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制药厂GMP净化车间对环境管理规范制度

2019-08-02 15:58:33   作者:kewatt  出处:科瓦特

  YAOCHANGDESHENGCHANGUANLIGUANHUZHEBAIXINGYONGYAODEANQUAN,GUOJIAGMPBIAOZHUNQIANGZHIYAOQIUZHIXING,WEILEWEIHUHAOGONGZUOHUANJING,QUEBAOCHANLIANGZHILIANG、ANQUANSHENGCHANJICHEJIANZHENGCHANGYUNZUO,TEZHIDINGBENZHIDUDUICHEJIANDEHUANJINGGUANLIGONGZUOJINXINGGUIFAN。

  1.范围

  BENWENJIANGUIDINGLESHENGCHANCHEJIANHUANJINGGUANLIGONGZUONEIRONG;

  BENWENJIANSHIYONGYUSHENGCHANCHEJIANHUANJINGGUANLI;

  2.职责

  2.1.GONGYIRENYUANFUZEZHIDINGBINGXIUGAIBENWENJIAN;

  2.2.SUOYOUCHEJIANGONGZUORENYUANXUYANGEZHIXINGBENWENJIAN;

  2.3.ANQUANYUANHEHUANJINGGUANLIRENYUANFUZEANWENJIANYAOQIUDUICHEJIANRENYUANJINXINGJIANCHA、JIANDU。

  3.车间内生产运行要求

  3.1.CHEJIANNEIYINGBAOCHITONGDAOCHANGTONG;DIMIANWUJICHEN,WUSHENSHUI、JISHUIXIANXIANG,DIMIANFANGHUA,WUYANDI,ZHIXIEDENGZAWU;

  3.2.CHEJIANBAOCHIZUGOUDEKONGDIAOTONGFENGHUANJINGHECAIGUANGZHAOMING;

  3.3.DIANLI、JIQIBUJUHEDIANXIANBUZHIYAOFUHEANQUANGUIFAN,XIAOFANGTONGDAOWUDUSAI,XIAOFANGQICAIQIBEI;

  3.4.KEGENJUGONGZUOHUANJINGXUYAO,QUEDINGSHIFOUSHEZHIYUSHENGCHANYAOQIUXIANGSHIYINGDEGENGYISHIHUOGENGYIJU,BINGBAOCHIGENGYISHIHEGENGYIJUDEQINGJIE;

  3.5.CHANPINZHIZAOGUOCHENGZHONGSHIYONGDEGONGQIJU、TUICHE、YUANFUCAILIAO、BANCHENGPINYINGZUNXUNZHENGQI、CUNQUFANGBIANDEYUANZE,FENLEIFANGZHIZHIDINGDIDIAN;

  3.6.XIABANHOUGEBANZUBIXUJIANGZAWU、LAJIQINGLICHUCHEJIANHUOZHIYUZHIDINGWEIZHI,BINGZHENGLI、QINGSAODIMIAN;

  3.7.MEIYUESHENGCHANRENYUANXUDUICHEJIANJINXINGCHEDIQINGLI,RUYOUBIYAOKESHIDANGZENGJIAPINCI;

  3.8.CHEJIANDIMIANDEQINGJIEGONGZUOBAOZHENGMEITIANBUSHAOYULIANGCI,BINGNENGJISHIDUICHEJIANNEIDELAJIJINXINGCHULI,QINGLIGUOCHENGZHONGYAOZHUYIZHOUWEISIJIAODEQINGJIEWEISHENG;

  3.9.GECHEJIANFUZERENXUDUIXINYUANGONG(BAOKUOXUEXI、DAIPEIRENYUAN)JINXINGCHEJIANJIANQUANHUANJINGJIAOYUHEBANZUANQUANHUANJINGJIAOYUPEIXUN;DUIYUANGONGJINXINGJINGCHANGXINGDEANQUANHUANJINGYISHI、ZHISHIHEJINENGJIAOYU;ZUZHIKAIZHANGEXIANGANQUANHUANJINGHUODONG,JIANCHA、DUCU、ZHIDAOBANZUKAIZHANANQUANHUANJINGHUODONG。DINGQIZHAOKAIANQUANHUANJINGHUIYI,JISHIJIEJUEANQUANHUANJINGWENTI,CHULIYUANGONGTICHUDEGEZHONGYIJIAN,JIANLIWANSHANCHEJIANANQUANHUANJINGZILIAOHEDANGAN。

