CN100427043C - 可剥离的外袋薄膜 - Google Patents

可剥离的外袋薄膜 Download PDF

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CN100427043C
CN100427043C CNB2004800026843A CN200480002684A CN100427043C CN 100427043 C CN100427043 C CN 100427043C CN B2004800026843 A CNB2004800026843 A CN B2004800026843A CN 200480002684 A CN200480002684 A CN 200480002684A CN 100427043 C CN100427043 C CN 100427043C
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outer bag
layer structure
polymer layer
structure thing
copolymer
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CN1741771A (zh
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让-皮埃尔·哈特曼
帕特里克·巴尔托
保罗-安德烈·戈利耶
佛朗哥·佩卢索
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Baxter Healthcare SA
Baxter International Inc
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Baxter Healthcare SA
Baxter International Inc
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Abstract

本发明提供了可剥离的聚合物层结构(16)，其具有：包括含乙烯聚合物的第一密封剂层(30)，和包括含聚丙烯聚合物的第二密封剂层(34)，该第二密封剂层沿可剥离的封口连接到第一密封剂层。本发明还提供了一种外袋容器(10)，其包括：具有含乙烯聚合物的第一密封剂层(30)的第一侧壁(12)，和具有含丙烯聚合物的第二密封剂层(34)的第二侧壁(14)。第二密封剂层沿可剥离的周边封口(16)连接到第一密封剂层。

Description

可剥离的外袋薄膜
技术领域
本发明一般地涉及聚合物层结构，其特征为可剥离的封口，更具体地，本发明涉及这种材料在制作可剥离的外袋等方面的用途
发明背景
在医学领域，一次性容器用于收集、储存、运输和最终递送治疗性流体、营养性溶液、呼吸治疗剂、透析液、血液、血液制品、血浆衍生物、血浆增容剂、血液替代品、抗凝血剂、血液防腐剂和其他治疗剂。经常地，这些一次性容器被放入二级容器如外袋中，以保持在一次性容器内包含的药剂的完整性和体积。一次性容器可被连接到一个或多个管状装置上，并可与其他容器一起形成治疗性流体递送装置。外袋必须具有独特的性质组合。比如，希望外袋在视觉上是透明的，以便目视检查一次性容器的内容物，检查其中是否包含药剂的污染物。至少其透明度必须使得容器的标签纸(label copy)是可识的。材料还必须在一个宽的温度范围内有效，包括经受压热或灭菌过程的能力，所述过程经常使用约121℃温度和高压下的蒸气完成。
外袋还必须与构成一次性容器的薄膜及其自身相容。也就是说，外袋不能变皱、脱色、或粘在其他外袋或一次性容器上，这些因素的每种都会削弱(如果不排除)不除去外袋而目视检查一次性容器的能力。
外袋还必须允许容易进入一次性容器内部，这通过提供“易打开的”部件如开口条、凹口、狭缝或类似物实现，其中不需要切割工具。
还希望外袋不含或者含少量的低分子量添加剂如增塑剂、稳定剂等，这些添加剂会被释放进入在外袋内一次性容器中所包含的药物或者生物流体中，从而潜在地对使用这种装置的病人造成危险。迄今，用来制作外袋的工业标准材料一直为高密度聚乙烯(HDPE)如Fina7194，它由AtoFina Oil and Chemical Co.在市场上出售。
