CN109890716A - 用于柔性容器的壳体 - Google Patents

用于柔性容器的壳体 Download PDF

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CN109890716A
CN109890716A CN201880003960.XA CN201880003960A CN109890716A CN 109890716 A CN109890716 A CN 109890716A CN 201880003960 A CN201880003960 A CN 201880003960A CN 109890716 A CN109890716 A CN 109890716A
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T·乌姆
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Abstract

本发明涉及一种用于运输液体、尤其是药剂的柔性容器(2)的壳体，所述壳体至少部分地衬有弹性泡沫(3、5)。

Description

用于柔性容器的壳体
技术领域
本发明涉及一种用于运输液体、尤其是药剂的柔性容器的壳体。除了药剂之外，也可通过在这种壳体中的柔性容器运输在(生物)制药生产过程中出现的其它液体。
背景技术
用于在壳体中运输药剂的柔性容器也被称为“一次性使用袋”。这大多发生在冷冻状态中，其中，柔性容器在冷冻之前被放置在壳体中，然后通过冷却该组合体来冷冻液体。
在冷冻时的体积膨胀(约8％)产生不可低估的压力作用到壳体和柔性容器上。这导致机械损坏的风险并因此导致机械容器的泄漏。
发明内容
本发明的任务在于相对于现有技术减小在冷冻时柔性容器和壳体的机械应力。
所述任务通过具有权利要求1特征的壳体来解决。
这通过弹性泡沫——换句话说通过至少一个弹性泡沫体——来解决，所述壳体衬有该弹性泡沫。该弹性泡沫尤其是可至少部分地、优选基本上完全补偿在冷冻时出现的、设置在壳体中的容器的体积膨胀。也请求保护一种包括根据本发明的壳体和设置在该壳体中的填充有液体、尤其是药剂的柔性容器的组合体。
此外，还请求保护根据本发明的壳体的用途，其中，将液体、尤其是药剂填充到柔性容器中，将已填充的容器设置在所述壳体中，并且通过冷却包括壳体和容器的组合体来冷冻液体。
可在柔性容器中运输的液体例如是蛋白质溶液、纯化的最终产物、抗体溶液和其它在制药生产周期中的高质量中间产物，当然还有药剂本身。
本发明的有利实施方式在从属权利要求中被定义。
一种优选实施方式可在于，所述泡沫在冰点以下随着温度的降低具有减小的弹性。也可规定，泡沫在温度在0℃和-30℃之间、优选在-5℃和-25℃之间并且特别优选在-10℃和-20℃之间时基本上硬化。这些措施可有助于使壳体中的柔性容器位于壳体中精确匹配的“床”中。由此通过更大的表面吸收所有作用在柔性容器和壳体上的力。从而即使不能未完全排除，也至少减少因夹紧等引起的损坏。
在一种特别优选的实施方式中，泡沫这样构造，使得硬化过程是可逆的。当组合体的温度在运输之后升高时，泡沫的弹性因此再次得到恢复，从而在从壳体取出容器时提供一定的保护以防柔性容器受到影响。此外，如果希望的话，基于可逆过程，壳体原则上可反复使用。
泡沫的硬化也可称为固化。在此不涉及在泡沫生产中的硬化，而是涉及在冷效应下弹性特性的变化。
在一种特别优选的实施方式中可规定，壳体这样衬有泡沫，使得当容器设置在壳体中时，容器——优选与可能的附件一起——完全被泡沫包围。因此不仅可更好地保护柔性容器也可更好地保护附件免受损坏。
由于用于这种柔性容器的附件常常具有不同的形状，因为其例如由可变形的软管等制成，因此在壳体中的泡沫块可以是有利的，其可(通过变形)容纳附件。
壳体可构造成大致直角六面体形。这例如可有助于简单地堆叠壳体。
也可能必须运输未完全填充的容器。在这种情况下，可使用附加泡沫层，从而在此情况下也为柔性容器提供填满壳体体积的“床”。
附图说明
本发明的其它优点和细节由附图和相关的附图说明给出。附图如下：
图1示出根据本发明的壳体和设置在其中的柔性容器的剖面侧视图；
图2示出其剖面俯视图。
具体实施方式
从图1和2可以看出，柔性容器2设置在壳体1内部。在此壳体1衬有泡沫3和泡沫块5。当冷冻在容器2内的液体时，容器2膨胀。该体积膨胀由泡沫3和泡沫块5吸收，从而在容器2和壳体1之间不产生或至少不显著产生张力。附件4、如软管和阀等在此设置在泡沫块5上方或内部，该泡沫块可通过其弹性或柔性来容纳它们。
在本实施例中，壳体1构造成完全封闭的。壳体1可由塑料和/或金属制成。在本实施例中，盖层相应由不锈钢制成并且侧壁由聚乙烯(具体而言：高密度聚乙烯，HDPE)制成。
通过壳体1的完全封闭的设计确保了对容器2的接近保护。理论上也可安装闭锁件或封印，从而可排除在运输过程中或在仓库中的操纵或至少使其可见。
优选可这样构造泡沫3，使得其在室温(和较低的负温度)下是相对易折和柔性的并且在更低的温度(-15℃及更冷)下硬化并包围设置在壳体1中的容器2并防止相对运动。如此被保护的容器2因此不能弯曲或压缩，因为防止了相对于壳体1的相对运动。从而可防止例如由塑料制成的容器2上的断裂和泄漏。
作为泡沫例如可使用所谓的粘弹性泡沫，其在一定负温度下硬化。
可例如通过接触冷却设备或循环空气冷却设备或以其它方式来冷冻包括壳体1和已填充的容器2的组合体。在接触冷却设备中，壳体1(也称为“壳”)的各端面靠置在冷却表面上。在循环空气冷却设备中，用冷却空气对壳体1进行扫气。
壳体1的各个面、尤其是端面(即顶面和底面)可由相对薄的材料、尤其是钢制成，以实现快速的热传导(或冷传导)。
如上所述，根据本发明的壳体1可反复使用，尤其是当这样构造泡沫3，使得其在低温下的硬化可逆时。当然，也可想到一次性使用壳体1。为此壳体1可易于拆卸，以便实施简单的回收措施。

