在(zai)(zai)藥(yao)品(pin)生產過(guo)程中(zhong)(zhong)中(zhong)(zhong)，制藥(yao)配(pei)料(liao)(liao)工藝系(xi)統(tong)、在(zai)(zai)線清(qing)洗系(xi)統(tong)與(yu)在(zai)(zai)線消毒/滅菌系(xi)統(tong)是整個藥(yao)品(pin)生產環節中(zhong)(zhong)的核(he)心組(zu)成部分。單(dan)元操(cao)作是系(xi)統(tong)組(zu)成的要素，在(zai)(zai)制藥(yao)生產工藝中(zhong)(zhong)，核(he)心的單(dan)元操(cao)作主要有投料(liao)(liao)、攪(jiao)拌(ban)、混(hun)合、加熱(re)、冷卻、輸(shu)送(song)、離心、萃取(qu)、結晶(jing)、過(guo)濾、灌裝等。制藥(yao)配(pei)液(ye)系(xi)統(tong)中(zhong)(zhong)的攪(jiao)拌(ban)技術分為不(bu)銹鋼攪(jiao)拌(ban)技術與(yu)一次性攪(jiao)拌(ban)技術兩大(da)類。

不銹(xiu)鋼攪拌系統廣(guang)泛應(ying)用(yong)金(jin)屬合金(jin)類材料，在(zai)(zai)(zai)制(zhi)(zhi)藥(yao)(yao)領域(yu)被用(yong)于混(hun)(hun)勻同質化液(ye)體和固體。大致可(ke)以分(fen)為液(ye)/液(ye)混(hun)(hun)合與固/液(ye)混(hun)(hun)合兩種常規應(ying)用(yong)。隨著時間推移(yi)，不銹(xiu)鋼配液(ye)系統在(zai)(zai)(zai)制(zhi)(zhi)藥(yao)(yao)工(gong)藝中的(de)運用(yong)越(yue)(yue)來越(yue)(yue)廣(guang)泛，也越(yue)(yue)來也自動化，從早(zao)期(qi)的(de)手工(gong)配料、半(ban)自動配料到現在(zai)(zai)(zai)的(de)智能化配制(zhi)(zhi)，操作體積(ji)從原(yuan)來的(de)幾(ji)升(sheng)(sheng)(sheng)到幾(ji)十升(sheng)(sheng)(sheng)，現在(zai)(zai)(zai)可(ke)高達幾(ji)萬升(sheng)(sheng)(sheng)甚至更(geng)高；使用(yong)范圍覆蓋化學(xue)藥(yao)(yao)、中藥(yao)(yao)及(ji)生物(wu)制(zhi)(zhi)品(pin)等。

一(yi)次性(xing)(xing)攪拌技術在(zai)制藥(yao)(yao)領域被(bei)用于(yu)混(hun)勻同質化(hua)液體和(he)固體。大(da)致可(ke)以分為液/液混(hun)合(he)，固/液混(hun)合(he)和(he)固/固混(hun)合(he)三種應用。隨著時間推(tui)移，一(yi)次性(xing)(xing)使(shi)用的(de)(de)混(hun)合(he)系統在(zai)無菌制藥(yao)(yao)下游(you)工藝(yi)中的(de)(de)運(yun)用越(yue)來(lai)越(yue)廣泛：操(cao)作體積(ji)從(cong)原(yuan)來(lai)的(de)(de)幾十升(sheng)到(dao)幾百升(sheng)，現在(zai)可(ke)高達幾千升(sheng)；使(shi)用范圍覆蓋化(hua)藥(yao)(yao)，蛋白藥(yao)(yao)物到(dao)疫苗；運(yun)用到(dao)的(de)(de)工藝(yi)點(dian)也從(cong)原(yuan)來(lai)的(de)(de)無菌制劑向前推(tui)進到(dao)中間體儲存調(diao)節，下游(you)病(bing)毒滅活等的(de)(de)關(guan)鍵步驟(zou)。因為在(zai)運(yun)用點(dian)上(shang)更(geng)趨向接近(jin)于(yu)產品(pin)的(de)(de)最終(zhong)劑型，或關(guan)鍵工藝(yi)點(dian)，所以對一(yi)次性(xing)(xing)攪拌袋的(de)(de)完整性(xing)(xing)，顆粒釋放(fang)，溶(rong)出析出物更(geng)為敏感。

