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惠源水处理---十年专注于纯化水设备的研发和制造

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2015版GMP认证对纯化水设备要求

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扫一扫!2015版GMP认证对纯化水设备要求扫一扫!
浏览:- 发布日期:2018-09-25 10:25:58【

顺发彩票投注 2015BANGMPRENZHENGDUICHUNHUASHUISHEBEIYAOQIU(GMPYAODIANGUIDING)

(一)、纯化水设备设计要求

顺发彩票投注 1、JIEGOUSHEJIYINGJIANDAN、KEKAO、CHAIZHUANGJIANBIAN。

2、WEIBIANYUCHAIZHUANG、GENGHUAN、QINGXILINGJIAN,ZHIXINGJIGOUDESHEJIJINLIANGCAIYONGDEBIAOZHUNHUA、TONGYONGHUA、XITONGHUALINGBUJIAN。

3、SHEBEINEIWAIBIBIAOMIAN,YAOQIUGUANGHUAPINGZHENG、WUSIJIAO,RONGYIQINGXI、MIEJUN。LINGJIANBIAOMIANYINGZUODUGEDENGBIAOMIANCHULI,YINAIFUSHI,FANGZHISHENGXIU。SHEBEIWAIMIANBIMIANYONGYOUQI,YIFANGBOLUO。

顺发彩票投注 4、ZHIYAOCHUNHUASHUISHEBEIYINGCAIYONGDITANBUXIUGANGHUOQITAJINGYANZHENGBUWURANSHUIZHIDECAILIAO。ZHIBEICHUNHUASHUIDESHEBEIYINGDINGQIQINGXI,BINGDUIQINGXIXIAOGUOYANZHENG。

5、ZHUSHEYONGSHUIJIECHUDECAILIAOBIXUSHIYOUZHIDITANBUXIUGANG(LIRU316LBUXIUGANG)HUOQITAJINGYANZHENGBUDUISHUIZHICHANSHENGWURANDE CAILIAO。ZHIBEIZHUSHEYONGSHUIDESHEBEIYINGDINGQIQINGXI,BINGDUIQINGXIXIAOGUOYANZHENG。

6、CHUNHUASHUICHUCUNZHOUQIBUYIDAYU24XIAOSHI,QICHUGUANYICAIYONGBUXIUGANGCAILIAOHUOJINGYANZHENGWUDU,NAIFUSHI,BUSHENCHUWURANLIZIDEQITACAILIAOZHIZUO。BAOHUQITONGQIKOUYINGANZHUANGBUTUOLUOXIANWEIDESHUSHUIXINGCHUJUNLVQI。CHUGUANNEIBIYINGGUANGHUA,JIEGUANHEHANFENGBUYINGYOUSIJIAOHESHAYAN。YINGCAIYONGBUHUIXINGCHENGZHISHUIWURANDEXIANSHIYEMIAN、WENDUYALIDENGCANSHUDECHUANGANQI。DUICHUGUANYAODINGQIQINGXI、XIAODUMIEJUN,BINGDUIQINGXI、MIEJUNXIAOGUOYANZHENG。

7、YALIRONGQIDESHEJI,XUYOUYOUXUKEZHENGDEDANWEIJIHEGERENYUANCHENGDAN,XUANZHONGHUARENMINGONGHEGUOGUOJIABIAOZHUN《GANGZHIYALIRONGQI》(GB150-80)JI”YALIRONGQIANQUANJISHUJIANCHAGUICHENG”DEYOUGUANGUIDINGBANLI。

8、ZHIYAOYONGSHUIDESHUSONG

1)CHUNHUASHUIHEZHIYAOYONGSHUIYICAIYONGYICHAIXIEQINGXI、XIAODUDEBUXIUGANGBENGSHUSONG。ZAIXUYONGYASUOKONGQIHUODANQIYASONGDECHUNHUASHUIHEZHUSHEYONGSHUIDECHANGHE,YASUOKONGQIHEDANQIXUJINGHUACHULI。