提供了本发明以解决这些和其他问题。
发明概述
本发明提供了一种可剥离的聚合物层结构，其具有：第一密封剂层，包括含乙烯的聚合物；第二密封剂层，包括含聚丙烯的聚合物，该第二密封剂层沿着可剥离的封口连接到第一密封剂层上。
本发明还提供了一种外袋容器，其包括：第一侧壁，具有含乙烯的聚合物的第一密封剂层；第二侧壁，具有含丙烯的聚合物的第二密封剂层。第二密封剂层沿着可剥离的周边封口连接到第一密封剂层上。本发明的这些和其他方面和特征将会参照下面的附图和相应的说明书进行讨论。
附图简述
图1是本发明的可剥离的密封外袋的透视图。
图2a是本发明的可剥离的密封外袋的透视图，该外袋部分地包括腹膜透析装置。
图2b是腹膜透析递送系统的透视图。
图3是本发明的聚合物层结构的示意图。
图4是本发明的另一种聚合物层结构的示意图。
图5是本发明实施方案的多层结构的横截面图。
图6是本发明实施方案的多层结构的横截面图。
优选实施方案详述
尽管本发明允许很多不同形式的实施方案，但如图所示，本文将详细描述几个具体实施方案，应理解本公开内容被视为本发明原理的范例，而不打算将本发明限于所说明的具体实施方案。
根据本发明，提供了聚合物层结构和由其制得的可剥离外袋，满足以上要求。通过将外袋侧壁的周边部分密封在一起而形成剥离封口，由此可剥离的外袋给内容物提供了便利通道。剥离封口应该足够牢固，以在典型的运输和储存过程中保持完整性和气密性，直到包装被最终用户打开。剥离封口不应该太耐久，以免当最终用户以平常的手压力将薄膜拉开时，无法轻易打开(即剥开)剥离封口。
还有一点很重要的是，从密封包装被初始构造直到打算打开该包装，这种密封强度和剥离容易性的平衡应保持相对稳定。当包装在打开之前打算经历极端的温度波动时，这一点是特别关注的。例如，包含食品的密封包装通常被设计成在冷冻条件下储存，最后被放入加热源如微波炉或者沸水容器中。
众所周知，各种医疗用品在使用之前要求灭菌。一种常用的热灭菌技术涉及使用压热器法来杀死微生物。具有可耐用的且可剥离的封口的聚合物膜包装系统可以用于封装在使用之前要求灭菌的医疗用品。在这点上，可剥离的封口必须经受与灭菌相关的高温，并在其后保持其可剥离性。
图1展示了可剥离外袋10，其具有相对的第一和第二侧壁12和14，它们沿着周边部分密封在一起，形成剥离封口16。侧壁可以是多层结构或者单层结构。一个侧壁可以是多层结构，而相对侧壁是单层结构。封口宽度可以是足够窄，形成室18，其中可在外袋完全封闭之前放入内容物。在封口周边外的一个或多个位置处，未密封的腹板(web)的一部分保持为突出状的夹持区域19，可以用手指或其他方式抓住它，以开始必要的牵引过程来打开封口。
图2a展示了本发明的可剥离外袋10，其部分地包含持续不卧床腹膜透析装置20。图2b展示了没有包装的装置20。预计了可装入不同治疗性溶液的容器，所述治疗性溶液为例如I.V.溶液、药物溶液、血液、血液制品、肾溶液、血浆衍生物、血浆增容剂、血液替代品、抗凝血剂、血液防腐剂和其他治疗剂。还可预计，储存其他医疗装置如外科器械、给药装置、溶液容器等。然而，必须理解，使用可剥离的外袋进行包装的制品不限于医疗装置，因此这种制品的性质和类型将根据需要的应用而有很大的变化。
图3展示了本发明的优选形式，第一侧壁12和第二侧壁14都是多层结构；图4展示了第一侧壁12和第二侧壁14都是单层结构。图3展示的第一侧壁12具有第一密封剂层30和第一外层32。第二侧壁14具有第二密封剂层34和第二外层36。所有或部分的第一和第二侧壁可以密封在一起，封口在各个侧壁的内部密封剂表面之间形成。可预计，一个侧壁可以是多层结构，而相对侧壁可以是单层或多层结构，具有与另一个侧壁相同或不同的层数。
通过在指定的夹持区域19开始启封过程，可以拉开剥离封口16。随着两个侧壁逐渐被剥开，其中的内容物相应地被逐渐暴露。继续剥离可最终导致两个侧壁12和14的完全分离。封口16被设计成可在任何与封口长度基本平行的方向上拉开。所以，图1中位置X处的封口分离通过在与封口16宽度成直角的方向38上牵引侧壁而容易进行，而在与封口16宽度平行的方向40上牵引侧壁时，封口将相对地难于分离。
侧壁之间的密封理想地是在高于内部密封剂层30和34的熔点的温度下密封而形成的。外层32或36中的至少一个应具有高于密封温度的熔点温度，以避免损害与密封模接触的外表面的完整性。
