《JIEJINGCHANGFANGSHEJIGUIFAN》ZHONGKONGQIJIEJINGDUDENGJI

　　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。