GMP对制药厂房的洁净要求
RUJINGUOJIADUISHENGWUZHIYAOXINGYEDEBIAOZHUNYUELAIYUEGUIFANHUAHEYANGEHUA,CONGGMPBIAOZHUNDEBUTONGSHENGJIKEYIKANCHUGUOJIAZHENGZAIYIGMPBIAOZHUNYANGEGUIFANDAOBUTONGXINGYEZHONGQU,JIEXIALAIXIAOBIANDAIDAJIALEJIEXIAGMPDUIZHIYAOCHANGFANGDEJIEJINGYAOQIU!
1、洁净厂房的洁净级别
JIEJINGCHANGFANGDEJIEJINGDUBIAOZHUN,GEGUOYOUGUOJIABIAOZHUN,ZAIDIANZIGONGYE、YUHANGGONGYEZHONGZAOYIYINGYONG,LIRUMEIGUOLIANBANGBIAOZHUN(USFesferalstandard)209B,YINGGUOBIAOZHUN5295(BS5295),WOGUO《JIEJINGCHANGFANGSHEJIGUIFAN》(GB78-84)ZHONGYOUJIEJINGDENGJIDEGUIDING。
《JIEJINGCHANGFANGSHEJIGUIFAN》ZHONGKONGQIJIEJINGDUDENGJI

HUANJINGJIEJINGDUSHIYIHUANJINGZHONGPIAOFUDEWEILIAOSHUHUOSHENGWULIZISHU(XIJUNSHU)LAIGUIDINGDEYIBANRENWEIQIANZHEDUODEHUANJINGXIAHOUZHEYEDUO,DANMEIYOUBIRANDELIANXI。DUIYAOPINSHENGCHANLAISHUO,ZAISHENGCHANHUANJINGZHONGCHULEDUIFEISHENGMINGWURANWU——CHENLIAOYAOJIAYIXIANZHICHULI,HAIBIXUDUIYOUSHENGMINGDEWURANWU——WEISHENGWUZUOCHUGENGYANGEDEXIANZHI。
99BAN《GUIFAN》DUICHANGFANGDEJIEJINGDUJIBIEFENWEI100JI、10000JI、100000JIHE300000JISIGEDENGJI。1000JIDUIZHIYAOYELAISHUOBUSHISHIFENBIYAO,QIZAIDIANZIJIXIEXINGYEJIAOPUBIAN,>300000JIDEHUANJINGJIEJINGDUKONGZHIDUIZHIYAOYEWUTAIDADESHIJIYIYI。SHANGSHUSIJIYIJIBENKEMANZUGELEIYAOPIN、YUANLIAOYAODEGEGONGXUSHENGCHANHUANJINGDEJIEJINGYAOQIU,ERYU SHANGGMPDUICHANGFANGJIEJINGDUBIEHUAFENJIBENXIANGTONG。XINXIUDINGDE《GUIFAN》ZHONGCHANGFANGJIEJINGJIBIEFENLEIRUXIABIAO:
WHO及欧洲共同体GMP厂房洁净度分类表
注释:1、本表来源于欧洲共同体GMP补充指南
2、CENGLIUKONGQIXITONGYINGTIGONGCHUIZHIFANGXIANG030MI/MIAO、SHUIPINGFANGXIANG045MI/MIAOSUDUDEYIKONGQI(ANQILIUXINGSHIJIEJINGKEFENWEICENGLIU、LUANLIU;ANQILIUFANGXIANG,CENGLIUYOUFENWEICHUIZHICENGLIUHESHUIPINGCENGLIU)。
3、WEILEDADAOB、CHEDJI,JINRUSHINEIDEKONGQIYINGYOUYIGEHAODELIUDONGFANGSHIHEJINGGUOSHIDANGDEHEPAGUOLVQIGUOLVCHULI,HUANQICISHUZHISHAO20CI/XIAOSHI。
4、SHANGBIAOZHONGGUIDINGDECHENLIDEZUIDALIZHIYUMEIGUOLIANBANGBIAOZHUN209EXIANGSHIYING,JI100JI(AHEBJI),10000JI(CJI),100000JI(DJI)。
