CN101920168B - 带有传感器座的用后可弃的切向流动过滤衬垫 - Google Patents

带有传感器座的用后可弃的切向流动过滤衬垫 Download PDF

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CN101920168B
CN101920168B CN2010101977665A CN201010197766A CN101920168B CN 101920168 B CN101920168 B CN 101920168B CN 2010101977665 A CN2010101977665 A CN 2010101977665A CN 201010197766 A CN201010197766 A CN 201010197766A CN 101920168 B CN101920168 B CN 101920168B
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M·莫里斯賽
D·王
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Abstract

本申请涉及带有传感器座的用后可弃的切向流动过滤衬垫。提供了一种切向流动过滤装置，其中在过滤元件与顶部和底部保持器或歧管之间提供衬垫。衬垫合并了流动通道和入口端口和出口端口以及传感器座。衬垫由廉价材料形成且因此是单次使用后可弃的，使得与清洁常规歧管相比，丢弃它们更具成本效益。传感器座容纳可移除的传感器且隔离它与流体路径。

Description

带有传感器座的用后可弃的切向流动过滤衬垫
本申请要求享有在2009年5月29日提交的美国临时申请第61/217,323号的优先权，该申请的公开内容以引用的方式结合到本文中。
技术领域
本申请涉及带有传感器座的用后可弃的切向流动过滤衬垫。
背景技术
切向流动过滤(Tangential Flow Filtration，TFF)是一种基于大小或分子量差异使用膜来分离液体溶液或悬浮液中组分的分离过程。应用包括：蛋白质和其它生物分子(诸如，核苷酸、抗原和单克隆抗体)的浓缩、澄清和脱盐；缓冲液更换；过程开发；膜选择研究；预层析澄清以移除胶体粒子；诸如右旋糖和抗生素的小分子的热源去除；细胞培养基、溶菌产物、胶体悬浮液和病毒培养基的收获、洗涤或澄清；以及，样品制备。
在TFF中，待过滤的溶液或悬浮液以横流模式横穿膜表面。用于过滤的驱动力是跨膜压力，在用后可弃的TFF应用中通常利用蠕动泵来生成跨膜压力。滤液横穿膜表面的速度也控制过滤速率且帮助防止膜堵塞。由于TFF穿过膜表面再循环滞留物，膜玷污被最小化，维持高过滤速率且提高产品回收。
常规TFF装置由多个元件形成，包括泵、进料溶液储集器、过滤模块和用于连接这些元件的管道。在使用中，进料溶液自进料溶液储集器导向至过滤模块，而来自过滤模块的滞留物从过滤模块再循环到进料溶液储集器直到获得所希望的滞留物体积。膜夹于顶部和底部歧管或保持器之间，顶部和底部歧管或保持器用于提供准确的机械约束抵抗装置的内部液压，且也用于在装置内的多个流动路径分配过滤流。这些歧管或保持器通常由不锈钢制成且必须在每次使用之前进行清洁和验证，特别是在生物制药和其它卫生应用中。这是一种昂贵和耗时的过程。
在替换过滤介质时需要排除清洁和验证步骤的情况下，可使用用后可弃的衬垫来代替可再使用的不锈钢衬垫。衬垫合并了流动通道和入口端口与出口端口且隔离过程流体防止与TFF保持器接触，流动通道和入口端口与出口端口先前存在于歧管中。衬垫可由廉价材料制成且因此是单次使用后可弃的，使得与清洁常规歧管相比，丢弃它们是更具成本效益的。此外，衬垫可被预先消毒。为了在操作条件下提供充分的强度和刚度，衬垫可具有肋片的网格图案，肋片靠着保持器板以帮助防止衬垫在夹持力下扭转。
还希望将传感器合并于衬垫中，用于测量各种过程参数，诸如压力，而在替换过滤介质和/或衬垫时无须对传感器进行清洁或消毒。
发明内容
由本文所公开的实施例来克服现有技术的缺点，其包括切向过滤组件，切向过滤组件包括一或多个优选地用后可弃的衬垫，在用后可弃的衬垫中安置一或多个传感器。传感器与流体隔离且可从衬垫移除。因此，在使用之后，衬垫可被丢弃且传感器可再使用而无须对传感器进行清洁。
根据某些实施例，提供一种切向流动过滤装置，其中一或多个衬垫位于过滤元件与顶部和底部保持器或歧管之间。衬垫合并了流动通道和入口端口与出口端口，流动通道和入口端口与出口端口常规地存在于不锈钢歧管中。衬垫由廉价材料制成且因此在单次使用之后可丢弃，使得与清洁常规歧管相比，丢弃它们更具成本效益。此外，衬垫可被预先消毒。为了在操作条件下提供充分的强度和刚度，衬垫可具有肋状物网格图案，肋状物靠着保持器板以防止衬垫在夹持力下扭转。++  一或多个衬垫包括一或多个传感器端口或座(mount)用于将传感器可移除地固结到衬垫上。膜片安置于传感器与衬垫中的流体通路之间，隔离传感器部件避免与通路中的流体直接接触。传感器保持能感测通路中的流体压力，但膜片的存在防止传感器受到流体污染。
附图说明
图1是根据某些实施例的切向流动过滤组件的透视图；
图2是图1的组件的分解图；以及
图3是示出根据某些实施例的传感器和传感器端口的分解图。
具体实施方式
首先转至图1，其示出根据某些实施例的过滤装置10。该装置10包括顶部保持器板12和间隔开的底部保持器板13。保持器板12、13优选地由不锈钢制成且具有充分的刚性和耐用性以向组件提供抵抗内部操作液压(诸如50-60psi)的准确且有效的机械约束。孔口28设于保持器板12、13中和组件的每个层中，以容纳拉杆或螺纹销或螺栓14或其它夹持装置以将组件固定在一起。可设有间隔件(未图示)，且其被弹簧加载。在保持器板12、13中并不存在过滤流通路。
