福建快三

科瓦特净化工程公司LOGO

全国咨询热线:400-6818-300

当前位置: 主页 > 资讯中心 > 行业资讯 >

GMP对制药厂房的洁净要求

2019-05-07 10:02:58   作者:kewatt  出处:科瓦特

  RUJINGUOJIADUISHENGWUZHIYAOXINGYEDEBIAOZHUNYUELAIYUEGUIFANHUAHEYANGEHUA,CONGGMPBIAOZHUNDEBUTONGSHENGJIKEYIKANCHUGUOJIAZHENGZAIYIGMPBIAOZHUNYANGEGUIFANDAOBUTONGXINGYEZHONGQU,JIEXIALAIXIAOBIANDAIDAJIALEJIEXIAGMPDUIZHIYAOCHANGFANGDEJIEJINGYAOQIU!

GMP洁净厂房

  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

空气洁净度等级

  HUANJINGJIEJINGDUSHIYIHUANJINGZHONGPIAOFUDEWEILIAOSHUHUOSHENGWULIZISHU(XIJUNSHU)LAIGUIDINGDEYIBANRENWEIQIANZHEDUODEHUANJINGXIAHOUZHEYEDUO,DANMEIYOUBIRANDELIANXI。DUIYAOPINSHENGCHANLAISHUO,ZAISHENGCHANHUANJINGZHONGCHULEDUIFEISHENGMINGWURANWU——CHENLIAOYAOJIAYIXIANZHICHULI,HAIBIXUDUIYOUSHENGMINGDEWURANWU——WEISHENGWUZUOCHUGENGYANGEDEXIANZHI。

  99BAN《GUIFAN》DUICHANGFANGDEJIEJINGDUJIBIEFENWEI100JI、10000JI、100000JIHE300000JISIGEDENGJI。1000JIDUIZHIYAOYELAISHUOBUSHISHIFENBIYAO,QIZAIDIANZIJIXIEXINGYEJIAOPUBIAN,>300000JIDEHUANJINGJIEJINGDUKONGZHIDUIZHIYAOYEWUTAIDADESHIJIYIYI。SHANGSHUSIJIYIJIBENKEMANZUGELEIYAOPIN、YUANLIAOYAODEGEGONGXUSHENGCHANHUANJINGDEJIEJINGYAOQIU,ERYU SHANGGMPDUICHANGFANGJIEJINGDUBIEHUAFENJIBENXIANGTONG。XINXIUDINGDE《GUIFAN》ZHONGCHANGFANGJIEJINGJIBIEFENLEIRUXIABIAO:

洁净级别表
WHO及欧洲共同体GMP厂房洁净度分类表
新版洁净级别表

  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。