CN1196265A - 低温无菌氮系统 - Google Patents

低温无菌氮系统 Download PDF

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CN1196265A
CN1196265A CN98107758A CN98107758A CN1196265A CN 1196265 A CN1196265 A CN 1196265A CN 98107758 A CN98107758 A CN 98107758A CN 98107758 A CN98107758 A CN 98107758A CN 1196265 A CN1196265 A CN 1196265A
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nitrogen
steam
produce
aseptic
liquid
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CN1110325C (zh
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A·T·Y陈
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Praxair Technology Inc
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Abstract

一种制取低温无菌氮的系统,其中液氮首先被蒸发并随之在无菌前被加热,热的无菌氮蒸气被冷却以产生液氮蒸气,并最终将冷却的无菌氮冷凝制取低温无菌氮产品。本系统还可以用于制取其他低温无菌流体。

Description

低温无菌氮系统
本发明涉及例如无菌氮气类的低温流体的制取方法。通过本发明制取的其他无菌低温流体可以包括无菌的氩气，二氧化碳，氧气，氦气以及氢气。
液氮广泛应用于对物品的冷却或冷冻。虽然冷却或冷冻结可通过间接的热交换进行，但包含将氮气和物品直接接触的直接热交换方式是最好的，因其将氮气的冷却传递到物品的效率更高。然而，有些情况下，例如对抗生素、疫苗类药物的制备，必须放弃对作为直接接触冷却剂的液氮的使用，除非是消过毒的，虽然细菌和其他微生物在液氮的致冷温度下没有活力，但当冷却或冻结过的物质在较高的温度下时，细菌和其他微生物又会变得有活性。
因此，本发明的一个目的在于，提供一种有益并具有一定效率的制取低温无菌氮气以及其他无菌低温流体的系统。
上述及其他目的，本领域技术人员通过阅读后面的内容将容易达到，根据本发明的一个方面，即：
一种制取低温无菌氮气的方法，包括：
(A)蒸发液氮，以制取冷的氮蒸气；
(B)加热冷的氮蒸气，以制取热的氮蒸气；
(C)对热的氮蒸气无菌，以制取无菌的热的氮蒸气；
(D)通过与所述蒸发液氮的间接热交换，冷却无菌的热的氮蒸气以制取冷的无菌氮蒸气；以及
(E)冷凝冷的无菌氮蒸气以制取低温无菌氮产品。
本发明的其他方面是：
制取低温无菌流体的装置，包括：
(A)一个蒸发器以及用于将液态低温流体通入蒸发器的装置；
(B)一个加热器以及用于将液体从蒸发器通入加热器的装置；
(C)一个生物过滤器以及用于将液体从加热器通入生物过滤器的装置；
(D)一个冷凝器，用于将液体从生物过滤器通入蒸发器的装置，以及用于将液体从蒸发器通入冷凝器的装置；以及
(E)从冷凝结器获得低温无菌流体的装置。
在此所使用的“间接热交换”概念，意思是两种液流在没有物理接触或相互混合时的热交换关系。
在此所使用的“低温”概念，意思是它具有等于或低于-70℃的温度。
在此所使用的“无菌”概念，意思是不含有直径大于0.2微米的生物介质。
在此所使用的“生物过滤器”概念，意思是它具有直径不大于0.2微米小孔的过滤器。
仅有的一幅附图表示本发明制取低温无菌流体的一个实施例的简图。
从商业性考虑，最大量使用的低温无菌流体就是无菌氮。
因此，本发明将根据附图并结合一种无菌氮制品进行详细描述。根据附图，液氮1由诸如储罐类的液氮源(未示出)通过导管装置导向第一热交换器或设置于冷却箱3中的蒸发器2。液氮1的氮浓度至少具有60摩尔百分比，最好具有至少95摩尔百分比，并且绝对压力通常为每平方英寸16到250磅，在大约-160℃的温度或更低温度的绝对压力的每平方英寸250磅。冷却箱3是一个绝热容器，最好还容纳有第二热交换器或冷凝器4。
在蒸发器2内，液氮进行蒸发以制取通常具有温度为-160到-195℃及每平方英寸250磅的绝对压力的冷氮蒸气5。冷氮蒸气5被导入加热器6，加热到至少-50℃，通常为-20到30℃的温度，以制取热氮蒸气7。热氮蒸气温度最好为周围环境温度。热氮蒸气温度应超过过滤器模制材料的脆裂温度和玻璃状相变温度。
热氮蒸气7进入生物过滤器，在其中被灭菌制取无菌的热氮蒸气。图示的本发明实施例中，蒸汽8用于灭菌，氮气流被导入包含四个生物过滤器10的单元9并生成无菌的热氮蒸气11。