在组装状态，定位于保持器板12下方的是用后可弃的衬垫16。衬垫16优选地由适合于特定应用的廉价材料制成，这样的材料是特定测定(诸如制药测定)可接受的(且优选地是政府核准的)。合适构造材料包括塑料，诸如聚苯乙烯，优选地聚烯烃，诸如聚丙烯，聚乙烯和其共聚物与混合物。在强度和刚度方面，特别优选聚砜。衬垫16优选地模制成具有通路和开口。作为替代且较不优选地，其可通过磨削、钻进或其它这样的方法形成。
过滤元件20夹于衬垫16与第二用后可弃的衬垫22之间。过滤元件20可为单个膜，且优选地为多个堆叠的膜，诸如堆叠的超滤或微滤膜，最优选地以盒(cassette)的形式。尽管示出了单个膜盒，本领域技术人员应了解可使用多个盒。合适的盒以名称
Figure GSA00000139326400041
销售且可购自Millipore Corporation。
如在本领域中的常规情况的那样，衬垫22包括第一端口17A，一或多个子端口17C，第二端口17B以及一或多个子端口17D(图2)。取决于其在组件内的方位，端口17A用于引入进料或移除滞留物，端口17B用于移除渗透物，同时防止滤液与滞留物或进料掺混，如常规情况的那样。端口17A与一或多个子端口17C流体连通。端口17A与17C和最靠近它的传感器端口流体连通。端口17A也与盒(例如，
Figure GSA00000139326400042
盒)的进料端口流体连通。端口17B与一或多个子端口17D流体连通。端口17B仅与17D和盒的渗透物排放端口连通。端口17A和端口17B可位于衬垫的相对侧上以提供充分的间距且避免干扰其它组分。但是，在间距充分或者不发生干扰的情况下，它们可位于相同侧上。每个端口17A、17B与衬垫主体中的流动路径或通路流体连通，衬垫主体中的流动路径或通路与相应孔口连通以提供进料、滞留物或渗透物的流动，如常规情况的那样，从而限定装置内过滤流的多个流动路径。
通路可为渐缩形，随着它们远离相应端口行进而变窄，以在子端口17C和17D中的每一个处使压力正常化。
在某些实施例中，衬垫16、20之一或二者的一侧可包括多个相互接合的肋片。肋片向衬垫提供增强的刚度，且可在模制过程中形成。肋片(若存在)位于衬垫接触保持器板12或13的侧部上。肋片从衬垫的一侧向另一侧延伸，除了被端口中断的位置。在组装时，向过滤元件20与衬垫施加显著夹持力，且在衬垫16、22的平滑侧与过滤元件20之间发生密封。肋片有助于在本发明的过滤装置中有效地组装衬垫，在施加压力时密封接合，而无需在保持器板中具有相对应的凹槽来与肋片配合。因此，靠着衬垫网格的保持器板的相应表面可为平坦的，且无需特殊地设计成适合衬垫。
在某些实施例中，一或多个传感器，优选地两个传感器，诸如进料压力传感器50A和滞留物压力传感器50B，可移除地连接到用后可弃的衬垫中的一或多个中的座端口。出于说明目的，在衬垫22中示出两个端口30A、30B。该或该等端口30A、30B各定位成与流体路径连通，从而可测量流体路径中的流体特征(例如，压力)。膜或膜片40(诸如由PVDF或聚烯烃，优选地聚乙烯(例如)制成的膜片)例如定位于端口30A(或30B)上以在操作期间隔离流体路径中的流体与传感器部件。可使用O形环41或类似物将膜片40密封到端口。若需要，膜或膜片可永久地附连到端口。
在某些实施例中，使用膜片压缩螺母52将传感器附连到衬垫22上，如在图2和图3中最佳地看出的那样。螺母52在内部具有螺纹，内部螺纹对应于定位于传感器50A上的传感器压缩螺母51上的外部螺纹，使得传感器50A可拧到螺母52上。传感器压缩螺母51将传感器凸缘压缩到较大的膜片压缩螺母52内。螺母52还具有外部螺纹，外部螺纹对应于端口30B中的螺纹使得螺母52可拧入到该端口内。滑移垫圈53可位于压缩螺母52与膜片之间，如图所示。螺母52压缩O形环41、膜片40和垫圈53就位。本领域技术人员应了解的是，可使用其它手段来将传感器附连到座端口上，诸如压配到该端口内或者到固结到端口上的合适插口内，保持传感器就位的夹具或紧固件等。
在组装的条件，传感器的操作部分直接抵靠膜或膜片定位。膜或膜片由充分柔性材料制成使得其响应于压力偏转，保持连续且并不破裂或失去隔离传感器与流体路径的能力。膜或膜片可为半渗透性的或不可渗透的。其优选地为消毒级。
存在两个传感器50A、50B(一个测量进料压力且另一个测量滞留物压力)允许计算跨膜压力，因为跨膜压力是进料压力与滞留物压力的平均值减去滤液压力。可以本领域技术人员熟知的常规方式来确定滤液压力。在使用中，可移除的传感器优选地与控制单元电通信，控制单元可记录相关过程参数，诸如进料压力、滞留物压力、跨膜压力等且可相应地控制这些参数。
通过将传感器可移除地连接到根据本文所公开的实施例的用后可弃的衬垫上的座端口，传感器保持与流体路径隔离且可易于从衬垫移除且再使用，同时衬垫在使用后可丢弃。这得到快速且容易的系统设置。
端口30A和30B的长度使得优选地在传感器端口的膜片与待传感的流体所流经的管道之间存在很小或不存在分支(deadleg)。这确保了无流体损失或变得停滞。
合适的传感器包括机电传感器，这是由于成本、准确性、可靠性和可用性考虑。机电传感器包括结合到薄金属膜片的应变计。膜片的变形导致应变计的变形，向控制单元发送比例电信号。本领域技术人员应了解的是，也可利用通过不同技术操作的传感器。

