制藥行業的容器密封完整性檢測

近年來(lai)，無菌(jun)制劑容器針(zhen)對密封完(wan)(wan)整性的(de)檢(jian)測越來(lai)越嚴格(ge)，日(ri)本藥(yao)(yao)局(ju)方(fang)JPTI2016、美國藥(yao)(yao)典USP1207、美國材(cai)料試驗學(xue)會(hui)ASTM F2338-09及中國無菌(jun)藥(yao)(yao)品(pin)GMP檢(jian)查指南(nan)都明(ming)確提到了無菌(jun)藥(yao)(yao)品(pin)容器的(de)密封完(wan)(wan)整性檢(jian)查。其中，USP1207詳細闡(chan)述(shu)了真(zhen)空衰減法(fa)。與行業傳統的(de)色水法(fa)、微生物挑戰法(fa)相比，真(zhen)空衰減法(fa)具有無損、定量、精(jing)度高(gao)、可溯源等優點。

真空衰(shuai)減(jian)法(fa)又分(fen)為(wei)直壓(ya)法(fa)、差壓(ya)法(fa)。我(wo)們(men)推薦(jian)差壓(ya)檢漏方(fang)法(fa)，其基本(ben)原(yuan)理(li)是(shi)：

將(jiang)被檢(jian)無(wu)(wu)菌(jun)制(zhi)劑容(rong)(rong)(rong)器(qi)(qi)(qi)與(yu)基準物(wu)，放(fang)入(ru)差壓(ya)(ya)(ya)(ya)(ya)式檢(jian)漏(lou)(lou)儀(yi)的(de)(de)兩個密閉容(rong)(rong)(rong)器(qi)(qi)(qi)內。檢(jian)測(ce)時，先對密閉容(rong)(rong)(rong)器(qi)(qi)(qi)抽真空(kong)，然后進(jin)行(xing)(xing)保(bao)壓(ya)(ya)(ya)(ya)(ya)，若(ruo)被檢(jian)無(wu)(wu)菌(jun)制(zhi)劑容(rong)(rong)(rong)器(qi)(qi)(qi)存(cun)在小(xiao)漏(lou)(lou)，放(fang)置(zhi)被檢(jian)無(wu)(wu)菌(jun)制(zhi)劑容(rong)(rong)(rong)器(qi)(qi)(qi)的(de)(de)密閉容(rong)(rong)(rong)器(qi)(qi)(qi)內的(de)(de)壓(ya)(ya)(ya)(ya)(ya)力(li)會(hui)發生(sheng)變化(hua)，檢(jian)漏(lou)(lou)儀(yi)上的(de)(de)差壓(ya)(ya)(ya)(ya)(ya)傳感器(qi)(qi)(qi)即可(ke)檢(jian)出。若(ruo)被檢(jian)容(rong)(rong)(rong)器(qi)(qi)(qi)存(cun)在大(da)(da)(da)漏(lou)(lou)，在對密閉容(rong)(rong)(rong)器(qi)(qi)(qi)抽真空(kong)時，被檢(jian)容(rong)(rong)(rong)器(qi)(qi)(qi)內的(de)(de)壓(ya)(ya)(ya)(ya)(ya)力(li)與(yu)密閉容(rong)(rong)(rong)器(qi)(qi)(qi)內的(de)(de)壓(ya)(ya)(ya)(ya)(ya)力(li)會(hui)同時升高，進(jin)行(xing)(xing)保(bao)壓(ya)(ya)(ya)(ya)(ya)時，放(fang)置(zhi)被檢(jian)容(rong)(rong)(rong)器(qi)(qi)(qi)的(de)(de)密閉容(rong)(rong)(rong)器(qi)(qi)(qi)內的(de)(de)壓(ya)(ya)(ya)(ya)(ya)力(li)不(bu)會(hui)發生(sheng)變化(hua)，檢(jian)漏(lou)(lou)儀(yi)上的(de)(de)差壓(ya)(ya)(ya)(ya)(ya)傳感器(qi)(qi)(qi)沒(mei)有大(da)(da)(da)漏(lou)(lou)顯示，此時檢(jian)漏(lou)(lou)儀(yi)進(jin)行(xing)(xing)第(di)二步程序，采用配容(rong)(rong)(rong)分壓(ya)(ya)(ya)(ya)(ya)的(de)(de)方式，進(jin)行(xing)(xing)大(da)(da)(da)漏(lou)(lou)率(lv)檢(jian)測(ce)。通過前后兩步檢(jian)測(ce)，檢(jian)漏(lou)(lou)儀(yi)將(jiang)會(hui)給出被檢(jian)無(wu)(wu)菌(jun)制(zhi)劑容(rong)(rong)(rong)器(qi)(qi)(qi)的(de)(de)漏(lou)(lou)率(lv)數值。

測(ce)試步驟： 抽真空、保壓(ya)、小(xiao)泄漏檢測(ce)、大泄漏檢測(ce)、排氣