CN101449125B - 冷冻干燥器架 - Google Patents
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Abstract
冷冻干燥器架(10)包括相对的平行的第一和第二板(12、14),第一和第二板(12、14)具有位于其间至少一个流动槽(18),用于在板之间传送透热流体。板中的一个具有经过处理的表面,以在压力作用到橡胶塞子而将塞子推入容器中时,阻止挤压该表面的橡胶塞子与架粘黏。
Description
本发明涉及冷冻干燥器架,以及制造冷冻干燥器架的方法。
冷冻干燥器架位于冷冻干燥器的冷冻干燥室内,用于接纳包含将被冷冻干燥的制品的多个容器或小瓶。室通常包括数个架,架中的每一个可在室中升高或降低。要装载架,先使架落在室的下部中,而将最上面的架首先移动到装载位置。在最上面的架被装载后,机构自动地将所装载的架升高,以使下一个架能够移动到装载位置。该移动顺序继续,直到室装载完成。要卸载室,则使装载顺序反向,首先卸载最下面的架。
架还用于在例如乙醇、乙二醇或硅油的透热流体(diathermic fluid)和将被冷冻干燥的制品之间传递热。在冷冻干燥过程中,存在于制品中的水分被冷冻。外部制冷回路冷却在冷却干燥器架内循环的透热流体,以使热从制品传递到透热流体,并从而使制品内所包含的水分冷冻。在冷冻后,室被抽空到通常低于1毫巴(mbar),而透热流体被外部加热器加热,以使样品内的冰升华成水蒸气。
冷冻干燥器的架还通常用于将塞子(stopper)压入容器内。在冷冻干燥过程中,塞子松弛地定位在容器的口上,以使水蒸气能够从样品中升华。在冷冻干燥过程完成后,使架相对于彼此移动,以使位于一个架上的容器的塞子的上部表面接触位于其上的架的下部表面。架的持续的相对移动将塞子压入容器内,以形成气密密封。这具有将内含物密封在受控制的环境中的优点。
冷冻干燥器架通常由两个相对的不锈钢板形成,这两个相对的不锈钢板具有位于板之间的不锈钢肋条,以形成板之间的高度通常在10和20mm之间的空间以及用于透热流体的流动槽。肋条用于为架提供必要的强度,以支撑其自身的重量和置于其上的容器的重量。此外,肋条必须使架能够经受住在塞子下压的过程中置于板上的最高可为1.5千克/平方厘米的力。
容器的塞子通常由例如丁基橡胶的橡胶材料形成,并可包含应用到塞子的一定量的硅油,以帮助塞子塞入到容器内。在塞子压入到容器内的过程中,置于塞子上的压力可将小的硅油微粒驱赶到塞子的外部表面,从而在塞子和冷冻干燥器表面之间的界面处产生准粘性层(quasi-viscouslayer)。而且,数种塞子的设计,特别是用于包含药物样品的容器的那些设计具有位于中央的凸起的目标环(target ring)或“靶心”,从而界定了用于针的插入的目标区域。当该塞子由冷冻干燥器架的下部表面压入到容器内时,作用在目标环上的力使目标区域朝下弯曲,从而在塞子和冷冻干燥器架之间产生真空腔。
这些效果,不论单独还是结合,均可能在容器封闭过程中使塞子“粘黏”到冷冻干燥器架的下部表面,特别是当压力作用到塞子相对长的时间时,或当封闭压力相对高时。因此,当压力通过冷冻干燥器架之间的相对移动而随后从塞子释放时,在封闭过程中粘黏到上部架的塞子可仍然附着于上部架,从而使塞子位于其中的容器与下部架物理地分离。随着这些塞子和上部架的下部表面之间的粘合随着时间弱化,这些容器可从上部架落下,从而使容器因与下部架冲击和/或与位于下部架上的其它容器中的一些碰撞而破碎。可选地,这些容器可在卸载过程中从上部架移开,这也可使容器破碎和/或与其它容器中的一些碰撞。任何落下的容器或破碎的玻璃都有可能会阻碍卸载系统,因此需要操作员清理系统,从而造成昂贵的停工期和材料的损失。
在本发明的第一方面中,提供了制造具有相对的平行的第一和第二板的冷冻干燥器架的方法,该方法包括步骤:处理板中的一个的表面,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压该表面的橡胶塞子与该表面粘黏。
架的一个表面被处理成使得当架位于冷冻干燥器中时,架的该表面面向位于另一架上的容器的塞子,在架被用于将塞子挤压到容器中时,可阻止塞子与架粘黏。相对于单独处理容器的塞子的上部表面来说,这是有利的,因为该优点可使冷冻干燥器能广泛用于不同种类的塞子。
在一种实施方式中,表面通过在其上形成涂覆层来处理,在压力作用到橡胶塞子而将塞子推入容器内的过程中,涂覆层阻止挤压表面的橡胶塞子与架粘黏。该涂覆层优选包括疏水性(hydrophobic)的或不润湿(non-wetting)的材料,以在架被塞子挤压时,阻止塞子通过形成在涂覆层和塞子之间的任何准粘性层而与架粘黏。适当的不润湿的材料的实例为Teflon。