  4.生产环境控制参数

  4.1KONGQIJINGHUADENGJIBIAOZHUN

   中国药品生产洁净室净化等级标准
中国药品洁净室悬浮尘粒与洁净度对照表

  YIBANYONGKONGQIJIEJINGDUBIAOSHISHENGCHANCHEJIANDEKONGQIJIEJINGDU。GECHEJIANDUISHENGCHANSUOXUDEKONGQIJIEJINGJIBIE(JIJIEJINGSHIDEKONGQICHENLISHU)YINGDINGQIJIANCEHEJILU,BINGTIANXIE《CHEJIANWENSHIDU、JIEJINGDUJILUBIAO》。DENGJIBUTONGDEJIEJINGSHIZHIJIANDEJINGYACHAYINGBAOCHIZAIGUIDINGSHUZHINEI,GESHENGCHANCHEJIANKONGQIJIEJINGJIBIERUBIAO2.

  药厂洁净区分为A,B,C,D


  AJIQU:GAOFENGXIANCAOZUOQU,RUGUANZHUANGQU,FANGZHIJIAOSAITONG,CHANGKOUANBUPING,CHANGKOUXILINPINGDEQUYUJIWUJUNZHUANGPEIXIANHUOLIANJIECAOZUODEQUYU。TONGCHANGYONGCENGLIUCAOZUOTAI(ZHAO)LAIWEICHIGAIQUDEHUANJINGZHUANGTAI。CENGLIUXITONGZAIQIGONGZUOQUYUBIXUJUNYUNSONGFENG,FENGSUWEI0.36--0.54M/S,(ZHIDAOZHI)。YINGYOUSHUJUZHENGMINGCENGLIUDEZHUANGTAIBINGXUYAOYANZHENG。ZAIMIBIDEGELICAOZUOQUHUOSHOUTAOXIANGNEI,KESHIYONGDANXIANGLIUHUOJIAODIDEFENGSU。

  BJIQU:ZHIWUJUNPEIZHIHEGUANZHUANGDENGGAOFENGXIANCAOZUOAJIQUSUOCHUDEBEIJINGQUYU。

  CJIQUHEDJIQU:ZHISHENGCHANWUJUNYAOPINGUOCHENGZHONGZHONGYAODECHENGDUJIAODIDEJIEJINGCAOZUOQU。

  新版GMP洁净度等级A、B、C、D


  A级洁净区

  JIEJINGCAOZUOQUDEKONGQIWENDUYINGWEI20-24℃

  JIEJINGCAOZUOQUDEKONGQIXIANGDUISHIDUYINGWEI45%-60%

  CAOZUOQUDEFENGSU:SHUIPINGFENGSU≥0.54m/s

  CHUIZHIFENGSU≥0.36m/s

  GAOXIAOGUOLVQIDEJIANLOUDAYU99.97%

  ZHAODU:>300lx-600lx

  ZAOYIN:≤75db(DONGTAICESHI)

  B级洁净区

  JIEJINGCAOZUOQUDEKONGQIWENDUYINGWEI20-24℃

  JIEJINGCAOZUOQUDEKONGQIXIANGDUISHIDUYINGWEI45%-60%

  FANGJIANHUANQICISHU:≥25CI/h

  YACHA:BJIQUXIANGDUISHIWAI≥10Pa,TONGYIJIBIEDEBUTONGQUYUANQILIULIUXIANGYINGBAOCHIYIDINGDEYACHA。GAOXIAOGUOLVQIDEJIANLOUDAYU99.97%

  ZHAODU:>300lx-600lx

  ZAOYIN:≤75db(DONGTAICESHI)