开始生产无菌氮之前，蒸汽8以至少110℃的温度供应到生物过滤器，并穿过生物过滤器数个小时以灭菌单元9及所有伴随的通道。之后，停止蒸汽供应，并通入诸如氮气类的气体24至48小时以将系统干燥。系统完全干燥后，用前述方法制备热氮蒸气，并使之穿过一层或多层生物过滤器而形成无菌氮蒸气。
热的无菌氮蒸气11通过导管从生物过滤器单元9的生物过滤器导向蒸发器2，使热的无菌氮蒸气所含的热量通过间接热交换用于蒸发如前所述的液氮，以制取冷氮蒸气5。在热交换过程中，热的无菌氮蒸气被冷却，制取通常为-157到-193℃温度的冷的无菌氮蒸气。
冷的无菌氮蒸气12从蒸发器2导向冷凝器4。如果需要，如图中所示，可以在冷的无菌氮蒸气从蒸发器2流向凝结器4的导管上连接排放管13，以去除凝结的蒸汽。在冷凝器4中，冷的无菌氮蒸气通过间接热交换制取作为产品的低温无菌氮14。低温无菌氮产品可以全部或部分直接用于冷却和/或冷冻，或全部或部分地作为储备使用。图示实施例作为优选实施例，其中液氮1的一部分15通过阀门16减低压力，作为流体19流向凝结器4中进行蒸发，以完成对前述冷的无菌氮蒸气的冷凝。之后，气态氮17从凝结器4中被排出。当使用流体15时，将导向蒸发器2的部分液氮流体看成流体18。
下面的表格概要地列出了本发明的一种例子，其中液氮流体看成流体液氮以850磅/小时(常温常压下11,902立方英尺/小时)的速率制取。该例子作为本发明实施例，与附图所示的相似，且简表中的流体数量也与附图中的相对应。该例子作为说明，但并不局限于此。
                                           流量
                 入口      出口    差值    英尺3/小时    大约能耗
                                           常温常压      (KW)流体                 18        5               11,902        23.9温度(C)              -176.5    -137    39.5压力(磅/英寸2)      75        70      -5形态                 液态氮    气态氮流体                 5         7               11,902        19.9温度(C)              -137      26.8    163.8压力(磅/英寸2)      70        70      0形态                 气态氮    气态氮流体                 7         11              11,902温度(C)              26.8      26.8    0压力(磅/英寸2)      70        60      -10形态                 气态氮    气态氮流体                 11        12      -       11,902        -23.9温度(C)              26.8      -173.5  -200.3压力(磅/英寸2)      60        55      -5形态                 气态氮    气态氮流体                 12        14              11,902        20.4温度(C)              -173.5    -180.7  -7.2压力(磅/英寸2)      55        50      -5形态                 气态氮    气态氮流体                 19        17              12,131        20.4温度(C)              -184.3    -185.5  1.2压力(磅/英寸2)      33        28      -5形态                 液态氮    气态氮
至此，利用本发明便可有效地制取低温无菌氮。虽然本发明已根据某一优选实施例进行了详细描述，本领域技术人员可以认可在本权利要求的实质及范围内的其他实施例。例如，如以上所讨论的，可以通过本发明制取其他低温无菌流体。可以认为，制备低温无菌流体，例如无菌氮，可以是百分之百纯度的氮，或是包含低于百分之百低温流体的混合物。本发明一般方法的严格定义如下：
一种制取低温无菌流体的方法包括：
(A)蒸发低温液体，以制取冷的蒸气；
(B)加热冷的蒸气，以制取热的无菌蒸气；
(C)对热的蒸气灭菌，以制取无菌的热的蒸气；
(D)通过与所述蒸发低温液体的间接热交换，冷却热的无菌蒸气以制取冷的无菌蒸气；以及
(E)冷凝冷的无菌蒸气以制取低温无菌产品。