在侧壁的密封部分之间的粘合强度或剥离强度受至少两种不同的现象控制。首先，不限于具体理论，据信，因为两个密封剂层由于模而熔化，从而在这两个密封剂层之间产生粘性流，由此产生机械联锁，这是第一种现象。如上所述，当在与封口方向垂直的方向上剥离时，这产生了高剥离强度。另外，在与封口平行的方向上更容易剥离封口，这种性质被认为主要受施加于密封模的压力控制。
对本发明的封口性质有贡献的第二种现象涉及密封剂层所选材料的组成。已知，组合不相容的材料会形成非耐久性封口。更详细地说，具有高相容性的材料倾向于形成较强的封口，而低相容性的材料则形成较弱的封口。
用于第一密封剂层30的合适材料选自聚烯烃，其衍生自具有2至20个碳原子的α-烯烃单体。因此，合适的聚烯烃包括乙烯、丙烯、丁烯、戊烯、己烯、庚烯、辛烯等的均聚物、共聚物和三元共聚物、及它们组成的掺合物。
在本发明的一个优选形式中，聚烯烃是乙烯的均聚物或共聚物。乙烯均聚物包括高密度聚乙烯(HDPE)、中密度聚乙烯(MDPE)和低密度聚乙烯(LDPE)，最优选的是HDPE。合适的HDPE包括密度为大于0.915克/立方厘米至约0.970克/立方厘米的那些HDPE，甚至更优选密度为约0.955克/立方厘米至约0.965克/立方厘米的HDPE。
合适的乙烯共聚物是通过将乙烯单体与具有3至20个碳原子、更优选3至10个碳原子、最优选4至8个碳原子的α-烯烃聚合而得到的。还希望乙烯共聚物的密度按照ASTM D-792测量为小于约0.915克/立方厘米、更优选小于约0.910克/立方厘米、甚至更优选小于约0.900克/立方厘米。这种聚合物经常被称为VLDPE(极低密度聚乙烯)或ULDPE(超低密度聚乙烯)。优选地，使用单点催化剂、甚至更优选金属茂催化剂体系来制备乙烯α-烯烃共聚物。据信，单点催化剂具有单个的、空间上和电子上等效的催化剂位置，这与齐格勒-纳塔(Ziegler-Natta)类型催化剂相反，已知后者具有多个催化剂位点的混合体。这种单点催化的乙烯α-烯烃由Dow以商品名AFFINITY出售，DuPont Dow以商标
Figure C20048000268400141
出售，以及Exxon以商品名EXACT出售。这些共聚物有时在本文中称为m-ULDPE。
合适的乙烯共聚物还包括乙烯和低级烷基丙烯酸酯的共聚物、乙烯和低级烷基取代的烷基丙烯酸酯共聚物、和乙烯-乙酸乙烯酯的共聚物，其乙酸乙烯酯的含量按共聚物的重量计为约8％至约40％。术语“低级烷基丙烯酸酯”是指具有图1所示分子式的共聚单体：
Figure C20048000268400142
图1
R基团是指具有1-17个碳原子的烷基。因此，术语“低级烷基丙烯酸酯”包括但不限于：丙烯酸甲酯、丙烯酸乙酯、丙烯酸丁酯等。
术语“烷基取代的烷基丙烯酸酯”是指具有图2所示分子式的共聚单体：
Figure C20048000268400143
图2
R1和R2为具有1-17个碳原子的烷基，可具有相同或不同的碳原子数。因此，术语“烷基取代的烷基丙烯酸酯”包括但不限于：甲基丙烯酸甲酯、甲基丙烯酸乙酯、乙基丙烯酸甲酯、乙基丙烯酸乙酯、甲基丙烯酸丁酯、乙基丙烯酸丁酯等。
合适的含丙烯的聚合物包括聚丙烯的均聚物和共聚物。合适的聚丙烯均聚物可具有非晶形的、全同立构的、间同立构的、无规立构的、半全同立构的、或立构嵌段的立体化学结构。在本发明的一个优选形式中，使用单点催化剂得到聚丙烯的均聚物。
通过使丙烯单体与具有2-20个碳原子的α-烯烃聚合，得到合适的丙烯共聚物。在本发明的一个更优选形式中，使丙烯与一定量的乙烯共聚合，所述量按共聚物的重量计为约1％-约20％、更优选约1％-约10％、最优选2％-约5％。含大于5wt％乙烯的丙烯-乙烯共聚物在本文中称为具有高乙烯含量的丙烯-乙烯共聚物。丙烯-乙烯共聚物可以是无规共聚物或嵌段共聚物。丙烯无规共聚物可以是多相的。“多相的”是指丙烯共聚物的制备是在两级法中进行的，产生具有均聚物基体和由非晶形EP共聚物(“橡胶”)和结晶PE组成的夹杂物的多相结构。相对于基体，弹性体相的摩尔量和组成的变化允许性质(刚性、韧性和透明性)有很大变化。
在本发明的优选形式中，使用单点催化剂得到丙烯共聚物。
还可以使用聚丙烯和α-烯烃共聚物的掺合物，其中丙烯共聚物可以根据α-烯烃中的碳数而变化。例如，本发明预计了丙烯和α-烯烃共聚物的掺合物，其中一种共聚物具有2个碳原子的α-烯烃，另一种共聚物具有4个碳原子的α-烯烃。还可以使用具有2-20个碳原子、更优选2-8个碳原子的α-烯烃的任意组合。因此，本发明预计了丙烯和α-烯烃共聚物的掺合物，其中第一和第二α-烯烃具有下列碳数组合：2和6、2和8、4和6、4和8。还预计在掺合物中使用大于2种聚丙烯和α-烯烃共聚物。使用催化合金(catalloy)方法得到合适的聚合物。
