CN1945098B - 具有增强混合的液体分配系统 - Google Patents
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Abstract
本发明公开了一种分配悬浮液或乳液的分配装置和系统。所述系统通过使流体流动例如利用连续或蠕动流并穿过分配匣来确保连续相流体中分散相分布的均匀度。在一个实施例中,将几个蠕动泵放置在所述分配匣的上游和下游,与流体源流体连通,并且与所述流体源形成单独的环路。在所述流体源与所述分配匣之间保持循环。在第二个实施例中,泵将流体泵入和泵出所述分配匣,并且也与流体源流体连通,例如通过夹紧式阀,以允许从所述流体源对所述分配匣进行适当的注入。在第三个实施例中,在所述分配匣与流体源之间放置反向泵,以将流体频繁地或连续地泵入和泵出所述分配匣。
Description
技术领域
目前有各种各样类型的将肠外和眼科用制品注入小瓶和容器中的分配装置。其中之一是容积式灌装机。这些装置采用圆筒和活塞布置,而这种布置与液体接触并将液体进行分配。具有代表性的是液体进入圆筒,此时活塞在向上运动,并产生真空,液体通过入口进入这个真空之中。该活塞的向下运动将液体通过出口排出。然后可重复这个过程。容积式灌装机还有其它具体形式,如那些利用旋转泵的形式。
背景技术
虽然这些灌装机由于其灌装速度和精度而受到普遍欢迎,但其用途有限,尤其是在制药领域。这些装置在清洁时非常困难,通常在消毒时必须得拆开。而且,由于这种装置实际上与液体接触,所以经常有受到污染的危险。
另一种类型的分配装置是时间/压力灌装机。这种类型中具有代表性的灌装机包括保持在常压的液体室。液体通过排出管道进行分配,该排出管道由夹紧式阀所控制。这种夹紧式阀在精确的时间段内开启以分配液体。由于压力保持恒定,而且时间间隔也是恒定的,所以所分配的液体量也应是恒定的。不过,由于设备随着时间的变化以及该排出管随着时间的变形,这些系统就不会像在许多用途中所要求的那样精确了。
分配装置的第三种类型是像在美国专利5,680,960和5,480,063以及美国专利公开No.2005-0029301中所说明的容量分配装置,这些专利通过引用结合于本文中。这些装置测量并分配预定体积的液体。
由于这些系统没有与该液体接触的移动部件,所以它们的精确度高并且能够避免容积式装置所常见的污染问题。
前述装置均可用于分配单相液体,但在分配分散在液体中的固体(悬浮液)或者悬浮在另一种液体中的液体滴(乳液)时,所述所有装置均有一种或多种重大缺陷。悬浮液制品,如疫苗,或者甾类化合物制品在摇晃并不彻底时会发生沉淀。在乳液的情况下,当摇晃两种液体时,这两种液体会形成液滴,而在摇晃停止时这些液滴可分成两个单独的层。这两种情况中的任何一种都会在制品从一个小瓶到下一个小瓶的最终分配期间导致含量不均。
此外,盛放过悬浮液或乳液的处理设备难以进行清洁,这样的结果是花费大量的劳动力进行清洁,并且需要很长的停工时间来从一个批次转到另一个批次。由于最终的药物制品必须保持无菌,所以必须在重新组装分配装置时进行严格的无菌处理。
因此,本发明的一个目的在于提供一种分配系统,这种系统设有将悬浮液和乳液制品进行混合的装置,而能够保持系统的完整性,以使无菌状态不受到负面影响。本发明的另一个目的在于减少花在对输送系统进行清洁上的时间,从而减少清洁所要求的停工时间。
发明内容
本发明克服了现有技术中所存在的问题,并且提供一种新颖的分配匣(cartridge),这种分配匣适于安装到分配悬浮液或乳液的主装置中。这种液体分配匣尤其适于以单用途形式制造,这种单用途形式包括贮液器和注入管组件,特别是包括贮液器、管道、接头和连接器以及针头。该系统通过利用如连续流或脉动流使液体流动并穿过该贮液器来确保液体的均匀度。
在一个实施例中,将几个蠕动泵或其它非侵入式泵装置放置在所述贮液器的上游和下游,这些蠕动泵或非侵入式泵装置与充分混合的流体源流体连通,并与充分混合的流体源形成单独的环路。在所述液体源与贮液器之间保持循环,以确保所述贮液器中恒定的液体水平。
在第二个实施例中,蠕动泵或其它非侵入式泵装置使液体进行循环并穿过所述贮液器。充分混合的液体源通过第二泵或夹紧式阀将液体输送到所述再循环管道,以保持所述贮液器中适当的液体水平。
在第三个实施例中,在所述贮液器与液体源之间放置反向泵,以周期性地或连续地从所述贮液器将液体泵入或泵出。
所述单用途形式允许便利安装和预消毒,也易于进行清洁,这样就会导致最低限度的停工时间和清洁用化学制品成本的大大降低,并且能够在较大程度上确保无菌状态。所述贮液器的形状和材料对于保持制品的均匀度至关重要。