AHEBJI(100JI)SHIYONGYUSHENGCHANWUJUNERYOUBUNENGZAIZUIHOURONGQIZHONGMIEJUNYAOPINDEPEIYEJIGUANFENG;FENZHENJIDEFENZHUANG、YAGAI、DASHUYEDEGUOLV、GUANFENG。
CJI(10000JI)SHIYONGYUDASHUYEDEXIPEI;XIAOZHENJIDEPEIYE、LVGUO、GUANFENGDENG。
DJI(100000JI)SHIYONGYUPIANJI、JIAONANGJI、WANJIDENGSHENGCHAN。
2、洁净室的气流组织
JIEJINGSHIDEQILIUZUZHIYESHIJINGHUAHUANJINGSHIXIANDEBAOZHENGCUOSHIFANGFAZHIYI。QILIUZUZHIYOUFEICENGLIUFANGSHIHUOCENGLIUFANGSHILIANGZHONG。YONGGAODUJINGHUADEKONGQIBACHEJIANNEICHANSHENGDEFENCHENXISHI,JIAOZUOFEICENGLIUFANGSHI(LUANLIUFANGSHI)。YONGGAODUJINGHUADEQILIUZUOWEIZAITI,BAFENCHENPAICHU,JIAOZUOCENGLIUFANGSHI。HOUZHEYOUCHUIZHICENGLIUHESHUIPINGCENGLIUFANGSHI。CONGFANGDINGFANGXIANGCHUIRUQINGJIEKONGQITONGGUODIPINGMIANPAICHUJIAOCHUIZHICENGLIUSHI,CONGCEBIFANGXIANGGUARUQINGJIEKONGQI,CONGDUIMIANCEBIPAICHUJIAOSHUIPINGCENGLIUSHI。ZHEIXIEFANGSHIFENBIERUTU1、TU2SUOSHI,BIAOSHILEGEZHONGFANGSHIDEMOSHITUHETEZHENG。LUANLIUFANGSHIYOUYUHUANQICISHUDEBIANHUAJIEJINGDUYESUIZHIBIANHUA,DANTONGCHANGJIEJINGDUYAOQIU10000JISHIHUANQICISHUZAI25~35CI/XIAOSHIFANWEINEI;JIEJINGDUYAOQIU100000JISHIHUANQICISHUZAI15~25CI/XIAOSHIFANWEINEI;JIEJINGDUYAOQIU300000JISHIHUANQICISHUZAI12~18CI/XIAOSHIFANWEINEIZAI100000JIFANWEI;CENGLIUFANGSHITONGCHANGGUIDINGLEQITILIUSUWEI025~05M/S。
ALUANLIUFANGSHIDEYOUDIANRUXIA:①GUOLVQIYIJIKONGQICHULIJIANBIAN;②SHEBEIFEIDI;③KUODAGUIMOBIJIAORONGYI;
④YUJINGHUATAILIANHESHIYONG,KEBAOCHIJISHUGAODEJIEJINGDU。
BLUANLIUFANGSHIDEQUEDIANRUXIA:①SHINEIJIEJINGDUSHOUZUOYERENYUANGANRAO;②YICHANSHENGWOLIUYOUWURANWEILIZAISHINEIXUNHUANDEKENENG;③HUANQICISHUSHAO,YINERJINRUZHENGCHANGYUNZHUANDESHIJIANZHANGDONGLIFEIZENGJIA;④BIXUCHONGFENZHUYIWANSHANYIMAOJIAN、GENGYISHI、FENGLINSHIDENGHUANCHONGSHI,QINGXIGONGZUOFUDENG。
CCHUIZHICENGLIUFANGSHIDEYOUDIAN:①BUSHOUSHINEIZUOYERENSHUZUOYEZHUANGTAIDEGANRAO,NENGBAOCHIGAOJIEJINGDU;②HUANQISHUFEICHANGDUO,JIHUZAIYUNZHUANDETONGSHICHENGWEIWENDINGZHUANGTAI;③CHENAIDUIJIHUOZAIPIAOFUFEICHANGSHAO,SHINEICHANSHENGDECHENAISUIQILIUYUNXINGBEICHUQU,XUNSUCONGWURANZHUANGTAIHUIFUDAOJIEJINGZHUANGTAI。