还希望使用高熔体强度的聚丙烯。高熔体强度的聚丙烯可以是聚丙烯的均聚物或共聚物。高熔体强度的聚丙烯已知具有自由端长链的丙烯单元分支。制备具有高熔体强度特征的聚丙烯的方法已描述于美国专利US 4,916,198、5,047,485和5,605,936中，它们被包含在本文中作为参考并成为本文的一部分。一种这样的方法包括在如下环境中辐照线性丙烯聚合物，其中活性氧浓度按体积计为约15％，高能量电离能的辐射剂量为1-104兆拉德/分钟，辐照时间足以引起线性丙烯聚合物大量断链，但不足以使材料变得胶粘。辐照导致断链。链片段的后续重组导致新链的形成，并将链片段连接为链以形成分支。这进一步导致所需的自由端长链支化的、高分子量、非线性丙烯聚合物物质。保持辐照，直至形成大量长链分支。然后处理该物质，以使存在于被辐照物质中的基本上所有的自由基去活化。
还可以按美国专利5,416,169中所述(该文献以全文引入本文以供参考，并成为本文的一部分)，当指定的有机过氧化物(过氧化二碳酸二-2-乙基己酯)与聚丙烯在指定条件下反应，然后熔融捏合，就可以得到高熔体强度聚丙烯。这种聚丙烯是线性的结晶聚丙烯，具有基本上为1的支化系数，因此没有自由端长链支化，将具有约2.5dl/g-10dl/g的特性粘度。
用于第二密封剂层34的合适材料选自与第一密封剂层30相同的聚合物材料组，但与其不同，在本发明的优选形式中，所述合适材料是在密封上不相容的。当材料彼此是不混溶的或不可混合的，那么材料就是不相容的。例如，如果第一密封层30是聚乙烯，第二密封剂层34可以是聚丙烯、聚丁烯、苯乙烯-乙烯-丁二烯-苯乙烯(SEBS)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-异丙烯-苯乙烯(SIS)、或任何其他疏水聚合物。
如上所述，本发明人在这里发现，不相容聚烯烃的不同组合为本发明的密封剂层提供了合适的原材料。以与高密度聚乙烯具有最高到最低的相容性的顺序列出了下面的材料：高密度聚乙烯、线性低密度聚乙烯、低密度聚乙烯、具有高乙烯含量的聚丙烯无规多相共聚物、具有高乙烯含量的聚丙烯无规共聚物、和聚丙烯均聚物。换句话说，对于这些聚烯烃，最高特性粘合强度将通过高密度聚乙烯和高密度聚乙烯之间的封口表现出来。相反地，最低粘合将通过高密度聚乙烯和聚丙烯均聚物而得到。
本发明还预计了，使用具有两种或多种组分的聚合掺合物用于第一和第二密封剂层30和34。在本发明的优选形式中，用于第一密封剂层30的聚合掺合物为双组分掺合物，含有约95％-约5％的第一聚烯烃以及所掺合的量为约5％-约95％的第二聚烯烃。第二密封剂层34可以是上述两种或多种不同聚丙烯聚合物的掺合物，如约99％-约1％的一种聚丙烯和约1％-约99％的第二聚丙烯的双组分掺合物。
通过接合第一密封剂层30和第二密封剂层34形成的剥离封口的合适层结构包括但不限于：(1)HDPE/聚丙烯无规共聚物(乙烯含量1-3％)，和(2)HDPE/90％PP无规共聚物，含有10％PP无规多相共聚物。掺合物中组分的相对量以重量百分比表示，除非另有说明。
附加的合适层包括：LLDPE或MDPE的第一密封剂层30、和含聚丙烯的聚合物的第二密封剂层34。HDPE可以是Stamylex 90-89，由DEXPlastomers o.f.v.of Heerlen，The Netherlands制造。MDPE可以是Stamylex 40-46-48，由DEX制造。LLDPE可以是Stamylex 1026，也由DEX制造。含聚丙烯聚合物可以是Borealis RD204CF，由BorealisGMBH of Burghausen，Germany制造，或者是Adflex C200F，由BasellPolyolefins Company N.V.of Hoofddorp，The Netherlands制造。
具有不相容接合层的其他层结构包括：例如聚丁烯层连接到聚丙烯层，以及聚丁烯层连接到聚乙烯层。