Claims (4)

1.一种过滤设备，包括：
顶板；
底板，其与所述顶板间隔开；
过滤构件，其定位于所述顶板与所述底板之间；
至少一个用后可弃的衬垫，其定位于所述顶板与所述过滤构件之间，所述衬垫具有流体入口，流体出口，在所述衬垫内的至少一个流体路径，和与所述流体路径流体连通的至少一个传感器端口；
膜片，其密封到所述至少一个传感器端口上；以及
传感器，其可移除地连接到所述传感器端口上，用于通过所述膜片来感测所述至少一个流体路径中的压力，而无需接触所述流体路径中的流体。
2.根据权利要求1所述的过滤设备，其特征在于，所述衬垫还包括至少一个第二流体路径，第二传感器端口以及密封到所述第二传感器端口上的第二膜片，所述过滤设备还包括第二传感器，所述第二传感器可移除地连接到所述第二传感器端口上，用于通过所述第二膜片感测所述第二流体路径中的压力，而无需接触所述第二流体路径中的流体。
3.一种衬垫，其用于过滤设备且适于在保持器板与过滤元件之间密封，所述衬垫包括适于靠着所述过滤元件的平坦面和适于靠着所述保持器板的相对面，所述衬垫具有流体入口、流体出口、在所述衬垫内的至少一个流体路径以及与所述流体路径流体连通的至少一个传感器端口；
膜片，其密封到所述至少一个传感器端口上；以及
传感器，其可移除地连接到所述传感器端口上，用于通过所述膜片来感测所述至少一个流体路径中的压力，而无需接触所述流体路径中的流体。
4.根据权利要求3所述的衬垫，其特征在于还包括至少一个第二流体路径，第二传感器端口，密封到所述第二传感器端口上的第二膜片，以及第二传感器，所述第二传感器可移除地连接到所述第二传感器端口上，用于通过所述第二膜片来感测所述第二流体路径中的压力，而无需接触所述第二流体路径中的流体。
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