DCHUIZHICENGLIUFANGSHIDEQUEDIAN:①ANZHUANGZHONGLVQIYIJIJIAOHUANBANMAFAN,YIYINQIGUOLVQIMIFENGKOUDIANPOSUN;②SHEBEIFEIGAO;③KUODAGUIMOKUNNAN。
ESHUIPINGCENGLIUFANGSHIDEYOUDIAN:①YINWOLIU、SIJIAODENGYUANYIN,SHICHENAIDUIJIHUOZAIPIAOFUDEJIHUISHAO;②HUANQICISHUFEICHANGDUO,YINERZISHENJINGHUASHIJIANDUAN;③SHINEIJIEJINGDUBUDASHOUZUOYERENSHU,ZUOYEZHUANGTAIDEGANRAO。
FSHUIPINGCENGLIUFANGSHIDEQUEDIAN:①SHOUFENGMIANJINNENGBAOCHIGAOJIEJINGDU,DANJIEJINXIFENGMIAN,BANJINGDUZESUIZHIJIANGDI;②KUODAGUIMOKUNNAN;③SHEBEIFEIBUJIACHUIZHICENGLIUSHIGAO;④BIXUCHONGFENZHUYIWANSHANYIMAOJIAN,GENGYISHI,FENGLINSHIDENGHUANCHONGSHI,JINGCHANGQINGXIGONGZUOFUDENG。
BACAOZUOSHIQUANBUJINGHUASHEJICHENGSHANGSHUQILIUFANGSHI,FUJIASHEBEIFEIGAO,YINCIYOUBIYAOKAOLVCAIYONGJUBUJINGHUAFANGSHI。SHIJISHANGCENGLIUKONGQIJINGHUAFANGSHIYIBEICAIYONGZAIYIXIEGUANJIANSHEBEINEI,LIRUSHUYEDEGUANZHUANGSHEBEI、DONGGANZHENJIDEGUANZHUANGHEJIASAISHEBEIDENG,SHIYAOPINZAISHENGCHANGUANZHUANGSHIBAOLUYUKONGQIDEJUBUDADAO100JI,ZHEIYANGCHEJIANJIAODAHUANJINGDEJIEJINGDUBUJIUXUNEIMEGAO,ERQIESHIJISHANGYAOSHIYIGECHEJIANDEJIEJINGDUJUNDADAO100JISHIHENKUNNANDE。
3、生物洁净技术的原则
DUIWEISHENGWUWURANDEKONGZHI,CONGSHENGWUJIEJINGJISHUDEJIAODUERYAN,YOUSIGEYUANZE:
⑴DUIJINRUJIEJINGSHIDEKONGQICHONGFENDIJINXINGCHUJUNHUOMIEJUN;(RUYONGGAOXIAOLVQI、DIANZIZIJINGQI、CHOUYANGFASHENGQIDENG);
⑵SHISHINEIWEISHENGWUKELIXUNSUERYOUXIAODIXISHOUBINGBEIPAICHUSHIWAI;(HUANQICISHUJI DEJINFENGKOUYUHUIFENGKOUDESHEJI)
⑶BURANGSHINEIDEWEISHENGWULIZIJIJUHEYANSHENG(QILIUZUZHIXINGSHIJIHEGEDEJINGHUAZHUANGXIU);
⑷FANGZHIJINRUSHINEIDERENYUANHUOWUPINSANFAXIJUN,RUBUNENGFANGZHI,ZEYINGJINLIANGXIANZHIQIKUOSAN。
ZAISHANGSHUYUANZEZHONG:⑴、⑷LIANGXIANGYUCHUJUNJIMIEJUNDECUOSHI,CAOZUOJIGUANLIYOUGUAN。ER⑵、⑶LIANGXIANGYUSHINEIQILIUZUZHIHUANQICISHUYOUGUAN。LIANGHAODEQILIUZUZHIKEYISHIZHEILIANGXIANGNEIRONGDEYIYUANMANWANCHENG。
BIXUZHICHU:JIEJINGSHIWEISHENGWUDEWURANDEKONGZHI,SHIYANGEDEGUANLIHEXIANZHIRENYUANDECHUJUNYUMIQIEGUANLIANDE。LIANGHAODECHUCHEN、CHUJUNCUOSHI,LIRU:FANGCHENFU、FANGJINGDIANSHESHIDENGJUNSHISHENGWUJIEJINGJISHUZHONGSHIFENZHONGYAODENEIRONG。