用于第一外层32和/或第二外层36的合适材料包括聚烯烃、聚酰胺、聚酯、与下列一种或多种单体共聚合的乙烯的均聚物和共聚物，所述单体为：例如具有2-20个碳原子的羧酸及它们的酯衍生物、丙烯酸、丙烯酸的酯衍生物、烷基取代的丙烯酸、丙烯酸的烷基取代酯、乙酸乙烯酯、丙烯酸乙烯酯等。在本发明的优选形式中，第一外层32为聚酰胺，更优选尼龙6。合适的尼龙6售自EMS-Chemie A.G.ofDomat/Ems，Switzerland，商品名为Grillon XE 3615。外层32和36也可以包括这种材料的掺合物。在另一个优选实施方案中，第一外层32为聚酰胺，更优选尼龙6，第二外层36为LLDPE。
尤其优选聚酰胺作为在本发明的任意外层内的组分。优选地，聚酰胺选自：在具有4-12个碳原子的内酰胺的开环反应中产生的聚酰胺、由碳数在2-13范围内的二胺的缩合反应产生的酯族聚酰胺、由碳数在2-13范围内的二酸的缩合反应产生的酯族聚酰胺、由二聚脂肪酸的缩合反应产生的聚酰胺、和含酰胺的共聚物(无规、嵌段或接枝)。
合适的聚酯包括二羧酸或聚羧酸和二元醇或多元醇或烯化氧的缩聚产物。在本发明的优选形式中，聚酯为聚酯醚。合适的聚酯醚通过使1，4-环己烷二甲醇、1，4-环己烷二羧酸和聚丁二醇醚反应得到，通常被称为PCCE。合适的PCCE售自Eastman，商品名为ECDEL。合适的聚酯还包括聚酯弹性体，它们是聚对苯二甲酸丁二酯的硬结晶片段和软(非晶态)聚醚二醇的第二片段的嵌段共聚物。这种聚酯弹性体售自Du Pont Chemical Company，商品名为
Figure C20048000268400181
图5显示了剥离封口结构的优选例子，其具有多层结构的第一侧壁12，该第一侧壁具有HDPE的第一密封剂层30、聚酰胺-尼龙6的第一外层32、和在它们之间的马来酐接枝的聚乙烯(MAH-PE)的第一连接件层40，所述马来酐接枝的聚乙烯(MAH-PE)为例如OREVAC18305，由ATO Fina制造。第二侧壁14具有PP无规共聚物的第二密封剂层34、聚酰胺-尼龙6的第二外层36、和在它们之间的马来酐接枝的聚丙烯(MAH-PP)的第二连接件层42，所述马来酐接枝的聚丙烯(MAH-PP)为例如Admer QF 300E，来自Mitsui Chemicals，Inc.of Tokyo，Japan。第一侧壁12和第二侧壁14有时也被称为腹板。
图6显示了本发明的另一个优选实施方案，其具有多层结构的第一侧壁12，该第一侧壁具有HDPE的第一密封剂层30、聚酰胺-尼龙6的第一外层32、和在它们之间的马来酐接枝的聚乙烯(MAH-PE)的第一连接件层40，所述马来酐接枝的聚乙烯(MAH-PE)为例如OREVAC18305，由ATO Fina制造。第二侧壁14具有PP无规共聚物的第二密封剂层34、聚酰胺-尼龙6的中间层44、和在它们之间的马来酐接枝的聚丙烯(MAH-PP)的第二连接件层42，所述马来酐接枝的聚丙烯(MAH-PP)为例如Admer QF 300E，来自Mitsui Chemicals，Inc.of Tokyo，Japan。另外，第二侧壁14包括第三连接件层46和第二外层36。第三连接件层46是MAH-PP，第二外层36是LLDPE。
连接件层可选自本领域已知的那些材料。例如，合适的连接件层包括改性的聚烯烃与未改性的聚烯烃的掺合物。改性的聚烯烃典型地为聚乙烯或聚乙烯共聚物。聚乙烯可以是ULDPE、低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)、中密度聚乙烯(MDPE)、和高密度聚乙烯(HDPE)。改性聚乙烯的密度为0.850-0.95克/立方厘米。更具体地，通过其他例子，除了上述的MAH-PE或MAH-PP之外，连接件层还可由改性的乙醚-丙烯共聚物组成，如那些以产品名PLEXAR(Quantum Chemical Co.)和BYNEL(Dupont)出售的那些。
本发明层的相对厚度如下：第一外层的厚度应为约5-70微米、更优选15-60微米、或其中任意的范围或范围组合。第一密封剂层的厚度应为约50-110微米、更优选约60-90微米、或其中任意的范围或范围组合。第二密封剂层的厚度应为约30-80微米、更优选约35-75微米、或其中任意的范围或范围组合。第二外层的厚度应为约5-110微米、更优选15-100微米、或其中任意的范围或范围组合。连接件层的厚度应为约2-12微米、更优选4-10微米、或其中任意的范围或范围组合。