涂覆层可喷涂在表面上。这使得可通过将架从架所位于的冷冻干燥器的室中拆除并将涂覆层应用到架的表面而使涂覆层可适用于现有的冷冻干燥器架。可选地,涂覆层可在原位应用到架。
涂覆层可为至少两种材料的复合涂覆层。例如,陶瓷材料的第一层可应用到表面,不润湿材料的第二层应用到第一层,而第一和第二层随后被烘焙到,例如150至350℃的范围中的温度,优选200至250℃的范围中的温度,以形成涂覆层。第一层可使用热喷涂和等离子喷涂工艺中的一种来喷涂到表面上。陶瓷材料可包括碳、碳化钨和碳化硅中的一种。在该喷涂工艺中,表面的温度可局部地达到高达700℃的温度。为了避免由于材料应力消除而使架变形,可在喷涂工艺中在板之间传送透热流体,以确保恰当的冷却。
可选地或额外地,涂覆层可具有大于应用了该涂覆层的表面的粗糙度。增加架的表面的粗糙度能减少当塞子压入容器内时架和塞子之间的接触面积,并从而降低塞子和容器之间的粘合。而且,根据粗糙度的程度,可阻止在架和塞子之间形成任何真空腔。在第二实施方式中,不是通过将涂覆层应用到表面来增加表面的粗糙度,而是将表面自身弄粗糙,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压该表面的橡胶塞子与架粘黏。表面可使用激光束、电子束和化学蚀刻中的一种来处理,以从表面移除材料来提高其粗糙度。可选地,材料可沉积或以其它方法附着到表面来提高其粗糙度。该表面处理可在表面上形成规则的表面图案,以提供对表面中的“峰”的尺寸和/或间隔的更大的控制,“峰”在封闭过程中与塞子进行接触。表面图案可包括交叉线(cross hatching)、平行线和点阵中的一种。例如,将材料增加到表面可通过将丝网(wire mesh)连接到架的表面来进行,以提供用于接触塞子的峰的规则的图案。可通过仅来自例如两个或三个峰的相对小的峰来应用压力而将塞子塞入到容器内,且在一个实例中峰具有2至3mm的范围的段。
架的制造优选包括步骤:在板之间定位间隔件,以界定用于传送板之间的透热流体的至少一个流动槽,并将间隔件连接到板,其中表面处理是在将间隔件连接到板之后进行的。间隔件优选使用粘合剂或使用真空铜焊技术来连接到板。
在本发明的第二方面中,提供了包括相对的平行的第一和第二板的冷冻干燥器架,第一和第二板具有位于其间的至少一个流动槽,用于传送板之间的透热流体,板中的一个具有经处理的表面,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压该表面的橡胶塞子与架粘黏。
如以上所讨论的,在一种实施方式中,表面具有其上的涂覆层,在压力作用到橡胶塞子而将塞子推入容器内的过程中,涂覆层阻止挤压该表面的橡胶塞子与架粘黏。在另一实施方式中,表面被弄得粗糙,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压该表面的橡胶塞子与架粘黏。
在第三方面中,本发明提供了包括覆盖多个架的室的冷冻干燥器,每一架包括相对的平行的第一和第二板,第一和第二板具有位于其间的至少一个流动槽,用于传送板之间的透热流体,每一架具有经处理的表面,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压该表面的橡胶塞子与架粘黏。
以上关于本发明的方法方面描述的特征也可等同地应用于装置(架或干燥器)方面的任何特征,且反之亦然。
现将参考附图描述本发明的优选特征,其中
图1是断开了一块板的冷冻干燥器架的顶部平面图;
图2是图1的架的部分的透视图;
图3是本发明的第一实施方式中的图2的部分的特写;
图4是图2的本分的特写,以展示本发明的第二实施方式;
图5是图4的架的板12的外露的表面的平面图;
图6是图2的部分的特写,以展示本发明的第三实施方式。
参考图1和2,冷冻干燥器架10包括一对第一和第二板12、14。两块板均为平的彼此平行和间隔开的。多个肋条16设置在形成在第一和第二板12、14之间的空间内。肋条16被间隔开,以界定至少一个流动槽18,用于在第一和第二板12、14之间传送透热流体。在该方面,肋条16相对于彼此基本上平行和错开,以产生穿过架10的蜿蜒的流动路径,并因此使压力下降最小化。尽管肋条16可采用具有分别与第一和第二板12、14接触的细长的平的表面20、22的任何形式,但是其优选为中空矩形管。
架10由包含棒或杆26、28、30、32的框架24来外围地密封,每一棒或杆具有基本上方形的或矩形的横截面。杆都被端部到端部的连接,并固定到第一和第二板12、14。透热流体通过流体入口孔和出口孔来流入和排出架10,流体入口孔和出口孔通过连接到设置有内部钻孔的入口和出口接头部分38、40的入口管和出口管34、36来形成。入口和出口管34、36连接到软管,软管又连接到用于透热流体的外部回路,该外部回路通常包括循环透热流体的泵、用于在冷冻干燥过程的冷冻阶段中冷却透热流体的制冷回路(refrigerant circuit)以及用于在冷冻干燥过程的升华阶段中加热透热流体的电加热器。支撑块可设置在架10的外部边界上,用于接纳用于将架10连接到冷冻干燥器的室内的其它架的支撑杆。
