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制药企业洁净厂百级洁净区作法探讨

制药企业洁净厂百级洁净区作法探讨

制药企业洁净厂百级洁净区作法探讨

ZHIYAOCHANGYUGMPZHIYAOQIYEJIEJINGCHANGFANGBAIJIJIEJINGQUZUOFATANTAO  

五百万彩票网YAOPINSHENGCHANCHANGFANGJIEJINGCHEJIANNEI,JINGCHANGHUIYOUJUBUBAIJIQU,HUOYAOQIUMOUYIGEFANGJIANHUOJIGEFANGJIANWEIBAIJI,HUOYAOQIUMOUGEFANGJIANNEIBUFENQUYUWEIBAIJI,ZHEIXIEBAIJIQUMIANJIYIBANDOUBUDA,CONGJISHIPINGFANGMIDAOJIPINGFANGMISHENZHILINGDIANJIPINGFANGMIBUDENG,TONGCHANGWEIYIGEJIEJINGQUNEIGONGYILIUSHUIXIANDEYIBUFEN,DANTAMENZAIJIEJINGCHANGFANGZHONGDOUYOUZHEFEICHANGZHONGYAODEZUOYONG。TAMENWANGWANGSHIGAICHEJIANGONGYILIUCHENGDEHEXINBUWEI,BIRUWUJUNYAOPINZHUSHEJIDEGUANFENG、FENZHUANG、YASAI、SHENGWUZHIPINDEGUANFENG、DONGGAN、JIASAIDENGBUWEI,BAIJIQUNENGFOUZHENGCHANGYUNXING,ZHIJIEYINGXIANGDAOCHANPINZHILIANG。XIAMIANJIEHEYAOPINSHENGCHANCHANGFANGJIEJINGCHEJIANDETEDIAN,JIESHAOJIZHONGBAIJIQUDEZUOFA。

GENJU《YAOPINSHENGCHANZHILIANGGUANLIGUIFAN》(GMP)(1998NIANXIUDING)YAOQIU,MUQIAN,YAOPINSHENGCHANCHANGFANGGENJUSHENGCHANPINZHONGBUTONG,JIEJINGQUYIBANFENWEISANSHIWANJI、SHIWANJI、WANJIHEBAIJISIGEJIEJINGJIBIE,BAIJIQUWEIZUIGAOJIEJINGDUJIBIE。BAIJIQUYIBANWEIYUCHEJIANDENEIQU,ZHOUWEIYOUWANJIQUHUOSHIWANJIQU,BAIJIQUWEICHEJIANLIUSHUIXIANYIBUFEN,ZHENGGELIUSHUIXIANHAIBAOKUOWANJIQUHUOSHIWANJIQU。BAIJIQUYIBANCENGGAOJIAODI(≤2.8m),HUANJINGFENGBI,DUIZAOSHENGYAOQIUJIAOGAO(《JIEJINGCHANGFANGSHEJIGUIFAN》YAOQIU≤65dB(A))。BAIJIQUDIAODINGZHOUWEIFENGGUANJIAODUO,YONGYUBAIJIQUCHULISONGFENGDEKONGJIANBIJIAOJINZHANG。




1 BAIJIQUWEN、SHIDUKONGZHIJIBUCHONGXINFENGFANGSHI

YAOPINSHENGCHANCHANGFANGJIEJINGQUBAIJIQUMIANJIJIAOXIAO,TONGCHANGYUWANJIJIEJINGQUTONGSHUYIGEGONGYILIUSHUIXIAN,YUWANJIJIEJINGQUWEN、SHIDUYAOQIUXIANGTONG,YUNXINGBANCIXIANGTONG,BAIJIJIEJINGQUWEN、SHICHULIYUBUCHONGXINFENG,KEYIYUQIWANJIJIEJINGQUTONGCHOUKAOLV,RUTU1SUOSHI,CAIYONGYITAOZUHEKONGDIAOQICHULIWANJIQUHEBAIJIQUKONGDIAOXITONGSONGFENG。


五百万彩票网 BAIJIQUYINGKAOLVFFU(Fan Filter Unit)FENGJIFARELIANG,SHIDANGJIADAHUANQICISHU,PINGHENGBAIJIQUYUWANJIQUFANGJIANDEWEN、SHIDU,GEGEFANGJIANGONGYISHEBEIDEFARELIANG、SANSHILIANGYETONGYANGKAOLV。