Claims (10)

1.一种制取低温无菌流体的方法包括：
(A)蒸发液氮，以制取冷的氮蒸气；
(B)加热冷的氮蒸气，以制取热的氮蒸气；
(C)对热的氮蒸气灭菌，以制取无菌的热的氮蒸气；
(D)通过与所述蒸发液氮的间接热交换，冷却热的无菌氮蒸气以制取冷的无菌氮蒸气；以及
(E)冷凝冷的无菌氮蒸气以制取低温无菌氮产品。
2.根据权利要求1所述方法，进一步包括，向热的氮蒸气加入流体对热的氮蒸气进行无菌，以制取无菌的热的氮蒸气。
3.根据权利要求1所述方法，其特征在于，冷却消毒氮蒸气通过与低于其压力的液氮间接热交换进行冷凝。
4.根据权利要求1所述方法，其特征在于，热的氮蒸气是穿过生物过滤器进行无菌的。
5.制取低温无菌流体的装置，包括：
(A)一个蒸发器以及用于将液态低温流体通入蒸发器的装置；
(B)一个加热器以及用于将液体从蒸发器通入加热器的装置；
(C)一个生物过滤器以及用于将液体从加热器通入生物过滤器的装置；
(D)一个冷凝器，用于将液体从生物过滤器通入蒸发器的装置，以及用于将液体从蒸发器通入冷凝器的装置；以及
(E)从冷凝结器获得低温无菌流体的装置。
6.根据权利要求5的装置，还包括向生物过滤器供给流体的装置。
7.根据权利要求5的装置，还包括用于向冷凝结器注入液氮的装置和从冷凝结器中抽出气态流体的装置。
8.一种制取低温无菌流体的方法，包括：
(A)蒸发低温液体，以制取冷的蒸气；
(B)加热冷的蒸气，以制取热的蒸气；
(C)对热的氮蒸气灭菌，以制取热的无菌蒸气；
(D)通过与所述蒸发低温液体的间接热交换，冷却热的无菌蒸气以制取冷的无菌蒸气；以及
(E)冷凝冷的无菌蒸气以制取低温无菌产品。
9.根据权利要求8的方法，其特征在于，低温流体包括氩。
10.根据权利要求8的方法，其特征在于，低温流体包括二氧化碳。
CN98107758A 1997-04-17 1998-03-30 低温无菌流体的制取方法及装置 Expired - Lifetime CN1110325C (zh)

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CN104642297A (zh) * 2013-11-21 2015-05-27 浙江星博生物科技有限公司 一种用于生物材料密封式冻存的液氮过滤装置
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CN111874879A (zh) * 2020-07-29 2020-11-03 四川海盛杰低温科技有限公司 一种集成式液氮净化装置

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CN104642297A (zh) * 2013-11-21 2015-05-27 浙江星博生物科技有限公司 一种用于生物材料密封式冻存的液氮过滤装置
CN107289733A (zh) * 2017-07-18 2017-10-24 佛山市鼎特机械设备有限公司 一种无菌液氮机及其制氮工艺流程
CN111874879A (zh) * 2020-07-29 2020-11-03 四川海盛杰低温科技有限公司 一种集成式液氮净化装置

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