根據一次性攪拌系統的攪拌模式，至少可以分為(wei)5大類：

1

搖擺式攪拌：

波(bo)(bo)浪(lang)式攪(jiao)拌(ban)(ban)系統由一次性枕(zhen)型(xing)袋和(he)搖(yao)擺(bai)平臺組(zu)成。一次性枕(zhen)型(xing)袋充入液(ye)體后(hou)放置于搖(yao)擺(bai)平臺上，液(ye)體通過搖(yao)擺(bai)平臺的(de)(de)有規律搖(yao)擺(bai)形成前(qian)后(hou)或軌道運(yun)動(dong)，在液(ye)體表面形成波(bo)(bo)浪(lang)從而達到混(hun)(hun)合效果。搖(yao)擺(bai)的(de)(de)角度(du)(du)和(he)頻率決定(ding)了產生波(bo)(bo)浪(lang)的(de)(de)大(da)小和(he)速度(du)(du)。攪(jiao)拌(ban)(ban)混(hun)(hun)合的(de)(de)效果取(qu)決于搖(yao)擺(bai)的(de)(de)強度(du)(du)和(he)混(hun)(hun)合的(de)(de)時間。該類攪(jiao)拌(ban)(ban)一般(ban)適用于液(ye)/液(ye)混(hun)(hun)合的(de)(de)模(mo)式。

2

機(ji)械軸攪拌：

機(ji)(ji)械軸攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)又分為上攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)和(he)底(di)(di)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)兩種模式。它(ta)們都(dou)是(shi)通過電機(ji)(ji)驅(qu)動(dong)(dong)機(ji)(ji)械軸轉動(dong)(dong)或(huo)擺動(dong)(dong)，從而(er)使用槳(jiang)葉或(huo)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)棒在3D形(xing)(xing)狀的(de)(de)(de)(de)一(yi)次性攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋內對液(ye)/液(ye)或(huo)固(gu)/液(ye)進(jin)行(xing)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)混勻(yun)。該3D的(de)(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋需要一(yi)定(ding)固(gu)定(ding)形(xing)(xing)狀的(de)(de)(de)(de)容器做支(zhi)撐（一(yi)般為圓筒型(xing)或(huo)立(li)方體型(xing)），以保證攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋的(de)(de)(de)(de)形(xing)(xing)狀和(he)對抗袋子內部的(de)(de)(de)(de)水壓。常規(gui)的(de)(de)(de)(de)機(ji)(ji)械軸上攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)是(shi)在3D攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋的(de)(de)(de)(de)頂(ding)部安(an)裝一(yi)次性的(de)(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)或(huo)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)棒，或(huo)者使用可(ke)重復使用的(de)(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)/棒，但是(shi)將它(ta)們置于(yu)一(yi)個(ge)硅膠內管封閉(bi)的(de)(de)(de)(de)套筒內使它(ta)們不與料液(ye)發生接觸。機(ji)(ji)械軸底(di)(di)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)的(de)(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)置于(yu)一(yi)次性攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋的(de)(de)(de)(de)底(di)(di)部，相(xiang)對于(yu)上攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)模式，底(di)(di)攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系統(tong)受處理(li)液(ye)體液(ye)面高度的(de)(de)(de)(de)限制較小，但是(shi)對機(ji)(ji)械軸封閉(bi)要求(qiu)比較高。攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)效(xiao)果(guo)主要取決于(yu)槳(jiang)葉的(de)(de)(de)(de)形(xing)(xing)狀，尺寸，轉速(su)等(deng)綜合(he)參數，由于(yu)是(shi)電機(ji)(ji)驅(qu)動(dong)(dong)，所以一(yi)般情(qing)況輸出功率越(yue)大，攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)效(xiao)果(guo)越(yue)好(hao)。可(ke)運用于(yu)粘稠難攪(jiao)(jiao)(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)的(de)(de)(de)(de)料液(ye)混勻(yun)。