  C级洁净区

  JIEJINGCAOZUOQUDEKONGQIWENDUYINGWEI20-24℃

  JIEJINGCAOZUOQUDEKONGQIXIANGDUISHIDUYINGWEI45%-60%

  FANGJIANHUANQICISHU:≥25CI/h

  YACHA:CJIQUXIANGDUISHIWAI≥10Pa,TONGYIJIBIEDEBUTONGQUYUANQILIULIUXIANGYINGBAOCHIYIDINGDEYACHA。GAOXIAOGUOLVQIDEJIANLOUDAYU99.97%

  ZHAODU:>300lx-600lx

  ZAOYIN:≤75db(DONGTAICESHI)

  D级洁净区

  JIEJINGCAOZUOQUDEKONGQIWENDUYINGWEI18-26℃

  JIEJINGCAOZUOQUDEKONGQIXIANGDUISHIDUYINGWEI45%-60%

  FANGJIANHUANQICISHU:≥15CI/h

  YACHA:100,000JIQUXIANGDUISHIWAI≥10Pa,

  GAOXIAOGUOLVQIDEJIANLOUDAYU99.97%

  ZHAODU:>300lx-600lx

  ZAOYIN:≤75db(DONGTAICESHI)

  静态测量:是指所有设备均已安装就绪,但未运行且没有操作人员在现场的状态。

  动态测量:是指生成设备均按预定的工艺模式运行且有规定数量的操作人员在现场操作的状态。

  JIEJINGSHIYUZHOUWEIDEKONGJIANBIXUWEICHIYIDINGDEYACHA,BINGYINGANSHENGCHANGONGYIYAOQIUJUEDINGWEICHIZHENGYACHAHUOFUYACHA。BUTONGDENGJIDEJIEJINGSHIYIJIJIEJINGQUYUFEIJIEJINGQUZHIJIANDEYACHA,YINGBUXIAOYU5Pa,JIEJINGQUYUSHIWAIDEYACHA,YINGBUXIAOYU10Pa。

  温度与湿度环境要求控制

  JIEJINGCHEJIANDEWENDUHEXIANGDUISHIDUYINGYUQISHENGCHANGONGYIYAOQIUXIANGSHIYING,JUTICANSHUJIANXINBANGMPBIAOZHUNABCDDENGJIYAOQIU:

  JIEJINGCAOZUOQUDEKONGQIWENDUYINGWEI20-24℃JIEJINGCAOZUOQUDEKONGQIXIANGDUISHIDUYINGWEI45%-60%。GECHEJIANDUISHENGCHANSUOXUDESHIWENDUYINGDINGQIJIANCEHEJILU,BINGTIANXIE《CHEJIANWENSHIDU、JIEJINGDUJILUBIAO》。

  5.出入车间要求

  5.1.WEIJINGYUNXU,FEISHENGCHANRENYUANYILVBUDESIZIJINRUCHEJIAN;

  5.2.JINRUCHEJIANBIXUANZHAOYAOQIUCHUANDAIGONGZUOFU(GONGZUOFUXUANYAOQIUQINGXI),TOUFABUDEPILU;

  5.3.GONGZUOQIJIANBUDECHUANGONGZUOFUWAICHU,RUWAICHUXUTUODIAOGONGZUOFU;

  5.4.CHEJIANNEIYANJINCUNFANGGERENSHENGHUOYONGPINHEYUSHENGCHANWUGUANDEZAWU;YANJINYINSHI、XIYAN、LUANRENGZAWUHESUIDITUTAN。

  5.5.QIANHOUQINGXI、PECVD、SIWANGYINSHUA、CESHIFENXUANGONGXUYAOQIU

  5.6.GANGWEISHANGYANJINCUNFANGGERENSHENGHUOYONGPINHEYUSHENGCHANWUGUANDEZAWU;YANJINYINSHI、XIYAN、LUANRENGZAWUHESUIDITUTAN;

  5.7.GANGWEISHANGBIXUANZHAOYAOQIUCHUANDAIGONGZUOFU(GONGZUOFUXUANYAOQIUQINGXI)、KOUZHAO、GONGZUOXIE、GONGZUOMAO、RUJIAOSHOUTAO,TOUFABUDEPILU;