因为本发明层的总数可根据层结构的目的用途而改变，所以层结构的总厚度也因此而改变。
当以与封口方向垂直的方向对本发明封口施加拉力时，封口的强度优选为约2N/15mm-约25N/15mm。另外，当以与封口方向平行的方向对封口施加拉力时，封口强度优选为约0.5N-约7.6N。当比较在压热过程之前的外袋和在121℃下进行压热过程1小时后的外袋时，封口强度的变化不超过约50％。
侧壁可以按本领域技术人员熟知的标准技术来处理，这些技术包括挤出、共挤出、浇注共挤出、挤出涂覆、层压或其他可接受的方法。
优选地，使用浇注共挤出方法来制作侧壁。该方法应基本上不含滑爽剂和其他可能将可提取物增加至不可接受水平的低分子量添加剂。
对具有如下组分和重量百分比的膜例子进行了测试。
实施例1：第一块板具有70微米厚的HDPE的第一密封剂层、7微米厚的MAH-PE的连接件层、和18微米厚的尼龙6的第一外层。它还包括第二块板，其具有45微米厚的聚丙烯的第二密封剂层、9微米厚的MAH-PP的第二连接件层、和28微米厚的尼龙6的中间层。另外，第二块板包括9微米厚的MAH-PP的第三连接件层、和90微米厚的LLDPE的第二外层。通过HDPE层接触聚丙烯层使第一块板和第二块板热密封在一起。实施例1对应于图6。
实施例2：第一块板具有70微米厚的HDPE的第一密封剂层、7微米厚的MAH-PE的连接件层、和18微米厚的尼龙6的第一外层。它还包括第二块板，其具有92微米厚的90％PP无规共聚物+10％PP无规多相共聚物的第二密封剂层、9微米厚的MAH-PP的连接件层、和56微米厚的尼龙6的第二外层。实施例2对应于图5。
对实施例1和2进行了下列试验。对于这两个实施例，通过HDPE层接触聚丙烯掺合物层使第一块板热密封到第二块板。
(1)可压热性：
通过如下显示可压热性：制作几个一次性袋，用蒸馏水填充它们，用上面实施例2中形成的膜组合物作为它们的外袋，在压热器中对它们在121℃下进行蒸汽灭菌60分钟，反压力为28磅/平方英寸。然后通过切开可剥离外袋的一端，使一次性袋从可剥离外袋中移出，使外袋的剩余部分进行下述的密封强度测试。
(2)机械模数和回复率：
具有已知几何形状的压热膜样品被安装在饲服液压驱动的机械测试器上，该测试器具有滑块来拉伸样品。在10英寸(25cm)/分钟的滑块速度下，样品被拉伸至约20％的伸长率。此时，滑块移动，然后以与初始用于拉伸样品的方向相反的方向反向移动。在数字记录器上记录应力应变状态。通过应力-应变曲线上的初始斜率得到弹性模数(“E(kg/mm2)”)，从过量样品尺寸得到样品伸长的百分率，作为回复率。
对于实施例1和2，第一块板在纵向上的弹性模数为95kg/mm2。在横向挤出方向上的弹性模数为100kg/mm2。对于实施例1，第二块板在纵向和横向挤出方向上的弹性模数为55kg/mm2。对于实施例2，第二块板在纵向上的弹性模数为90kg/mm2，在横向挤出方向上的弹性模数为85kg/mm2。
(3)光学透明度
压热后的膜样品首先被切割为约2×2英寸(5×5cm)的正方形，安装在Hunber Colorimeter上，根据ASTM D-1003测量它们的内部浊度。对于实施例1和2，第一块板的浊度％为26％±5％。对于实施例1，第二块板的浊度％为30％±3％。对于实施例2，第二块板的浊度％为12％±3％。
(4)封口强度
为了确定剥离封口强度，在垂直和平行于封口方向的两个方向上拉伸测试15mm宽的密封层条。对于实施例1和2，发现在平行于封口方向的方向上，在121℃下蒸汽灭菌后分离封口所需的力为0.50-7.6N/15mm。在垂直于封口方向的方向上，分离封口所需的力为17N/15mm。
应理解，考虑到上述本发明实施方案的描述，本领域的普通技术人员可以作出各种修改。这种修改被确定包括在下面的权利要求书中。

Claims (66)

1.一种可剥离的聚合物层结构物，包括
第一密封剂层，包括乙烯均聚物，和
第二密封剂层，包括含聚丙烯的聚合物，该第二密封剂层沿可剥离的封口连接到第一密封剂层。
2.如权利要求1所述的聚合物层结构物，其中乙烯均聚物选自如下任一种：高密度聚乙烯、中密度聚乙烯和线性低密度聚乙烯。
3.如权利要求2所述的聚合物层结构物，其中第一密封剂层为高密度聚乙烯。
4.如权利要求1所述的聚合物层结构物，其中第二密封剂层选自如下任一种：丙烯均聚物和丙烯共聚物。
5.如权利要求4所述的聚合物层结构物，其中第二密封剂层为丙烯均聚物。