3

磁力攪拌：

磁(ci)(ci)力(li)(li)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)是一次性(xing)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)最常用(yong)的(de)(de)(de)模(mo)(mo)式(shi)。通(tong)過(guo)電(dian)磁(ci)(ci)力(li)(li)驅動(dong)在(zai)(zai)3D攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋(dai)(dai)底部的(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)葉轉(zhuan)動(dong)，從(cong)而達到(dao)液(ye)(ye)(ye)/液(ye)(ye)(ye)或固(gu)/液(ye)(ye)(ye)的(de)(de)(de)混(hun)(hun)勻(yun)(yun)效果。磁(ci)(ci)力(li)(li)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)一次性(xing)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)內(nei)置于(yu)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋(dai)(dai)內(nei)，可分為磁(ci)(ci)軸(zhou)承(cheng)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)和(he)(he)磁(ci)(ci)懸(xuan)浮(fu)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)這兩大類。磁(ci)(ci)軸(zhou)承(cheng)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)葉和(he)(he)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋(dai)(dai)底部由惰性(xing)軸(zhou)承(cheng)相連接(jie)，槳(jiang)葉轉(zhuan)動(dong)起(qi)來(lai)不與(yu)袋(dai)(dai)子內(nei)部膜(mo)材(cai)發生接(jie)觸。而磁(ci)(ci)懸(xuan)浮(fu)系(xi)(xi)(xi)統(tong)(tong)采用(yong)的(de)(de)(de)是超導驅動(dong)，一旦(dan)形(xing)成穩(wen)定磁(ci)(ci)場后(hou)，攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)懸(xuan)浮(fu)并旋轉(zhuan)進行攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)混(hun)(hun)勻(yun)(yun)。磁(ci)(ci)懸(xuan)浮(fu)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)在(zai)(zai)袋(dai)(dai)內(nei)無軸(zhou)承(cheng)和(he)(he)封條，因此無懸(xuan)浮(fu)葉槳(jiang)和(he)(he)袋(dai)(dai)子膜(mo)材(cai)質(zhi)或軸(zhou)承(cheng)之間的(de)(de)(de)摩(mo)擦，被(bei)公認為超凈(jing)的(de)(de)(de)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)系(xi)(xi)(xi)統(tong)(tong)。主(zhu)要(yao)被(bei)運(yun)用(yong)在(zai)(zai)制劑灌裝的(de)(de)(de)關鍵(jian)工(gong)藝(yi)點環(huan)節(jie)。與(yu)機械(xie)軸(zhou)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)一樣，3D磁(ci)(ci)力(li)(li)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋(dai)(dai)需要(yao)固(gu)定形(xing)狀(zhuang)的(de)(de)(de)容(rong)器做支(zhi)撐(cheng)。一般支(zhi)撐(cheng)容(rong)器為圓(yuan)筒(tong)型或立方體(ti)型。從(cong)混(hun)(hun)合效率來(lai)看，立方體(ti)的(de)(de)(de)支(zhi)撐(cheng)容(rong)器能帶來(lai)更好的(de)(de)(de)混(hun)(hun)合效率，因為立方體(ti)支(zhi)撐(cheng)容(rong)器的(de)(de)(de)四壁形(xing)成天然的(de)(de)(de)擋板，有助于(yu)打破層流擴大攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)范圍。如果配(pei)液(ye)(ye)(ye)系(xi)(xi)(xi)統(tong)(tong)采用(yong)圓(yuan)筒(tong)型的(de)(de)(de)支(zhi)撐(cheng)容(rong)器，大體(ti)積的(de)(de)(de)混(hun)(hun)合建議使用(yong)偏(pian)心模(mo)(mo)式(shi)，即攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)槳(jiang)在(zai)(zai)攪(jiao)(jiao)(jiao)(jiao)拌(ban)(ban)(ban)袋(dai)(dai)底部的(de)(de)(de)偏(pian)心位置。

4

循環(huan)式(shi)攪拌(ban)：

循(xun)環(huan)式(shi)攪(jiao)(jiao)拌分為外循(xun)環(huan)攪(jiao)(jiao)拌和內(nei)(nei)循(xun)環(huan)攪(jiao)(jiao)拌兩類。外循(xun)環(huan)是(shi)將(jiang)一(yi)(yi)次性袋子內(nei)(nei)的(de)料(liao)液(ye)通(tong)過蠕動泵抽(chou)出來(lai)通(tong)過外部管路再(zai)次循(xun)環(huan)進袋子內(nei)(nei)，經過多次再(zai)循(xun)環(huan)從到(dao)達到(dao)混勻的(de)效果。一(yi)(yi)般(ban)只適用于(yu)液(ye)/液(ye)混合(he)的(de)模式(shi)。而(er)內(nei)(nei)循(xun)環(huan)是(shi)在袋子底(di)部中集成一(yi)(yi)個(ge)磁力驅動渦(wo)輪，渦(wo)輪像離心泵一(yi)(yi)樣運轉，槳袋子內(nei)(nei)部的(de)液(ye)體垂直(zhi)抽(chou)下來(lai)再(zai)通(tong)過特別設計的(de)出口(kou)易水平方(fang)向(xiang)沿著底(di)部排(pai)出，沖向(xiang)袋子的(de)低角從而(er)轉向(xiang)沖擊到(dao)袋體的(de)頂部完整一(yi)(yi)個(ge)完整的(de)內(nei)(nei)部循(xun)環(huan)。袋子內(nei)(nei)部將(jiang)持續保持著這樣的(de)3D內(nei)(nei)部循(xun)環(huan)直(zhi)到(dao)料(liao)液(ye)混合(he)均勻。

5

震動混合攪拌：

震動混合器(qi)一(yi)般(ban)是(shi)由有3D支撐(cheng)的一(yi)次性(xing)袋子和一(yi)個集成(cheng)在袋子內部(bu)的軸承(cheng)及表面具有多個錐(zhui)形穿孔(kong)的碟片(pian)式(shi)槳(jiang)葉構成(cheng)。震動通(tong)過軸承(cheng)傳輸到(dao)碟片(pian)式(shi)槳(jiang)葉錐(zhui)形孔(kong)而(er)(er)產生伯努利效(xiao)應(ying),這種(zhong)振動導致液體(ti)通(tong)過錐(zhui)孔(kong)向上或向下出從而(er)(er)達到(dao)混合的效(xiao)果(guo)。該攪拌模式(shi)只(zhi)適用于低(di)粘稠度的液/液混合。