附图说明
图1是示出分配匣的一个实施例的示意图;
图2是示出根据本发明的分配系统的第一个实施例的示意图;
图3是示出根据本发明的分配系统的第二个实施例的示意图;
图4是示出根据本发明的分配系统的第三个实施例的示意图;以及
图5是示出贮液器的实施例的示意图。
具体实施方式
本说明书中所描述的分配系统由单用途分配匣和硬件部件组成,所述分配匣可安装在所述硬件部件上。所述硬件系统在现有技术(美国专利5,680,960和5,480,063,这些专利通过引用结合于本文中)中已有描述。本发明提供了一种新颖的能够使悬浮液或乳液精确分配的分配匣和方法。
优选所述分配匣的贮液器部分是一种易弯曲的或者柔韧的室或囊,该贮液器能够膨胀和收缩,以保持恒定的内部压力。一次性像袋子一样的室特别适合于用作这种贮液器。所述分配匣的管道部分由诸如硅树脂、聚乙烯或者其它弹性体或聚合物为基础的管材组成,所述管道与塑料连接器缚在一起,这些塑料连接器由诸如聚乙烯、聚丙烯或聚氟碳这样的材料制成。
图1示出了分配匣的一个实施例。贮液器20上的入口21和出口22由管状环路15连接在一起。提供贮液器20底部上的端口25,以允许液体流动到管道组件,该管道组件用于将制品输送到其最终容器(未示出)。
图2示出了根据本发明的一个实施例的单环路分配系统。该系统包括进给泵1和抽取泵2,所述进给泵1与充分混合的整体液体供应源4以及与所述分配匣3的贮液器的入口或注入端口流体连通,所述抽取泵2与所述分配匣3的贮液器的出口和所述充分混合的整体液体供应源4的进给口流体连通。构造所述进给泵1和所述抽取泵2以将所述分配匣3与所述再循环管道中的流体柱的重量或压力隔离。可使用任何类型的非侵入式泵装置,但蠕动泵在制药用途中特别有好处,因为流体并不与泵的任何部件接触,而且不必使用密封和阀门。
可以使用诸如光学传感器或电容传感器这样的液位传感器(硬件系统的一部分,未示出),来监测所述分配匣3中贮液器的液位,因此也可以对所述泵的速度进行控制,以保持恒定的液位。或者可以使用液位开关,在这种情况下,可以用开/关的方式对所述的这些泵进行控制。例如,一个泵可连续地打开,但慢于另一个断续地打开的泵。不管这些泵的相对运行,这两个泵中的任何一个都不关闭一段时间是很重要的,这个时间段足以使所述悬浮液或乳液中足够的固体分离,以至于所述制品超出分散相含量的规范范围(即“最长分离时间”)。
图3示出了本发明的第二个实施例,在该实施例中,采用循环环路方案来保持穿过所述分配匣3的流量。非侵入式泵5,如蠕动泵,使所述制品进行循环并穿过管状环路15,所述管状环路15与所述分配匣3的贮液器的入口和出口流体连通。因此,泵5的进入口与所述分配匣3的贮液器的出口流体连通,且泵5的排出口与所述分配匣3的贮液器的入口流体连通。优选所述泵5在所述系统的运行期间连续打开,以保持所述流体处于运动状态。
管状环路15由长度相对较短的适当的管道18连接到充分混合的整体液体供应源4,所述管道18穿过阀门6,所述阀门6可以是一种夹紧式阀。优选所述阀门6受控,以对所述分配匣3中贮液器的液位做出响应,该液位可用液位传感器来确定。
这种构造要求位于传递点的所述充分混合的整体液体供应源4中的压力大于所述阀门6的另一侧的压力。这可以以任何数量的方式来实现,如通过利用重力来实现,这种重力通过提升所述充分混合的整体液体供应源4或者向所述充分混合的整体液体供应源加压或者在所述阀门6的贮液器一侧采用一种与所述贮液器再循环环路成直线的文丘里管限制来产生。为了避免所述传递管道18中的相位分离,在打开时允许在所述整体液体供应源4与所述管状环路15之间进行流体连通的阀门应经常打开。传递阀6的一种适当选择是非侵入式泵,如蠕动泵。
图4示出了本发明的再一个实施例,在该实施例中,采用一种交替或反向泵,以保持所述贮液器中的流量和混合。能够将方向反转的单蠕动泵8通过适当的管道与所述整体液体供应源4和所述分配匣3的贮液器流体连通。对所述分配匣3的贮液器的液位进行监测,如利用液位开关。当所述贮液器的液位达到预定的水平时,所述泵8保持打开,但将方向交替,以将制品周期性地或连续地交替泵入和泵出所述贮液器。如果所述分配匣3的贮液器的液位下降到低于所述预定的水平,将所述泵8以单向模式放置,以将所述贮液器加注到所希望的水平,然后再将所述泵8以交替模式放置,以将制品交替泵入和泵出所述贮液器,以保持流量并避免固体的沉淀。