  5.8.BUDEZAIGANGWEISHANGDANAO、WANSHUA;

  5.9.JIEYUENENGYUAN、AIXICAILIAO,DUJUELANGFEIYINSU;

  5.10.MEITIANXIABANSHI,QINGLIGONGZUOTAIMIANHEJIQISHEBEIQINGJIE,TAIMIANWEISHENG,ZUOHAOWEISHENGZHIRIGONGZUO,RICHANGFUZEDASAOCHEJIANQINGJIEWEISHENG;

  5.11.YUANGONGBUDEZAIGANGWEISHANGTUOQUGONGZUOFU;

  5.12.YUANGONGBUDEJIANGGERENWUPIN(SHOUTIBAO、DIANNAO、YIWUDENG)DAIRUGONGZUOGANGWEI;

  5.13.YUANGONGGONGZUOFUBIXUDINGSHIQINGXI,BAOCHIQINGJIE;

  6.扩散工序要求

  6.1.KUOSANQUNEIZUOYERENYUANDESHUMUZUNXUNZUIXIAOXIANDUYUANZE(YUESHAOYUEHAO)。ZUOYEYUANBIXUANZHAOGUIDINGCHUANZHEJIEJINGFU、ZAIZHANCHENDIANSHANGQINGJIESUOYOUJIEJINGXIE,BINGJINRUFENGLINSHIJINXINGFENGLINQINGJIEZHIHOU,FANGKEJINRUKUOSANQU;

  6.2.ZAIKUOSANQUNEIZUOYEYUANXUBAOCHIGERENGEFANGMIANDEGANJINGYUQINGJIE;

  6.3.ZAIKUOSANQUNEIZUOYERENYUANHUOQITARENYUANDEYIDONGHUODONGZUOJUNWEIFACHENYUAN,QIZHIJIEYINGXIANGZHICHENG,TONGSHIYEHUIYINGXIANGQILIURAODONG。

  WEIFANGZHIYUKONGZHISHANGSHUQINGKUANG,XUZHUYIYIXIAJIDIAN:

  A、JINLIANGBIMIANBUBIYAODEDONGZUO,YIFANGZHILUANLIUFACHEN;

  B、ZUOYEYAOZAIJIEJINGJUHUOJIEJINGGONGZUOTAISHANGGONGZUO;

  C、BIMIANYUZUOYEWUGUANDEHUATI;

  D、WEIKONGZHIFACHENLIANG,RENYUANXINGZOUJIZUOYEYUYAOJINGJINGDIJINXING;

  6.4.XIALIESUOSHUZHEBUDEJINRUKUOSANQU

  A、FEIZUOYEYUANHUOSHIXIANWEIDEXUKEZHE;

  B、WEIANZHAOGUIDINGCHUANZHEJIEJINGFUZHE;

  C、ZUOYEYUANHUAZHUANGHUOZHETUZHIJIAYOUBUDEJINRU;

  6.5.YIXIAWUPINBUDEDAIRUKUOSANQU:

  A、MEIYOUJINGGUOQINGJIEDEQICAI、LINGJIANWUPIN、CESHIYIQIDENGGEZHONGWUPIN;

  B、ZHIXIANGJIWEIJINGTEBIECHULIDEJILUHUOBIJIYONGZHI、YINGYINSHUJUDENG;

  C、XIANGSHUI、HUAZHUANGPIN、WEISHENGZHI、YINLIAOSHIPIN、DAHUOJI、QIANBAODENG;

  6.6.KUOSANQUNEIWULIAO、SHEBEIGUANLI

  ZUOYERENYUANZAIKUOSANQUQINGJIESHEBEIHUOWULIAOSHIBIXUCHUANZHEJIEJINGFU。SUOSHIYONGDECASHIZHIBIXUWEIWUCHENZHI。BANYUNSHEBEISHIBIMIANPOHUAIDIBANZHIJIEJIDIBANBIAOMIAN。