五百万彩票网CIZHONGCHULIFANGSHI,YOURUXIAYOUDIAN:①KONGQICHULIXITONGJIANDAN。BIMIANBAIJIQUZAILINGSHEYITAOXIAOXINGKONGQICHULIXITONGHUOXINFENGCHULIXITONG。②BIMIANZAIBAIJISHUFENGDAONEISHEGANPANGUAN,YEBIMIANLEYINSHEGANPANGUANYINQIDEYIXILIEWENTI,BIRUGANPANGUANLENGYUANWENTI,YINWEIZHEILIGANPANGUANXULENGDONGSHUILIANGHENSHAO,YIBANBUZU2m3/h,YOUBUYIZHIJIECAIYONGKONGDIAOXITONGLENGDONGSHUI(7-12℃SHUI),YINWEISHUIWENTAIDI,KEYINQIJIELU,WURANBAIJIQUSHUFENGDAOHUANJING;ZHUANGGANPANGUANHOUYINQIFFUXITONGFENGJIYATOUBUZU,XUZAIJIAYADENGWENTI。GONGCHENGSHIJIANZHENGMING,CAIYONGCIZHONGKONGQICHULIFANGSHI,XIAOGUOJIAOHAO。BAIJIQUDEWEN、SHIDU、ZHENGYAZHI、JIEJINGDUDOUNENGDEDAOJIAOHAODEBAOZHENG。ZHENGGELIUSHUIXIAN,WANJIQUHEBAIJIQUWEIYITAOKONGDIAOXITONG,TONGSHIYUNXING,TONGYIKONGZHI,TONGYIDIAOJIEWEN、SHIDU,JIANBIAN、KEKAOXINGGAO。


2 BAIJIQUXUNHUANFENGCHULIFANGSHI

五百万彩票网YAOPINSHENGCHANCHANGFANGBAIJIQUTONGCHANGWEICHUIZHICENGLIU,DUANMIANFENGSUKONGZHIZAI0.25~0.3m/sWEIYI,TAIDAZELANGFEI,TAIXIAOZEBUYIBAOZHENGJIEJINGDU。XUNHUANFENGLIANGYINGBABAIJIQUSONGFENGLIANGKAOLVZAINEI。YAOPINSHENGCHANCHANGFANGBAIJIQUXUNHUANFENGCHULIFANGSHIYIBANYOURUXIAJIZHONG:


五百万彩票网DIYIZHONGFANGSHI,ZAIBAIJIQUSHANGBUSHEJINGYAXIANG,BAIJIQUDIAODINGMANBUFFUFENGJIJINGHUADANYUAN,RUTU1,XUNHUANFENGCONGBAIJIQUCEQIANGXIABUJINRUSHUFENGDAO,TONGGUOSHUFENGDAOJINRUJINGYAXIANG,JINGFFUSONGRUSHINEI, FFUBENSHENJIDAIGAOXIAOGUOLVQI,YOUYOUFENGJI。CIZHONGFANGSHI,XUNHUANFENGJIAYAGUOLVJUNYOUFFUWANCHENG,CHULIFANGSHIBIJIAOJIANDAN,ZAIBAIJIQUDIAODINGNEIJIKEWANCHENGXUNHUANFENGCHULI。KONGDIAOXITONGBUJUJINCOU、FANGBIAN,SHIGONGBIJIAOJIANDAN。BAIJIQUSHANGBUJINGYAXIANGXIANGDUIBAIJIQUWEIFUYA,BAIJIQUDINGPENGFFUYUDIAOJIAJIANDESHENLOU,WEISHINEILIUXIANGJINGYAXIANG,DUIBAIJIQUJIEJINGDUZAOCHENGYINGXIANGJIAOXIAO。JINNIANLAI,SUIZHEFFUZHIZAOJISHUDETIGAO, FFUDANJICHENGBEN、ZAOSHENGBUDUANXIAJIANG,FENGJIXIAOLVBUDUANTIGAO。YAOPINSHENGCHANCHANGFANGBAIJIQUCAIYONGFFUCHULIFANGSHIYUELAIYUEDUO。MUQIANFFUCHANPINDANJIZAOSHENGDUOZAI52~57dB(A)ZHIJIAN,RUOCAIYONGFFUSHULIANGJIAODUO,JISHITAISHENZHIGENGDUO,ZEBAIJIQUDEZAOSHENGNANYIDADAOGUIFANYAOQIU,ZAOJIAYEJIAOGAO。