冷冻干燥器架10的所有前述部件都优选由不锈钢制成。要制造架10,可使用粘合剂或通过铜焊将板12、14连接到肋条16。为了使用铜焊工艺来组装架10,将自粘合衬背(self-adhesive backing)或铜焊带(brazing tape)上的镍基或铜基粉末夹在第一板12和肋条16的下部表面22之间以及第二板14和肋条16的上部表面20之间。将该组装件夹在石墨块或任何导热材料之间,并置于真空感应炉内。以从室温升高到大约482℃的距镍的熔化大约10℃的温度来在炉内加热该组装件。随后稳定温度,并随后又升高到镍的熔点和不锈钢的结晶温度。稳定该温度15到20分钟,以消除部件的组装件的应力。此后,将炉子冷却12小时至204℃,在该温度下,用例如氮的惰性气体对整个组装件进行淬火。此后,使该组装件冷却到室温。随后将端部板30、32焊接到板12、14,并优选进行磨削、研磨和抛光。
在组装了架10的这些部件之后,对第一板12的外露的(如所展示的下部的)表面50进行处理,以在压力作用到塞子而将塞子推入容器内的过程中,阻止挤压表面50的橡胶塞子与表面50粘黏。如以下参考图3至6所描述的,架10的表面50可以数种不同的方式来处理,以在容器封闭过程中避免橡胶塞子与架10粘黏。
在展示在图3中的第一实施方式中,通过在表面50上形成涂覆层60来处理表面50,在容器封闭过程中,涂覆层60能避免橡胶塞子与架10粘黏。在该实施方式中,涂覆层为两种不同材料的复合涂覆层。使用热喷涂和等离子喷涂工艺,将例如碳、碳化钨和碳化硅的陶瓷材料的第一层应用到表面50。在该喷涂工艺中,表面50的温度可局部地达到高至700℃的温度,且因而优选在喷涂过程中穿过架10传送透热流体,以从表面50带走热,并因此避免架的变形。在将陶瓷材料喷涂到表面50上之后,将例如Teflon的疏水性的或不润湿的材料的第二层应用到第一层,并随后以从150至350℃的范围内的温度烘焙第一层和第二层,且优选从200至250℃的范围内,以形成涂覆层60。
涂覆层60可执行两种功能。首先,当架10挤压塞子时,该涂覆层可提供疏水性界面,这样的疏水性界面能防止塞子通过形成在涂覆层60和塞子之间的准粘性层而粘黏到架10。其次,涂敷层60可具有大于应用了该涂敷层的不锈钢表面50的粗糙度。增加架10的在容器封闭过程中与塞子进行接触的表面的粗糙度可减少当塞子压入容器内时架10和塞子之间的接触面积,并因此降低塞子和容器之间的粘合。而且,根据粗糙度的等级,可阻止在架10和塞子之间形成任何真空腔。
图4和5展示了第二实施方式,其中表面50使用激光束、电子束和化学蚀刻中的一种来处理,以将材料从表面50去除,如由图4中的凹陷70所展示的,以增加其粗糙度,并因此在容器封闭过程中阻止挤压表面50的橡胶塞子粘黏到架10。该表面处理可在表面50上形成规则的表面图案70,以为表面50中的“峰”的尺寸和间隔提供控制,“峰”与塞子在封闭过程中接触。表面图案可包扩交叉线(如展示在图5中的)、平行线和点阵中的一种。在展示在图5中的实例中,峰具有2至3mm的范围中的段。
图6展示了第三实施方式,其中表面50通过将丝网80作用到表面50而变得粗糙,同时增加了表面50的粗糙度,并为表面50中的在封闭过程中与塞子接触的峰的尺寸和/或间隔提供了控制。
Claims (21)
1.一种制造具有相对的平行的第一板和第二板的冷冻干燥器架的方法,所述方法包括步骤:处理所述板中的一个的表面,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压所述表面的橡胶塞子与所述表面粘黏,所述处理包括将所述表面弄粗糙的步骤。
2.如权利要求1所述的方法,其中所述表面是使用激光束、电子束和化学蚀刻中的一种来处理的。
3.如权利要求1所述的方法,其中通过所述处理而在所述表面上形成规则的表面图案。
4.如权利要求1所述的方法,其包括步骤:将间隔件定位在所述板之间,以界定至少一个流动槽,用于在所述板之间传送透热流体,并将所述间隔件连接到所述板,其中对所述板中的一个的所述表面的处理是在将所述间隔件连接到所述板之后进行的。
5.如权利要求4所述的方法,其中所述间隔件是使用粘合剂或使用真空铜焊技术连接到所述板的。
6.如权利要求1所述的方法,其中所述弄粗糙的步骤是通过在所述表面上形成涂覆层实现,所述涂覆层具有大于所述板中的一个的所述表面的粗糙度。
7.如权利要求6所述的方法,其中所述涂覆层是喷涂到所述表面上的。
