純化水巴(ba)氏消(xiao)(xiao)毒，萬邦德制藥就是(shi)選擇(ze)這種方法(fa)消(xiao)(xiao)毒，滅(mie)菌消(xiao)(xiao)毒是(shi)很有必要的(de)，巴(ba)士消(xiao)(xiao)毒是(shi)常見的(de)一種消(xiao)(xiao)毒方法(fa)。
一、滅菌與(yu)消毒概念
制藥純化水設備系統(tong)的(de)(de)滅菌是(shi)以化學(xue)劑(ji)或(huo)者(zhe)物(wu)理方法(fa)消滅所(suo)有活的(de)(de)微(wei)(wei)生物(wu)，包括所(suo)有細菌的(de)(de)繁殖(zhi)體、芽孢、真菌及病(bing)(bing)毒，從(cong)而達到(dao)完全無(wu)菌的(de)(de)過程。而消毒是(shi)用物(wu)理或(huo)者(zhe)化學(xue)方法(fa)或(huo)清除(chu)傳播媒(mei)介上(shang)的(de)(de)病(bing)(bing)原微(wei)(wei)生物(wu)，使其達到(dao)無(wu)害(hai)化。
二、巴(ba)氏消毒
在制藥純化(hua)水(shui)(shui)(shui)(shui)設(she)備(bei)系(xi)(xi)(xi)統(tong)(tong)中，巴(ba)氏消(xiao)(xiao)毒的主要(yao)作用是(shi)：用于純化(hua)水(shui)(shui)(shui)(shui)系(xi)(xi)(xi)統(tong)(tong)中的活性(xing)炭(tan)等預(yu)處理(li)單(dan)元的周(zhou)期性(xing)消(xiao)(xiao)毒，RO反滲(shen)透、EDI模(mo)塊的周(zhou)期性(xing)消(xiao)(xiao)毒以(yi)及純化(hua)水(shui)(shui)(shui)(shui)儲存與分(fen)配管路的周(zhou)期性(xing)消(xiao)(xiao)毒;用于注射用水(shui)(shui)(shui)(shui)系(xi)(xi)(xi)統(tong)(tong)正常(chang)(chang)運(yun)行時(shi)的微生(sheng)物抑制。經過巴(ba)氏消(xiao)(xiao)毒后的純化(hua)水(shui)(shui)(shui)(shui)設(she)備(bei)系(xi)(xi)(xi)統(tong)(tong)仍然有(you)小部分(fen)無害(hai)或者有(you)益、較耐熱的細菌，同時(shi)消(xiao)(xiao)毒操作時(shi)間(jian)相(xiang)對較長，常(chang)(chang)采(cai)用80℃以(yi)上的熱水(shui)(shui)(shui)(shui)循環一兩個小時(shi)才能完成巴(ba)氏消(xiao)(xiao)毒。優點是(shi)可以(yi)有(you)效的控制純化(hua)水(shui)(shui)(shui)(shui)系(xi)(xi)(xi)統(tong)(tong)中的微生(sheng)物污(wu)染水(shui)(shui)(shui)(shui)平在50CFU/ml，并(bing)且可以(yi)控制純化(hua)水(shui)(shui)(shui)(shui)設(she)備(bei)系(xi)(xi)(xi)統(tong)(tong)的內毒素在5EU/ml的水(shui)(shui)(shui)(shui)平。
三、制藥(yao)用水的要求
制(zhi)藥(yao)(yao)用(yong)水(shui)(shui)(shui)通常(chang)指制(zhi)藥(yao)(yao)工藝過程中用(yong)到的各種質(zhi)量標準(zhun)的水(shui)(shui)(shui)，根據應用(yong)范圍劃分(fen)為飲用(yong)水(shui)(shui)(shui)、純化(hua)水(shui)(shui)(shui)、注射用(yong)水(shui)(shui)(shui)、滅菌注射用(yong)水(shui)(shui)(shui)。飲用(yong)水(shui)(shui)(shui)主(zhu)要用(yong)于中藥(yao)(yao)生產，純化(hua)水(shui)(shui)(shui)、注射用(yong)水(shui)(shui)(shui)和(he)滅菌注射用(yong)水(shui)(shui)(shui)的主(zhu)要區別(bie)為電(dian)導率、細菌內(nei)毒素和(he)微生物限度的指標不(bu)同。藥(yao)(yao)品(pin)生產中，用(yong)水(shui)(shui)(shui)的水(shui)(shui)(shui)質(zhi)直接關系(xi)到產品(pin)的質(zhi)量。所以制(zhi)藥(yao)(yao)企業對水(shui)(shui)(shui)系(xi)統的設計、安裝、驗證、運行和(he)維(wei)護的各個環(huan)節都非常(chang)重(zhong)(zhong)視，為了(le)生產出符合質(zhi)量標準(zhun)的水(shui)(shui)(shui)，還需(xu)要不(bu)斷(duan)地進行水(shui)(shui)(shui)質(zhi)監測(ce)。在歷次藥(yao)(yao)品(pin)GM臉查中，水(shui)(shui)(shui)系(xi)統往往也(ye)是檢(jian)查的重(zhong)(zhong)點。