Claims (12)

1.用于运输液体、尤其是药剂的柔性容器(2)的壳体，该壳体至少部分地衬有弹性泡沫(3、5)。
2.根据权利要求1所述的壳体，其特征在于，该壳体(1)这样衬有所述泡沫(3、5)，使得设置在该壳体(1)中的容器(2)的在冷冻时出现的体积膨胀至少部分地、优选基本上完全由所述泡沫(3、5)补偿。
3.根据前述权利要求中任一项所述的壳体，其特征在于，所述泡沫(3、5)在冰点以下随着温度的降低具有减小的弹性。
4.根据前述权利要求中任一项所述的壳体，其特征在于，所述泡沫(3、5)在温度在0℃和-30℃之间、优选在-5℃和-25℃之间并且特别优选在-10℃和-20℃之间时基本上硬化。
5.根据权利要求4所述的壳体，其特征在于，所述硬化的过程是可逆的。
6.根据前述权利要求中任一项所述的壳体，其特征在于，该壳体(1)这样衬有所述泡沫(3、5)，使得当所述容器(2)设置在该壳体(1)中时，所述容器(2)优选与可能的附件(4)一起完全被所述泡沫(3、5)包围。
7.根据权利要求6所述的壳体，其特征在于，在该壳体(1)中的泡沫块(5)设置用于容纳所述附件(4)。
8.根据前述权利要求中任一项所述的壳体，其特征在于，该壳体(1)构造成大致直角六面体形。
9.包括根据前述权利要求中任一项所述的壳体和设置在该壳体中的填充有液体、尤其是药剂的柔性容器(2)的组合体。
10.根据权利要求1至9中任一项所述的壳体的用途，其中，将液体、尤其是药剂填充到柔性容器(2)中，将已填充的容器(2)设置在所述壳体(1)中，并且通过冷却包括壳体(1)和容器(2)的组合体来冷冻所述液体。
11.根据权利要求10所述的用途，其特征在于，通过冷却包括壳体(1)和容器(2)的组合体来冷冻所述液体。
12.根据权利要求11所述的用途，其特征在于，当所述柔性容器(2)仅被填充其一部分容量时，在所述容器(2)中设置附加的至少一层泡沫(3、5)。
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AT600042017 2017-01-16
ATA60004/2017 2017-01-16
ATGM50100/2017U AT15857U1 (de) 2017-01-16 2017-05-24 Gehäuse für einen flexiblen Behälter
ATGM50100/2017 2017-05-24
PCT/AT2018/060010 WO2018129576A1 (de) 2017-01-16 2018-01-15 Gehäuse für einen flexiblen behälter

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EP3926277A1 (en) 2020-06-19 2021-12-22 Single Use Support GmbH Plate freezer
EP3964453A1 (en) 2020-09-02 2022-03-09 Single Use Support GmbH Container for receiving a bag, method and usage
EP4014947B1 (en) 2020-12-16 2024-07-10 Single Use Support GmbH Method for protecting tubing
EP4166884A1 (en) 2021-10-15 2023-04-19 Single Use Support GmbH Cooling plate and method for manufacturing a cooling plate
EP4169499A1 (en) 2021-10-19 2023-04-26 Single Use Support GmbH Method and device for cooling or heating bio-pharmaceutical fluids
CN114471754A (zh) * 2021-12-27 2022-05-13 利穗科技(苏州)有限公司 一种用于生物材料水溶液的容器

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CN109890716B (zh) 2022-04-26
US11207239B2 (en) 2021-12-28
DK3509956T3 (da) 2022-04-11
US20190224074A1 (en) 2019-07-25
EP3509956A1 (de) 2019-07-17
WO2018129576A1 (de) 2018-07-19
EP3509956B1 (de) 2022-03-09
US20230157928A1 (en) 2023-05-25
US11602487B2 (en) 2023-03-14

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