIAQUANSHAJUNYAOANGUIFANKAIZHAN12hSHAJUN。

2.2BUXIUGANGCHUANDICHUANGZIWAIXIANMIEJUNSHIJIXIAOGUO.NENGGOUKANDECHU30minZIWAIXIANMIEJUNHOUBUXIUGANGCHUANDICHUANGNEIMEIYOUJIANYANCHUCHENJIANGJUN,ERZIWAIXIANMIEJUN15minZEYOUJIAODUODECHENJIANGJUN。YIJUCAILIAOXIANSHIXINXI,ZIWAIXIANMIEJUNNENGGOUBUDUAN5hQUEBAOWUJUNJIANCE,YINCI ZAISHAJUN30minHOUNENGGOUZAIWUJUNCHEJIANNEIQUXIAWUJIANQIEBUKONGQIDEWURAN。

2.3QITICENGLIUZHAOXIAFUCHENKELISHUJIANYANJIEGUOYIJUYOUGUANGUIFANQIANJIDIQU0.5μmFUCHENKELISHUBUKECHAOCHU3500,ER5μmFUCHENKELIBUKEYICHUXIAN。KONGQIZHONGDEWEISHENGWUJUNZHONGDADUOSHUZHANFUZAI≥0.5μmCHENTUKELISHANG,JUEDABUFENXIJUNZHIJING--BANWEI0.5~5μm,ZAIKONGQIZHONGJIBENSHANGSUOYOU.NIANFUYUFUCHENSHANG,CHANSHENG5~10μmLIDUDEQIANZAIXINGKELIERPIAOFUZHE。

ZAISHENZHENCENGLIUZHAODAKAI30minDEZHUANGKUANGXIA,QIANJIDIQUNEIFUCHENKELIBUKEYICHEDIPAICHULAI,DABUSHANGGUIDINGDEGUIFAN;ZAICENGLIUZHAODAKAI1hHOUQIANJIDIQUNEIFUCHENKELIDEPAICHULAIFUHEGUIDING。



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