6.如权利要求5所述的聚合物层结构物，其中丙烯均聚物具有选自如下任一立体化学结构：(a)非晶形的、(b)全同立构的、(c)间同立构的、(d)无规立构的、(e)半全同立构的和(f)立构嵌段。
7.如权利要求5所述的聚合物层结构物，其中使用单点催化剂得到丙烯均聚物。
8.如权利要求4所述的聚合物层结构物，其中第二密封剂层为丙烯共聚物。
9.如权利要求8所述的聚合物层结构物，其中通过使丙烯单体与具有2-20个碳的α-烯烃聚合而得到丙烯共聚物。
10.如权利要求8所述的聚合物层结构物，其中丙烯与按共聚物重量计为1％-20％的乙烯共聚合。
11.如权利要求10所述的聚合物层结构物，其中丙烯与按共聚物重量计为1％-10％的乙烯共聚合。
12.如权利要求10所述的聚合物层结构物，其中丙烯与按共聚物重量计为2％-5％的乙烯共聚合。
13.如权利要求10所述的聚合物层结构物，其中丙烯-乙烯共聚物为无规共聚物。
14.如权利要求10所述的聚合物层结构物，其中丙烯-乙烯共聚物为嵌段共聚物。
15.如权利要求13所述的聚合物层结构物，其中无规共聚物为多相的。
16.如权利要求8所述的聚合物层结构物，其中使用单点催化剂得到丙烯共聚物。
17.如权利要求1所述的聚合物层结构物，其中第二密封剂层为高熔体强度的聚丙烯。
18.如权利要求17所述的聚合物层结构物，其中高熔体强度的聚丙烯选自如下任一种：聚丙烯均聚物和聚丙烯共聚物。
19.如权利要求1所述的聚合物层结构物，其中第二密封剂层为聚丙烯和α-烯烃的共聚物的掺合物。
20.如权利要求19所述的聚合物层结构物，其中聚丙烯和α-烯烃的共聚物的掺合物根据α-烯烃中的碳数而变化。
21.如权利要求1所述的聚合物层结构物，其中封口能通过使用手压力而剥离分开。
22.如权利要求1所述的聚合物层结构物，还包括连接到第一密封剂层的第一外层。
23.如权利要求22所述的聚合物层结构物，其中第一外层选自如下任一种：(1)聚烯烃、(2)聚酰胺、(3)聚酯、(4)与下列一种或多种单体共聚合的乙烯，所述单体包括：(a)具有2-20个碳的羧酸和(b)所述羧酸的酯衍生物、(c)丙烯酸、(d)丙烯酸的酯衍生物、(e)烷基取代的丙烯酸、(f)丙烯酸的烷基取代酯、(g)乙酸乙烯酯和(h)丙烯酸乙烯酯。
24.如权利要求23所述的聚合物层结构物，其中第一外层为聚酰胺。
25.如权利要求24所述的聚合物层结构物，其中聚酰胺为尼龙6。
26.如权利要求22所述的聚合物层结构物，还包括连接到第二密封剂层的第二外层。
27.如权利要求26所述的聚合物层结构物，其中第二外层选自如下任一种：(1)聚烯烃、(2)聚酰胺、(3)聚酯、(4)与下列一种或多种单体共聚合的乙烯，所述单体包括：(a)具有2-20个碳的羧酸和(b)所述羧酸的酯衍生物、(c)丙烯酸、(d)丙烯酸的酯衍生物、(e)烷基取代的丙烯酸、(f)丙烯酸的烷基取代酯、(g)乙酸乙烯酯和(h)丙烯酸乙烯酯。
28.如权利要求27所述的聚合物层结构物，其中第二外层为聚酰胺。
29.如权利要求28所述的聚合物层结构物，其中聚酰胺为尼龙6。
30.如权利要求1所述的聚合物层结构物，其中当以与封口方向平行的方向对封口施加拉力时，封口具有0.5N-7.6N的强度。
31.如权利要求30所述的聚合物层结构物，其中当比较正进行蒸汽压热过程的结构和在121℃下进行蒸汽压热过程1小时后的结构时，封口强度的变化不超过50％。
32.如权利要求27所述的聚合物层结构物，其中第二外层为聚烯烃。
33.如权利要求32所述的聚合物层结构物，其中聚烯烃是线性低密度聚乙烯。
34.一种外袋容器，包括：
具有乙烯均聚物的第一密封剂层的第一侧壁，和
具有含丙烯聚合物的第二密封剂层的第二侧壁，该第二密封剂层沿可剥离的周边封口连接到第一密封剂层。
35.如权利要求34所述的外袋容器，其中乙烯均聚物选自如下任一种：高密度聚乙烯、中密度聚乙烯和线性低密度聚乙烯。
36.如权利要求35所述的外袋容器，其中第一密封剂层为高密度聚乙烯。
37.如权利要求34所述的外袋容器，其中第二密封剂层选自如下任一种：丙烯均聚物和丙烯共聚物。
38.如权利要求37所述的外袋容器，其中第二密封剂层为丙烯均聚物。
39.如权利要求38所述的外袋容器，其中丙烯均聚物具有选自如下任一立体化学结构：(a)非晶形的、(b)全同立构的、(c)间同立构的、(d)无规立构的、(e)半全同立构的和(f)立构嵌段。
