疫(yi)苗制劑(ji)凍幹(gan)機(ji)特(te)點(dian)及(ji)工(gong)藝(yi)過(guo)程

疫苗制劑(ji)做(zuo)凍(dong)幹(gan)要(yao)選擇適合(he)的(de)凍(dong)幹(gan)機(ji)，其凍幹機(ji)的(de)特(te)點(dian)：1.完(wan)整(zheng)的PAT控制技(ji)術(shu)，可對凍幹過(guo)程進行(xing)完(wan)整(zheng)的控制和(he)分(fen)析監(jian)控。包(bao)括(kuo)預(yu)凍(dong)全過(guo)程控制、預(yu)凍(dong)結(jie)束(shu)判(pan)定(ding)、升華(hua)全(quan)過(guo)程控制、升(sheng)華(hua)結(jie)束(shu)判(pan)定(ding)、解析全(quan)過(guo)程控制及(ji)凍(dong)幹(gan)結(jie)束(shu)判(pan)定(ding)。2.板(ban)層溫(wen)度均壹度±1℃。3.系統極(ji)限真(zhen)空(kong)度±1Pa。4，系統真(zhen)空(kong)泄(xie)露(lu)率＜3Pa.L/S。5.外界(jie)幹擾熱量(liang)屏蔽(bi)。共(gong)晶點(dian)測(ce)試儀助(zhu)力(li)工(gong)藝(yi)開(kai)發(fa)。全進口配(pei)件(jian)。疫(yi)苗制劑(ji)的凍(dong)幹(gan)工藝(yi)過(guo)程：預凍(dong) ：將(jiang)疫苗原液分(fen)裝入凍(dong)幹(gan)瓶(ping)中(zhong)，凍(dong)幹(gan)瓶(ping)置(zhi)於(yu)凍(dong)幹機內，使其在零(ling)下 20℃中(zhong)預(yu)凍(dong) 4h，然(ran)後(hou)在-35℃中(zhong)預(yu)凍(dong) 2h；同(tong)時開(kai)啟(qi)真(zhen)空(kong)機(ji)，使(shi)凍幹機的真(zhen)空(kong)度維(wei)持在(zai)8pa~12pa。壹次(ci)幹燥 ：調(tiao)節(jie)隔板(ban)溫度，控制隔(ge)板(ban)溫度維(wei)持在(zai)-30℃ - - 28℃，真(zhen)空(kong)度維(wei)持在(zai)15Pa，保(bao)溫(wen) 10h；二次幹(gan)燥 ：調(tiao)節(jie)隔板(ban)溫度，維(wei)持在(zai)-28℃ -   - 25℃之間(jian)，真(zhen)空(kong)度維(wei)持在(zai) 15Pa，保(bao)溫(wen)15h。解析幹(gan)燥 ：隔板(ban)溫度升溫至 15℃，真(zhen)空(kong)度為 15Pa，維(wei)持 2h；然(ran)後(hou)將(jiang)隔板(ban)溫度升溫至30℃，真(zhen)空(kong)度為 10Pa，保(bao)溫(wen) 5h。疫苗制劑(ji)凍幹(gan)機(ji)Pilot5-8T：