DIERZHONGFANGSHI。BAIJIQUSHANGBUSHEJINGYAXIANG,DINGPENGMANBUGAOXIAOGUOLVQI(MANBULVYING≥65%)RUTU2,CAIYONGXUNHUANFENGJI,CONGBAIJIQUSHUFENGDAOJINFENG,JIAYAHOUSONGRUJINGYAXIANG,TONGGUODINGPENGGAOXIAOGUOLVQI,SONGRUSHINEI。


CIZHONGFANGSHIYOURUXIAYOUDIAN:①BAIJIQUZAOJIAJIAOFFUXITONGDI;②NENGGOUJIAOHAODEKONGZHIXUNHUANFENGXITONGZAOSHENG。YAOPINSHENGCHANCHANGFANGBAIJIJIEJINGQUMIANJIJIAOXIAO,XUNHUANFENGLIANGDUOZAI50000m3/hYINEI(BAOZHENG50m2BAIJIQU)。SHIJIGONGCHENGZHONGKECAIYONGDUOTAIXUNHUANFENGJIJIAYA,KONGZHIXUNHUANFENGJIQUANYAZAI420PaYINEI。ZHEIYANG,CAIYONGXIAOGONGLVFENGJI,JIANXIAOFENGJIBENSHENZAOSHENG,BINGTONGGUOZAIFENGJIJIN、CHUKOUFENGGUANSHANGANZHUANGXIAOSHENGQIDENGCUOSHI,NENGYOUXIAOKONGZHIBAIJIQUZAOSHENG。BENRENSHEJIDESHENZHENMOUYIYAOQIYESHENGWUGONGCHENGCHEJIANDONGGANFENZHENLIUSHUIXIAN,BAIJIQUGUANFENGJIANMIANJIWEI4.5m×6.6m,CAIYONGSHANGSHUFANGSHICHULIBAIJIQUXUNHUANFENG,XUANYONG3TAILIXINFENGJIZUOXUNHUANFENGJIXIANG,SHEZAIGUANFENGJIANGEBIDONGGANJIFANGNEI(DONGGANJIFANGWEIFEIJIEJINGQU,XIAOSHENGQIYESHEZAIDONGGANJIFANGNEI),FENGLIANG9600m3/h·TAI,QUANYA405Pa,ZAOSHENG66dB(A),TONGGUOZAIFENGJIXIANGNEITIEXISHENGCAILIAO,ZAIFENGJIJIN、CHUKOUFENGGUANANZHUANGXIAOSHENGQI,KONGZHIFENGGUANNEIFENGSUDENGKONGZHIZAOSHENGCUOSHI。BAIJIQUNEIJINGTAIZAOSHENG62dB(A),DADAOGUIFANYAOQIU。ZHIJINJINGGUO2NIANDUODEYUNXING,XIAOGUOLIANGHAO。



五百万彩票网CIFANGSHIDEQUEDIANSHISHEZHIXUNHUANFENGJIXIANGJICHULIZAOSHENG,XUYAOJIAODADEKONGJIAN,ERTONGCHANGBAIJIQUZHOUWEIFENGGUANDOUBIJIAOMIJI,XUYAOJINGXINBUJU。CIFANGSHIBAIJIQUSHANGBUJINGYAXIANGXIANGDUIBAIJIQUSHINEIWEIZHENGYA,DINGPENGGAOXIAOGUOLVQIYUDIAOJIAJIANDESHENLOU,WEIJINGYAXIANGLIUXIANGSHINEI,ZHIJIEYINGXIANGBAIJIQUJIEJINGDU。DUISHIGONGZHILIANGYAOQIUJIAOGAO。