4、净化过滤器方案的选择与特性
JINRUJIEJINGSHIDEJIEJINGKONGQIBUJINYAOYOUJIEJINGDUDEYAOQIU,HAIYINGYAOYOUWENSHIDUDEYAOQIU,JIEJINGSHIWENDUYIBANKONGZHIZAI18~26℃,XIANGDUICHENGDUWEI45%~75%ZHIJIAN,WEIBAOZHENGRENYUANDESHENGLIXUEYAOQIUXINFENGBIBUYINGXIAOYU15%,DANSHIZHENDUIGUIZHOUDIQUDEDUTEQIHOUTEDIAN(SIJIRUCHUN、QUANNIANSHIDUDA),ZAIGUTIZHIJI、TOUBAOZHIJI、FANGBAOCHEJIAN、DONGWUFANGDENGPAIFENGYAOQIUGAODEJINGHUAKONGDIAOXITONGZHONGKESHIDANGTIGAOXINFENGBI。
JINGHUAKONGDIAOXITONGYAOQUEBAOJIEJINGSHIDEJIEJINGDUBIXUSHEZHISANJIGUOLV,ZHIYAOSHENGCHANQIYEDEJINGHUAKONGDIAOXITONGYIBANSHEJICHUZHONGXIAOLIANGJIGUOLVYUZHONGYANGKONGDIAOJIZUZHONG,CAIYONGJIEJINGSHIMODUANGAOXIAOSONGFENGKOUJINXINGGAOXIAOGUOLVHOUDEJIEJINGFENGSONGRUJIEJINGSHI,ZHENGQUEXUANYONGCHUZHONGGAOXIAOGUOLVQISHIJIEJINGDUDABIAODEZHONGYAOYINSU:
⑴CHUXIAOLVQI:ZHUYAOSHILVCHUDAYU10WEIMIDECHENLI,YONGYUXINFENGGUOLVHEDUIKONGDIAOJIZUZUOBAOHU,LVLIAOWEIWY-CP-200DILUNWUFANGBU,TAYOUXIANGTI、LVLIAOHEGUDINGLVLIAODEKUANGJIASANBUFENZUCHENG。DANGLVCAIJICHENDAOYIDINGCHENGDU,TONGGUOCHUXIAOGUOLVDUANDEYACHABAOJINGZHUANGZHITIXINGCAOZUORENYUANJISHIGENGHUANGUOLVQI。CHUXIAOGUOLVQIYONGGUODELVCAIKEYISHUIXIZAISHENGZHONGFUSHIYONG。
⑵ZHONGXIAOLVQI:ZHUYAOSHILVCHU1-10WEIMIDECHENAIKELI,YIBANZHIYUGAOXIAOLVQIQIAN,FENGJIZHIHOU,YONGYUBAOHUGAOXIAOLVQI。YIBANWEIDAISHIZHONGXIAOLVQI,LVCAIWEIWZ-CP-2DILUNWUFANGBU。
⑶YAGAOXIAOLVQI:KELVCHUXIAOYU5WEIMIDECHENAIKELI,LVCAIYIBANWEIBOLIXIANWEIZHIPIN。
(4)GAOXIAOGUOLVQI(HEPA):ZHUYAOYONGYULVCHUXIAOYU1WEIMIDECHENAIKELI,YIBANZHUANGYUJINGHUAKONGDIAOTONGFENGXITONGMODUAN,JIGAOXIAOSONGFENGKOUSHANG,KEXUANYONGGB-01XINGGAOXIAOLVQI,LVCAIWEICHAOXIBOLIXIANWEIZHI,LVCHENXIAOLVWEI9997%YISHANG,GAOXIAOLVQIDETEDIANSHIXIAOLIGAO、ZULIDA。GAOXIAOLVQIYIBANNENGYONG2-3NIAN。
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成功案例
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广州医用口罩洁净无菌车间 |
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长沙天仪研究院洁净实验室 |
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