在流体从所述分配匣3的贮液器排出并不像将其注入所述贮液器时那样将所述贮液器中的制品有效地混合的情况下,所述泵8的速度也可与泵的方向一致进行交替,以使该泵排出流体的时间少于该泵循环时间的50%或者可将所述循环时间减少。
图5示出了所述分配匣的贮液器20部分的一个优选实施例。所述优选实施例设计用于提升所述贮液器20中的流体运动并减少任何可能的滞流区。该实施例示出了位于所述贮液器20相对侧上的所述贮液器20的入口21和出口22。所述贮液器20的底部上的端口25允许液体流动到管道组件,该管道组件用于将制品输送到其最终容器(未示出)。
本领域熟练的技术人员会理解,虽然以上的说明详细地描述了管道的用途,但其它类型的流体管道也是可以接受的,包括适当的导管、管路等。此外,本领域熟练的技术人员还会理解所述分配匣贮液器可利用的多种构造以及所述循环环路可利用的多种构造。
Claims (29)
1.一种用于分配预定体积的流体的流体分配装置,所述装置包括贮液器、第一泵、第二泵和用于确定所述贮液器中的流体液位的流体液位确定装置,所述第一泵与包括两相流体的流体源和所述贮液器流体连通,以将所述两相流体泵入所述贮液器,所述第二泵与所述贮液器和所述流体源流体连通,以将所述两相流体泵出所述贮液器,
其中,对所确定的流体液位作出响应,所述第一泵和第二泵在所述流体源和所述贮液器之间保持循环,以确保所述贮液器中的恒定的液位水平,并且使得所述两相流体保持均匀度。
2.如权利要求1所述的流体分配装置,其特征在于:所述第一泵和第二泵是蠕动泵。
3.如权利要求1所述的流体分配装置,其特征在于:所述流体是悬浮液。
4.如权利要求1所述的流体分配装置,其特征在于:所述流体是乳液。
5.如权利要求1所述的流体分配装置,其特征在于:还包括控制器,所述控制器对所述流体液位确定装置做出响应,以在所述贮液器中液位的基础上控制所述第一和第二泵的速度。
6.如权利要求1所述的流体分配装置,其特征在于:还包括容纳所述贮液器的分配匣。
7.一种用于分配预定体积的流体的流体分配装置,所述装置包括具有入口和出口的贮液器、具有进入口和排出口的泵和对从流体源向所述泵进入口流动的流体量进行调节以保持流量的装置,所述泵的进入口与所述贮液器的所述出口流体连通,且所述泵的排出口与所述贮液器的所述入口流体连通。
8.如权利要求7所述的流体分配装置,其特征在于:所述流体是悬浮液。
9.如权利要求7所述的流体分配装置,其特征在于:所述流体是乳液。
10.如权利要求7所述的流体分配装置,其特征在于:所述对流体量进行调节的装置包括阀门。
11.如权利要求10所述的流体分配装置,其特征在于:所述阀门是夹紧式阀。
12.如权利要求7所述的流体分配装置,其特征在于:所述对流体量进行调节的装置包括泵。
13.如权利要求7所述的流体分配装置,其特征在于:对流入所述泵的进入口的流体量进行调节的所述装置对所述贮液器中的液位做出响应。
14.如权利要求7所述的流体分配装置,其特征在于:还包括容纳所述贮液器的分配匣。
15.一种用于分配预定体积的流体的流体分配装置,所述装置包括贮液器和反向泵,所述贮液器与流体源流体连通,所述反向泵与所述流体源和所述贮液器流体连通,以交替地将流体从所述流体源泵入所述贮液器和将流体从所述贮液器泵出到所述流体源。
16.如权利要求15所述的流体分配装置,其特征在于:所述泵是蠕动泵。
17.如权利要求15所述的流体分配装置,其特征在于:所述流体是悬浮液。
18.如权利要求15所述的流体分配装置,其特征在于:所述流体是乳液。
19.如权利要求15所述的流体分配装置,其特征在于:所述反向泵对所述贮液器中的液位做出响应,使得当所述液位达到预定的水平时,所述泵将方向交替。
20.如权利要求15所述的流体分配装置,其特征在于:还包括容纳所述贮液器的分配匣。
21.一种减少贮液器中两相流体的分离的方法,所述方法包括提供与所述贮液器流体连通的所述流体的供应源;确定所述贮液器中的所述流体的液位;用第一泵从所述源将所述流体泵到所述贮液器以及用第二泵从所述贮液器将所述流体泵到所述源,其中,对所确定的流体液位作出响应,所述第一泵和第二泵在所述流体源和所述贮液器之间保持循环,以确保所述贮液器中的恒定的液位水平,并且使得所述两相流体保持均匀度。
22.如权利要求21所述的方法,其特征在于:所述流体是悬浮液。
23.如权利要求21所述的方法,其特征在于:所述流体是乳液。
24.一种减少贮液器中两相流体的分离的方法,所述方法包括:提供所述流体的充分混合的整体供应源,通过将所述流体的一部分泵出所述贮液器的一侧和泵回所述贮液器的相反的另一侧而在所述贮液器中循环所述流体,以及,对与所述贮液器连通的所述充分混合的整体供应源中的所述流体的量进行调节以保持流量。