2)CHUNHUASHUIYICAIYONGXUNHUANGUANLUSHUSONG。GUANLUSHEJIYINGJIANJIE,YINGBIMIANMANGGUANHESIJIAO。GUANLUYINGCAIYONGBUXIUGANGGUANHUOJINGYANZHENGWUDU、NAIFUSHI、BUSHENCHUWURANLIZIDEQITAGUANCAI。FAMENYICAIYONGWUSIJIAODEWEISHENGJIFAMEN,SHUSONGCHUNHUASHUIYINGBIAOMINGLIUXIANG。

3)SHUSONGCHUNHUASHUIHEZHUSHEYONGSHUIDEGUANDAO、SHUSONGBENGYINGDINGQIQINGXI、XIAODUMIEJUN,YANZHENGHEGEHOUFANGKETOURUSHIYONG。

(二)、纯化水设备选材安装( 药品GMP实施与认证P168)(对于药厂来说)

DI31TIAOSHEBEIDESHEJI、XUANXING、ANZHUANGYINGFUHESHENGCHANYAOQIU,YIYUQINGXI、XIAODUHUOMIEJUN,BIANYUSHENGCHANCAOZUOHEWEIXIU、BAOYANGBINGNENGFANGZHICHACUOHEJIANSHAOWURAN。

DI32TIAOYUYAOPINZHIJIEJIECHUDESHEBEIBIAOMIANYINGGUANGHUA、PINGZHENG、YIQINGXIHUOXIAODU、NAIFUSHIBUYUYAOPINFASHENGHUAXUEBIANHUAHUOXIFUYAOPIN。SHEBEISUOYONGDERUNHUAJI、LENGQUEJIDENGBUDEDUIYAOPINHUORONGQIZAOCHENGWURAN。

顺发彩票投注 DI33TIAOYUSHEBEILIANJIEDEZHUYAOGUDINGGUANDAOYINGBIAOMINGGUANNEIWULIAOMINGCHENG、LIUXIANG。

顺发彩票投注 DI34TIAOCHUNHUASHUI、ZHUSHEYONGSHUIDEZHIBEI、CHUCUNHEFENPEIYINGNENGFANGZHIWEISHENGWUDEZISHENGHEWURAN。CHUGUANHESHUSONGGUANDAOSUOYONGCAILIAOYINGWUDU、NAIFUSHI。GUANDAODESHEJIHEANZHUANGYINGBIMIANSIJIAO、MANGGUANCHUGUANHEGUANDAOYAOGUIDINGQINGXI、MIEJUNZHOUQI。ZHUSHEYONGSHUICHUGUANDETONGQIKOUYINGANZHUANGBUTUOLUOXIANWEIDESHUSHUIXINGCHUJUNLVQI。ZHUSHEYONGSHUIDECHUCUNKECAIYONG80°CYISHANGBAOWEN、65°CYISHANGBAOWENXUNHUANHUO4°CYIXIACUNFANG。

顺发彩票投注 DI35TIAOYONGYUSHENGCHANHEJIANYANDEYIQI、YIBIAO、LIANGJU、HENGQIDENG,QISHIYONGFANWEIHEJINGMIDUYINGFUHESHENGCHANHEJIANYANYAOQIU,YOUMINGXIANDEHEGEBIAOZHI,BINGDINGQIXIAOYAN。

顺发彩票投注 DI36TIAOSHENGCHANSHEBEIYINGYOUMINGXIANDEZHUANGTAIBIAOZHI,BINGDINGQIWEIXIU、BAOYANGHEYANZHENG。SHEBEIANZHUANG、WEIXIU、BAOYANGDECAOZUOBUDEYINGXIANGCHANPINDEZHILIANG。BUHEGEDESHEBEIRUYOUKENENGYINGBANCHUSHENGCHANQU,WEIBANCHUQIANYINGYOUMINGXIANBIAOZHI。

DI37TIAOSHENGCHAN、JIANYANSHEBEIJUNYINGYOUSHIYONG、WEIXIU、BAOYANGJILU,BINGYOUZHUANRENGUANLI。

(三)、设备清洗要求

SHEBEIDEQINGXIGUICHENGYINGZUNXUNYIXIAYUANZE:

顺发彩票投注 1、YOUMINGQUEDEXIDIFANGFAHEXIDIZHOUQI。

顺发彩票投注 2、MINGQUEGUANJIANSHEBEIDEQINGXIYANZHENGFANGFA。

3、QINGXIGUOCHENGJIQINGXIHOUJIANCHADEYOUGUANSHUJUYAOYOUJILUBINGBAOCUN。

4、WUJUNSHEBEIDEQINGXI,YOUQISHIZHIJIEJIECHUYAOPINDEBUWEIHEBUJIANBIXUMIEJUN,BINGBIAOMINGMIEJUNRIQI,BIYAOSHIYAOJINXINGWEISHENGWUXUEDEYANZHENG。JINGMIEJUNDESHEBEIYINGZAISANTIANNEISHIYONG。

顺发彩票投注 5、MOUXIEKEYIDONGDESHEBEIKEYIDAOQINGXIQUJINXINGQINGXI、XIAODUHEMIEJUN。

6、TONGYISHEBEILIANXUJIAGONGTONGYIWUJUNCHANPINSHI,MEIPIZHIJIANYAOQINGXIMIEJUN;TONGYISHEBEIJIAGONGTONGYIFEIMIEJUNCHANPINSHI,ZHISHAOMEIZHOUHUOMEISHENGCHANSANPIHOUJINXINGQUANMIANDEQINGXI。

(四)、 纯化水设备的安装要求

顺发彩票投注 SHEBEIDEANZHUANGYINGZUNXUNYIXIAYUANZE:

1、LIANDONGXIANHESHUANGFEISHIMIEJUNQIDENGJIAOXINSHISHEBEIDEANZHUANGKENENGYAOCHUANYUELIANGGEJIEJINGJIBIEBUTONGDEQUYUSHI,YINGZAIANZHUANGGUDINGDETONGSHI,CAIYONGSHIDANGDEMIFENGFANGSHI,BAOZHENGJIEJINGJIBIEGAODEQUYUBUSHOUYINGXIANG。

2、BUTONGJIEJINGDENGJIFANGJIANZHIJIAN,RUCAIYONGCHUANSONGDAICHUANDIWULIAOSHI,WEIFANGZHIJIAOCHAWURAN,CHUANSONGDAIBUYICHUANYUEGEQIANG,ERYINGZAIGEQIANGLIANGBIANFENDUANCHUANSONG。DUISONGZHIWUJUNQUDECHUANSONGZHUANGZHIZEBIXUFENDUANCHUANSONG。

3、SHEJIHUOXUANYONGQINGBIAN、LINGQIAODECHUANSONGGONGJU,RUCHUANSONGDAI、XIAOCHE、LIUCAO、RUANJIEGUAN、MIBILIAODOUDENG,YIFUZHUSHEBEIZHIJIANDELIANJIE。

顺发彩票投注 4、DUICHUANDONGJIXIEDEANZHUANGYINGZENGJIAFANGZHEN、XIAOYINZHUANGZHI,GAISHANCAOZUOHUANJING,DONGTAICESHISHI,JIEJINGSHINEIZAOSHENGBUDECHAOGUO70dB。

顺发彩票投注 5、SHENGCHAN、JIAGONG、BAOZHUANGQINGMEISUDENGQIANGZHIMINXINGYAOWU、MOUXIEZAITIYAOWU、GAOHUOXING、YOUDUHAIYAOWUDESHENGCHANSHEBEIBIXUFENKAIZHUANYONG。

(五)、设备的维修与保养要求

顺发彩票投注 BIXUZHIDINGYIZHENGTAOSHEBEIQINGJIEYUWEIXIUDESHUMIANGUICHENG,QINEIRONGBAOKUO:

1 QINGJIEYUWEIXIUSHEBEIDEFUZEREN、SHISHIREN。

顺发彩票投注 2 QINGJIEYUBAOYANGDESHIJIANANPAIBIAO。

3 QINGJIE、BAOYANGYUWEIXIUZUOYEDEFANGFA、SUOXUSHEBEI、CAILIAO,BAOKUOBAOZHENGWEIXIUXIAOGUOSUOJINXINGDESHEBEICHAIXIEYUZUZHUANGGUOCHENGJILU。

顺发彩票投注 4 CHUQUQIANPIGONGZUOBIAOZHI。

5 FANGZHIYIQINGJIESHEBEIBEIWURANDEFANGFA。

6 JIANCHASHEBEIQINGJIECHENGDUHOUSHIYONGDEZHIDU。