永汀環保純化(hua)水產(chan)水指標
  化學指標：符(fu)合中華人民(min)共和國藥典(dian)2015版制藥純(chun)化水要(yao)求
  衛(wei)生學檢(jian)查：微生物 100CFU/100ml
  內素 0.25EU/ml 電導(dao)率 ≤5.1μS/cm ( 25℃)   
2.設備基本技術特(te)征
        系統采(cai)(cai)用(yong)全自動控制(zhi)(同時(shi)亦(yi)可采(cai)(cai)用(yong)手動控制(zhi))，系統運行時(shi)可設(she)(she)定自動反(fan)(fan)(fan)(fan)(fan)洗(xi)、再生程序;一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)和(he)二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)設(she)(she)有(you)回(hui)流(liu)管(guan)(guan)道(dao)，反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)設(she)(she)備(bei)(bei)設(she)(she)有(you)化學清洗(xi)裝(zhuang)置和(he)消毒裝(zhuang)置;在(zai)一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)和(he)二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)間(jian)設(she)(she)有(you) PH調節裝(zhuang)置，以保(bao)(bao)證純(chun)化水設(she)(she)備(bei)(bei)產(chan)水電(dian)(dian)導(dao)(dao)率(lv)(lv)(lv)符(fu)合(he)藥(yao)典要求(qiu);二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)膜采(cai)(cai)用(yong)帶(dai)正電(dian)(dian)荷的抗污染反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)膜，以保(bao)(bao)證反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)設(she)(she)備(bei)(bei)能(neng)長期穩(wen)定運行;一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)管(guan)(guan)路采(cai)(cai)用(yong) 304不(bu)銹鋼材(cai)(cai)料，二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)采(cai)(cai)用(yong) 316L 不(bu)銹鋼材(cai)(cai)料;在(zai)第(di)(di)一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)和(he)第(di)(di)二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)設(she)(she)備(bei)(bei)中(zhong)均裝(zhuang)有(you)在(zai)線電(dian)(dian)導(dao)(dao)檢測儀(yi)表，產(chan)水電(dian)(dian)導(dao)(dao)率(lv)(lv)(lv)可隨(sui)時(shi)觀看;一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)前設(she)(she)有(you)低壓保(bao)(bao)護開(kai)(kai)關(guan)，二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)前設(she)(she)有(you)低壓保(bao)(bao)護和(he)高壓保(bao)(bao)護開(kai)(kai)關(guan);一級(ji)(ji)(ji)(ji)(ji)、二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)水回(hui)收率(lv)(lv)(lv)可調整(zheng)一級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)回(hui)收率(lv)(lv)(lv) 70%-75%，二(er)級(ji)(ji)(ji)(ji)(ji)反(fan)(fan)(fan)(fan)(fan)滲(shen)(shen)(shen)(shen)(shen)透(tou)(tou)回(hui)收率(lv)(lv)(lv)85%;設(she)(she)備(bei)(bei)間(jian)管(guan)(guan)路采(cai)(cai)用(yong)SUS304管(guan)(guan)材(cai)(cai)。純(chun)化水儲水罐帶(dai)呼吸(xi)過濾器，輸(shu)送管(guan)(guan)道(dao)裝(zhuang)有(you)紫(zi)外線殺菌(jun)器和(he)微孔過濾器，保(bao)(bao)證純(chun)水符(fu)合(he)衛(wei)生要求(qiu)。   
3.設(she)備設(she)計(ji)、生(sheng)產(chan)、安裝和(he)運行符合GMP認證要求   
(1)結構設計應(ying)簡單、可靠、拆裝簡便。
  (2)為便于拆裝、更換、清(qing)洗零件，執行機構(gou)的(de)設計盡量(liang)采(cai)用的(de)標準化、通用化、系(xi)統(tong)化零部件。
  (3)設備內外(wai)壁表面(mian)，要求(qiu)光滑平整、無死角，容易清洗、滅(mie)菌。零件表面(mian)應做鍍(du)鉻等表面(mian)處理，以耐腐蝕，防止生銹。設備外(wai)面(mian)避(bi)免用(yong)油漆(qi)，以防剝(bo)落(luo)。
  (4)制(zhi)備(bei)(bei)純(chun)化水設(she)(she)備(bei)(bei)應采(cai)用低碳不銹(xiu)鋼或其他(ta)經驗證不污染水質的材料(liao)。制(zhi)備(bei)(bei)純(chun)化水的設(she)(she)備(bei)(bei)應定(ding)期清洗，并對清洗效(xiao)果驗證。   
(5)注射用水接觸(chu)的材料(liao)必須是(shi)優質低碳不銹鋼或其他(ta)經驗證(zheng)不對(dui)水質產生污染的 材料(liao)。制備(bei)注射用水的設備(bei)應定期清(qing)洗，并(bing)對(dui)清(qing)洗效果驗證(zheng)。
  (6)純化水儲(chu)(chu)(chu)存周(zhou)期(qi)不(bu)宜(yi)大于24小時(shi)，其(qi)(qi)儲(chu)(chu)(chu)罐(guan)宜(yi)采用(yong)不(bu)銹(xiu)鋼材(cai)料(liao)或經驗(yan)(yan)證(zheng)無毒，耐腐蝕，不(bu)滲出污(wu)染(ran)離子的其(qi)(qi)他材(cai)料(liao)制作。保護(hu)其(qi)(qi)通氣口應安裝不(bu)脫落纖(xian)維的疏(shu)水性除菌(jun)(jun)濾器。儲(chu)(chu)(chu)罐(guan)內壁應光(guang)滑，接管(guan)和(he)焊縫不(bu)應有死角和(he)沙(sha)眼。應采用(yong)不(bu)會形成滯(zhi)水污(wu)染(ran)的顯示(shi)液面、溫度(du)壓力等(deng)參數的傳(chuan)感器。對儲(chu)(chu)(chu)罐(guan)要定(ding)期(qi)清洗、消(xiao)毒滅菌(jun)(jun)，并對清洗、滅菌(jun)(jun)效果驗(yan)(yan)證(zheng)。   
(7)制藥用水的輸(shu)送(song)
  1)純化(hua)水(shui)(shui)和(he)制藥(yao)用(yong)水(shui)(shui)宜采用(yong)易(yi)拆卸清洗、消毒的(de)不銹鋼(gang)泵輸送(song)(song)。在需用(yong)壓縮(suo)空氣(qi)或氮氣(qi)壓送(song)(song)的(de)純 化(hua)水(shui)(shui)和(he)注射(she)用(yong)水(shui)(shui)的(de)場合，壓縮(suo)空氣(qi)和(he)氮氣(qi)須凈(jing)化(hua)處(chu)理。
  2)純化水(shui)宜采用(yong)循環(huan)管(guan)路輸(shu)(shu)送。管(guan)路設計應簡(jian)潔，應避免盲管(guan)和死角。管(guan)路應采用(yong)不(bu)銹鋼(gang)管(guan)或經驗(yan)證無毒、耐腐蝕、不(bu)滲出(chu)污染離子的(de)其他管(guan)材(cai)。閥門宜采用(yong)無死角的(de)衛生級(ji)閥門，輸(shu)(shu)送純化水(shui)應標明流(liu)向。
  3)輸送(song)純化水和注(zhu)射(she)用水的管道(dao)、輸送(song)泵應定期清洗、消毒滅菌，驗證合(he)格后方可投(tou)入使用