8.如权利要求6或7所述的方法,其中至少陶瓷材料的第一层应用到所述表面,至少不润湿材料的第二层应用到所述第一层,而所述第一层和第二层随后被烘焙来形成所述涂覆层。
9.如权利要求8所述的方法,其中所述第一层是使用热喷涂和等离子喷涂技术中的一种来喷涂在所述表面上的。
10.如权利要求9所述的方法,其中在将所述第一层喷涂在所述表面上的过程中,透热流体在所述板之间传送。
11.如权利要求8所述的方法,其中所述陶瓷材料包括碳、碳化钨和碳化硅中的一种。
13.如权利要求8所述的方法,其中所述层被加热到150至350℃的范围内的温度。
14.如权利要求13所述的方法,其中所述层被加热到200至250℃的范围内的温度。
15.一种冷冻干燥器架,其包括相对的平行的第一板和第二板,所述第一板和所述第二板具有位于其间的至少一个流动槽,用于传送所述板之间的透热流体,所述板中的一个具有经过弄粗糙的处理的表面,以在压力作用到橡胶塞子而将塞子推入容器内的过程中,阻止挤压所述表面的橡胶塞子粘黏到所述架。
16.如权利要求15所述的架,其中所述弄粗糙的表面具有大于所述板中的一个的所述表面的粗糙度。
17.如权利要求15所述的架,其中所述表面具有形成在其上的规则的表面图案。
18.如权利要求17所述的架,其中所述表面图案包括交叉线、平行线和点阵中的一种。
19.如权利要求15所述的架,其包括位于所述板之间的多个间隔件,以界定所述至少一个流动槽,用于传送所述板之间的透热流体。
20.如权利要求19所述的架,其中所述间隔件是使用粘合剂连接到所述板的或被铜焊到所述板。
21.一种冷却干燥器,其包括覆盖多个架的室,所述架中的每一个都依据权利要求15,所述架中的每一个的所述表面都面朝下。
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-
2006
- 2006-05-09 GB GB0609113A patent/GB0609113D0/en not_active Ceased
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2007
- 2007-05-08 ES ES07724290.7T patent/ES2689909T3/es active Active
- 2007-05-08 EP EP07724290.7A patent/EP2021714B1/en active Active
- 2007-05-08 JP JP2009508158A patent/JP5751752B2/ja active Active
- 2007-05-08 WO PCT/EP2007/003352 patent/WO2007128385A1/en active Application Filing
- 2007-05-08 CN CN2007800164033A patent/CN101449125B/zh active Active
- 2007-05-08 DK DK07724290.7T patent/DK2021714T3/en active
-
2008
- 2008-11-07 US US12/267,466 patent/US8722169B2/en active Active
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Also Published As
Publication number | Publication date |
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US20090178293A1 (en) | 2009-07-16 |
JP6009019B2 (ja) | 2016-10-19 |
DK2021714T3 (en) | 2018-10-22 |
GB0609113D0 (en) | 2006-06-21 |
JP2009536310A (ja) | 2009-10-08 |
ES2689909T3 (es) | 2018-11-16 |
WO2007128385A1 (en) | 2007-11-15 |
EP2021714A1 (en) | 2009-02-11 |
CN101449125A (zh) | 2009-06-03 |
JP2015108507A (ja) | 2015-06-11 |
US8722169B2 (en) | 2014-05-13 |
EP2021714B1 (en) | 2018-07-11 |
JP5751752B2 (ja) | 2015-07-22 |
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