CN111093720A - 具有蒸汽可穿过的密封件的无菌容器 - Google Patents
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Abstract
本发明涉及一种无菌容器(1),所述无菌容器具有容器槽(2)、容器罩盖(3)和用于封闭所述无菌容器的闭锁件,其中,在所述容器槽和所述容器罩盖之间设有密封件(4)或者密封元件并且所述密封件或所述密封元件是蒸汽可穿过的。
Description
技术领域
本发明涉及一种具有蒸汽可穿过的密封件的无菌容器以及与无菌容器一起使用的蒸汽可穿过的密封件。
背景技术
传统的无菌容器具有无菌容器槽、无菌容器罩盖和介质交换系统。所述介质交换系统尤其用于交换液态和/或气态的介质、例如水蒸汽并且可设计为过滤器、阀等。因此,所述介质交换系统也用于在所述无菌容器内部和外部环境之间的压力平衡。所述无菌容器槽和所述无菌容器罩盖经由密封件/密封元件彼此连接。所述密封元件用于使在所述无菌容器槽和所述无菌容器罩盖之间的间隙相对于否则会经过该间隙的流体密封,并因此将所述无菌容器的内部与外界隔离。所述闭锁件构造在所述槽上、所述罩盖上、这二者上或与所述无菌容器分开/单独地构造。通常使用硅酮圆线或硅酮唇形密封件作为密封件/密封元件。可为阀或过滤器系统或二者组合的介质交换系统通常布置在所述槽中或所述罩盖中。
传统的无菌容器的密封件/密封元件会受到磨损。尤其发泡的硅酮圆线在其使用寿命期间变脆并且失去复位力,因此在每次使用无菌容器之前必须对所述密封件/密封元件进行光控。此外在每次使用所述无菌容器之前,除了所述密封件/密封元件之外,也必须通过相当复杂的光控检查所述无菌容器的介质交换系统是否完好无损以及具有功能性。
因此,本发明的目的是提供一种无菌容器,其中仅需简短的/简单的光控。
发明内容
本发明通过将密封件/密封元件以及介质交换系统的功能集成或组合在一个构件中实现了该目的。换句话说本发明在于组合所述密封件/密封元件和所述介质交换系统。在已知的无菌容器中所述介质交换系统和所述密封元件或所述密封件作为两个单独构件位于所述容器槽和所述容器罩盖之间。
因此,简化了根据本发明的无菌容器的构造并且代替两个构件、即密封件/密封元件和介质交换系统仅需对一个构件进行光控,在该构件中结合了所述密封件/密封元件以及所述介质交换系统的功能。因此,可在根据本发明的无菌容器中取消例如呈过滤器或阀形式的介质交换系统。因此,根据本发明的无菌容器可设计为无阀或无过滤器的。
具体而言,该目的通过根据权利要求1所述的具有蒸汽可穿过的密封件/密封元件的无菌容器或者通过根据权利要求9所述的与无菌容器一起使用的蒸汽可穿过的密封件/密封元件实现。
优选地,所述蒸汽可穿过的密封件/密封元件可选择地或者仅可使水蒸汽通过。此外,可穿透性仅可为单向的。
所述蒸汽可穿过的密封件优选布置在所述容器罩盖和所述容器槽之间。该布置的优点是,良好地保护在所述容器罩盖和所述容器槽之间的蒸汽可穿过的密封件/密封元件以免不期望的损坏。传统的无菌容器的传统介质交换系统在没有设置额外遮盖部、顶罩等时大多可从上部接触到所述容器罩盖并因此会轻易受到损坏。
但是原则上也可使所述容器罩盖和/或所述容器槽至少局部地设有蒸汽可穿过的密封件。因此,所述蒸汽可穿过的密封件也可集成到所述容器罩盖中和/或所述容器槽中,例如作为由蒸汽可穿过的密封件材料的窗口类型,该密封件材料被引入所述容器槽或所述容器罩盖的壁区段中。但是在这种情况下在所述容器槽和所述容器罩盖之间的间隙中需要普通的密封件。
根据本发明的一种方案,所述蒸汽可穿过的密封件/密封元件形成微生物屏障并且同时允许可在所述容器内部和所述容器外部之间发生气体交换。通过所述微生物屏障也可在较长时间上确保所述无菌容器中的无菌产物的无菌性。在存储和运输期间与杀菌器之外的气体交换的可能性尤为重要,从而能够使容器内部空间和容器外部之间实现压力平衡。
根据本发明的另一方案,所述蒸汽可穿过的密封件设计为一次性构件。这具有的额外优点是,在重新使用所述无菌容器之前无需通过光控检查所述蒸汽可穿过的密封件/密封元件是否完好无损或者是否具有功能性。因此进一步简化或缩短了光控。
可替代地,所述蒸汽可穿过的密封件也可设计为可重复利用构件/永久构件。在这种情况下虽然在重新利用无菌容器之前必须通过光控检查所述蒸汽可穿过的密封件是否完好无损或具有功能性,但是由于密封件/密封元件和介质交换系统的功能集成取消了单独的介质交换系统的必要性,从而相比于传统的无菌容器仅需以光学方式检查一个构件(所述蒸汽可穿过的密封件/密封元件),而不是检查两个构件(密封件/密封元件和介质交换系统)。
根据本发明的另一方案,所述蒸汽可穿过的密封件/密封元件由多孔的材料、优选由多孔的聚四氟乙烯(PTFE)制成。该多孔的材料尤其适用于可重复的方案。
尤其在一次性方案中,所述密封元件例如也可由聚丙烯无纺布和无菌纸制成。线绳、垫圈等也可为合适的,只要材料保持无菌的条件。
因此根据本发明的另一方案,所述蒸汽可穿过的密封件构造成线绳、垫圈、纺织物、针织编织物或无纺布。