五百万彩票网DISANZHONGFANGSHI,WANJIQUJIEJINGFANGJIANNEIHANJUBUBAIJIQU。CIZHONGQINGKUANGZAIYAOPINSHENGCHANCHANGFANGJIEJINGQUNEIYEBIJIAODUOJIAN。ZHEIZHONGQINGKUANG,JUBUBAIJIQUMIANJIYIBANZAI10m2YINEI。KEYILIYONGWANJIJINGHUAKONGDIAOXITONGSONGFENGKONGZHISHINEIWEN、SHIDU,BUCHONGXINFENG。ZAIJUBUBAIJIQUJIADAXUNHUANFENGLIANG。XUNHUANFENGCHULIFANGSHIKEYICAIQUQIANSHUFANGSHIYI,JIZAIJUBUBAIJIQUDIAODINGNEIZUOJINGYAXIANG,BAIJIQUFANWEINEIMANBUFFU,LIYONGFFUCHULIXUNHUANFENG,RUTU3。XUNHUANFENGCHULIFANGSHIYEKECAIQUQIANSHUFANGSHIER,JIZAIJUBUBAIJIQUDIAODINGNEIZUOJINGYAXIANG,BAIJIQUFANWEINEIMANBUGAOXIAOGUOLVQI,LIYONGXUNHUANFENGJIJIAYA,


WEILETIGAOJUBUBAIJIQUQILIUCHUIZHICENGLIUXIAOGUO,KEYIGENJUXIANCHANGGONGYISHEBEIGAODUJICAOZUOYAOQIU,SHIDANGJIANGDIJUBUBAIJIQUDIAODING,HUOZAIJIEJINGQUDIAODINGXIAZHIJIEPINZHUANGBAIJICENGLIUZHAO,BINGZAIBAIJIQUBIANJIECHUZHUANGKANGJINGDIANSULIAOQUNDANG,



3 BAIJIQUXUNHUANFENGHUIFENGFANGSHI

BAIJIQUXUNHUANFENGHUIFENGFANGSHIKEYICAIQUGEZHADIBANHUIFENG,RUTU6,HUOCEQIANGXIABUHUIFENG。RUTU1ZHITU5。


五百万彩票网GEZHADIBANHUIFENGFANGSHI,SHINEIQILIUCHUIZHICENGLIUXIAOGUOHAO,DANXUYAOZAIGEZHAHUIFENGDIBANXIASHEHUIFENGJINGYAXIANG(YUE500mm~800mmGAO),YIBANCAIQUJIANGDIBAIJIQUDIPING。DANZAISHIJISHISHIZHONG,JIANGDIBAIJIQUDIPINGWANGWANGNANYIYUZHOUWEIJIEJINGQUFANGJIANXIEDIAO,NANDUJIAODA,ZAOJIASHENGGAO。


YAOPINSHENGCHANCHANGFANGBAIJIQUMIANJIJIAOXIAO,TONGGUOHELIBUZHICEQIANGXIAHUIFENGKOUYIBANNENGMANZUBAIJIQUQILIUCHUIZHICENGLIUYAOQIU,SHIGONGFANGBIAN,ZAOJIAJIAODI。YOUGUANZILIAOBIAOMING,CAIQUFANGJIANLIANGDUICEQIANGXIABUHUIFENG,DANGFANGJIANKUANDUXIAOYU3mSHI,FANGJIANCHUIZHICENGLIUQILIUKEYIDAODADIPINGSHANG0.3mCHU。SHIJISHISHISHI,KEYICAIQUZAIBAIJIQUSIMIANCEQIANGXIABUZHIHUIFENGKOU。RUOFANGJIANKUANDUJIAODA,KEYICAIQUZAIFANGJIANZHONGYANGZENGSHEHUIFENGSHUJING,ZAISHUJINGSIMIANBUZHICEHUIFENGKOU,JIANSHAOFANGJIANDUICEQIANGHUIFENGKOUJIANJU,BAOZHENGFANGJIANQILIUCHUIZHICENGLIUXIAOGUO。


QITAYAOQIU,BAIJIQUFANGJIANCEHUIFENGKOUFENGSU,YINGANGUIFANYAOQIUKONGZHIZAI1.5~2.0m/s。YAOPINSHENGCHANCHANGFANGBAIJIQUFANGJIANWANGWANGYOUGONGYILIUSHUIXIANCHUANCHU,YUQITAJIEJINGQUFANGJIANXIANGTONG,GONGYILIUSHUIXIANCHUANQIANGCHULIUYOUKONGDONG。SHIGONGZHONG,YINGJINLIANGJIANXIAOKONGDONG,ZAIJISUANBAIJIQUZHENGYAFENGLIANGSHI,YINGKAOLVTONGGUOGAIKONGDONGXIELOUDEZHENGYAFENGLIANG,SHIDANGJIANSHAOTONGGUOBAIJIQUFANGJIANDEHUIFENGLIANG。


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