40.如权利要求38所述的外袋容器，其中使用单点催化剂得到丙烯均聚物。
41.如权利要求37所述的外袋容器，其中第二密封剂层为丙烯共聚物。
42.如权利要求41所述的外袋容器，其中通过使丙烯单体与具有2-20个碳的α-烯烃聚合而得到丙烯共聚物。
43.如权利要求41所述的外袋容器，其中丙烯与按共聚物重量计为1％-20％的乙烯共聚合。
44.如权利要求43所述的外袋容器，其中丙烯与按共聚物重量计为1％-10％的乙烯共聚合。
45.如权利要求43所述的外袋容器，其中丙烯与按共聚物重量计为2％-5％的乙烯共聚合。
46.如权利要求43所述的外袋容器，其中丙烯-乙烯共聚物为无规共聚物。
47.如权利要求43所述的外袋容器，其中丙烯-乙烯共聚物为嵌段共聚物。
48.如权利要求46所述的外袋容器，其中无规共聚物为多相的。
49.如权利要求41所述的外袋容器，其中使用单点催化剂得到丙烯共聚物。
50.如权利要求34所述的外袋容器，其中第二密封剂层为高熔体强度的聚丙烯。
51.如权利要求50所述的外袋容器，其中高熔体强度的聚丙烯选自如下任一种：聚丙烯均聚物和聚丙烯共聚物。
52.如权利要求34所述的外袋容器，其中第二密封剂层为聚丙烯与α-烯烃共聚物的掺合物。
53.如权利要求52所述的外袋容器，其中丙烯共聚物根据α-烯烃中的碳数而变化。
54.如权利要求34所述的外袋容器，其中封口能通过使用手压力而剥离分开。
55.如权利要求34所述的外袋容器，还包括连接到第一密封剂层的第一外层。
56.如权利要求55所述的外袋容器，其中第一外层选自如下任一种：(1)聚烯烃、(2)聚酰胺、(3)聚酯、(4)与下列一种或多种单体共聚合的乙烯，所述单体包括：(a)具有2-20个碳的羧酸和(b)所述羧酸的酯衍生物、(c)丙烯酸、(d)丙烯酸的酯衍生物、(e)烷基取代的丙烯酸、(f)丙烯酸的烷基取代酯、(g)乙酸乙烯酯和(h)丙烯酸乙烯酯。
57.如权利要求56所述的外袋容器，其中第一外层为聚酰胺。
58.如权利要求57所述的外袋容器，其中聚酰胺为尼龙6。
59.如权利要求55所述的外袋容器，还包括连接到第二密封剂层的第二外层。
60.如权利要求59所述的外袋容器，其中第二外层选自如下任一种：(1)聚烯烃、(2)聚酰胺、(3)聚酯、(4)与下列一种或多种单体共聚合的乙烯，所述单体包括：(a)具有2-20个碳的羧酸和(b)所述羧酸的酯衍生物、(c)丙烯酸、(d)丙烯酸的酯衍生物、(e)烷基取代的丙烯酸、(f)丙烯酸的烷基取代酯、(g)乙酸乙烯酯和(h)丙烯酸乙烯酯。
61.如权利要求60所述的外袋容器，其中第二外层为聚酰胺。
62.如权利要求61所述的外袋容器，其中聚酰胺为尼龙6。
63.如权利要求34所述的外袋容器，其中当以与封口方向平行的方向对封口施加拉力时，封口具有0.5N-7.6N的强度。
64.如权利要求63所述的外袋容器，其中当比较正进行蒸汽压热过程的结构和在121℃下进行蒸汽压热过程1小时后的结构时，封口强度的变化不超过50％。
65.如权利要求60所述的外袋容器，其中第二外层为聚烯烃。
66.如权利要求65所述的外袋容器，其中聚烯烃是线性低密度聚乙烯。
CNB2004800026843A 2003-01-24 2004-01-26 可剥离的外袋薄膜 Expired - Lifetime CN100427043C (zh)

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CA2513678A1 (en) 2004-08-12
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EP1585451A1 (en) 2005-10-19
BRPI0406891A (pt) 2006-01-03
CN1741771A (zh) 2006-03-01
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JP4533885B2 (ja) 2010-09-01
AU2004207584A1 (en) 2004-08-12
KR20050098254A (ko) 2005-10-11
MXPA05007794A (es) 2005-09-30
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