根据本发明的另一方案,所述蒸汽可穿过的密封件构造成密封唇,所述密封唇设计为在所述无菌容器内部为低压时通过弹性变形打开用于压力平衡的通口,优选打开在所述容器槽和所述容器罩盖之间的间隙。在这种情况下如此选择密封唇的唇部几何结构,使得在所述无菌容器内部中的低压为预定阈值时打开所述密封唇,以使所述容器槽和所述容器罩盖之间实现压力平衡。
根据本发明的另一方案,所述无菌容器的所述闭锁件可弹性地被支承。即使在所述无菌容器内部中的压力显著变化时也可实现足够的压力平衡。在所述无菌容器的内部过压很高的情况下所述容器罩盖会弹性地偏移。
本发明的另一方案涉及蒸汽可穿过的密封件/密封元件,所述蒸汽可穿过的密封件/密封元件设计成,与无菌容器一起使用。例如可为现有的传统的无菌容器配备这种蒸汽可穿过的密封件/密封元件。
根据本发明的一种方案,这种蒸汽可穿过的密封件/密封元件形成微生物屏障。
优选地,所述蒸汽可穿过的密封件/密封元件设计为一次性构件/可重复利用构件。但是,所述蒸汽可穿过的密封件/密封元件也可为可重复利用构件/永久构件。
根据本发明的蒸汽可穿过的密封件/密封元件优选由多孔的材料、优选由多孔的聚四氟乙烯制成。
根据本发明的蒸汽可穿过的密封件/密封元件优选构造成线绳、垫圈、纺织物、针织编织物或无纺布。
根据本发明的蒸汽可穿过的密封件/密封元件还可设计为密封唇,根据压力差、尤其在达到特定低压时所述密封唇以先前特定方式变形。
附图说明
在图1中示出了本发明的可能的设计方案。附图仅用于示意性表示。
具体实施方式
如在图1中所示,无菌容器1具有容器槽2和容器罩盖3。未示出闭锁件,所述闭锁件可构造在所述容器罩盖上、所述容器槽上、所述二者上或独立地且与所述无菌容器分开地构造。所述槽和罩盖的几何结构是任意的。
在示出的分解示意图中示出了蒸汽可穿过的密封件4,所述密封件4布置在所述容器槽2和所述容器罩盖3之间。如果将所述无菌容器组合,则所述蒸汽可穿过的密封件4齐平地位于所述容器罩盖3和所述容器槽4之间并且密封在这两个部件之间的间隙。
为了在杀菌器中发生显著的压力变化期间也能够有足够的压力平衡(如果仅经由密封件不足以实现平衡),可弹性地支承闭锁件,以便在容器中发生过压时可使所述罩盖抬起。
为了即使在所述容器中为低压时也能够使得压力平衡,所述密封件可构造成唇部几何结构的形式,其中,在所述容器中为低压时唇部“翻开”并且打开间隙,经由所述间隙可实现压力平衡。所述密封件例如可构造成线绳、垫圈、纺织物、针织编织物和无纺布的形式。
本发明的核心在于,在一构件中组合了介质交换系统和密封件、优选在无菌容器中组合蒸汽可穿过的密封件/密封元件,可作为一次性产品或可重复利用。
在一次性产品中取消了否则构造为永久产品的密封件的光控。此外取消了介质交换系统的所有组件。
在构造成重复利用产品时取消了介质交换系统的所有组件,但是必须在所述组合的构件上、优选所述蒸汽可穿过的密封件/密封元件上进行光控。
Claims (11)
1.一种无菌容器,所述无菌容器具有容器槽、容器罩盖和用于封闭所述无菌容器的闭锁件,
其中,在所述容器槽和所述容器罩盖之间设有密封件以相对于外界密封所述无菌容器的内部,其特征在于,
在所述容器槽和所述容器罩盖之间的所述密封件可选地为蒸汽可穿过的。
2.根据权利要求1所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件可选地为水蒸汽可穿过的。
3.根据权利要求1或2所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件形成微生物屏障。
4.根据前述权利要求中任意一项所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件是一次性构件。
5.根据前述权利要求中任意一项所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件由多孔的材料、优选由多孔的聚四氟乙烯制成。
6.根据前述权利要求中任意一项所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件构造成线绳、垫圈、纺织物、针织编织物或无纺布。
7.根据前述权利要求中任意一项所述的无菌容器,其特征在于,
所述蒸汽可穿过的密封件构造成密封唇,所述密封唇设计为在所述无菌容器内部为低压时通过弹性变形打开用于压力平衡的通口,优选打开在所述容器槽和所述容器罩盖之间的间隙。
8.根据前述权利要求中任意一项所述的无菌容器,其特征在于,
所述闭锁件能弹性地被支承。
9.一种蒸汽可穿过的密封件,所述蒸汽可穿过的密封件设计成,与根据前述权利要求中任意一项所述的无菌容器一起使用。
10.根据权利要求9所述的蒸汽可穿过的密封件,其特征在于,
所述蒸汽可穿过的密封件可选地为水蒸汽可穿过的。
11.根据前述权利要求中任意一项所述的蒸汽可穿过的密封件,其特征在于,可选地其他的灭菌介质,优选过氧化氢、环氧乙烷、臭氧和/或甲醛能穿过所述蒸汽可穿过的密封件。
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