25.如权利要求24所述的方法,其特征在于:所述流体是悬浮液。
26.如权利要求24所述的方法,其特征在于:所述流体是乳液。
27.一种减少贮液器中两相流体的分离的方法,所述方法包括:提供与所述贮液器流体连通的所述流体的供应源,利用以第一方向运行的反向泵将所述流体从所述供应源泵送到所述贮液器,以及利用以第二方向运行的所述反向泵将所述流体从所述贮液器泵送到所述源。
28.如权利要求27所述的方法,其特征在于:所述流体是悬浮液。
29.如权利要求27所述的方法,其特征在于:所述流体是乳液。
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2006
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- 2006-07-14 EP EP06253702A patent/EP1750103B1/en not_active Not-in-force
- 2006-07-14 EP EP09152824A patent/EP2053368B1/en not_active Not-in-force
- 2006-07-14 ES ES06253702T patent/ES2373454T3/es active Active
- 2006-07-14 AT AT09151128T patent/ATE547694T1/de active
- 2006-07-14 AT AT06253702T patent/ATE530881T1/de not_active IP Right Cessation
- 2006-07-14 EP EP09151128A patent/EP2048481B1/en not_active Not-in-force
- 2006-07-14 ES ES09151128T patent/ES2382260T3/es active Active
- 2006-07-25 CN CN2006101085746A patent/CN1945098B/zh not_active Expired - Fee Related
-
2008
- 2008-09-16 US US12/283,797 patent/US8118191B2/en not_active Expired - Fee Related
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2011
- 2011-05-05 US US13/101,412 patent/US20110206540A1/en not_active Abandoned
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US20090014467A1 (en) | 2009-01-15 |
US7810674B2 (en) | 2010-10-12 |
US20070023449A1 (en) | 2007-02-01 |
EP2048481A1 (en) | 2009-04-15 |
EP2048481B1 (en) | 2012-02-29 |
CN1945098A (zh) | 2007-04-11 |
EP2053368B1 (en) | 2012-09-05 |
US8118191B2 (en) | 2012-02-21 |
EP2053368A1 (en) | 2009-04-29 |
ES2392741T3 (es) | 2012-12-13 |
ES2382260T3 (es) | 2012-06-06 |
ES2373454T3 (es) | 2012-02-03 |
EP1750103A3 (en) | 2008-03-19 |
US20110206540A1 (en) | 2011-08-25 |
EP1750103A2 (en) | 2007-02-07 |
ATE530881T1 (de) | 2011-11-15 |
ATE547694T1 (de) | 2012-03-15 |
EP1750103B1 (en) | 2011-10-26 |
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