CN101918207A - 显窃启压入式包装 - Google Patents

显窃启压入式包装 Download PDF

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CN101918207A
CN101918207A CN2009801022077A CN200980102207A CN101918207A CN 101918207 A CN101918207 A CN 101918207A CN 2009801022077 A CN2009801022077 A CN 2009801022077A CN 200980102207 A CN200980102207 A CN 200980102207A CN 101918207 A CN101918207 A CN 101918207A
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layer
tamper
packaging
pressed
polymer
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G·丰纳泰
T·马尔菲特
E·伯热斯
K·柏森斯
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Amcor Flexibles Transpac BVBA
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Abstract

本发明涉及防止欺骗性再使用的显窃启压入式包装，它包括：含至少一个小窝的聚合物基片(1)；覆盖所述小窝的多层覆盖膜(2)，所述多层覆盖膜(2)在其密封侧上包括共挤出的聚合物膜，所述共挤出的聚合物膜包括在基片上通过永久密封和可剥离的保护聚合物层(4)密封的压入式聚合物层(3)，层(3，4)二者的聚合物不相容且彼此直接接触，没有夹层，在所述压入式聚合物层(3)和所述可剥离的保护聚合物层(4)之间的粘合力低于所述聚合物基片(1)和所述压入式聚合物层(3)之间的密封强度，其中在使用中，在除去覆盖小窝的一部分压入层(3)之后，压入层离开密封接缝(6)，和其中通过在所述密封接缝(6)上的热封工艺，不可能再密封所述保护层(4)。

Description

显窃启压入式包装
发明领域
本发明涉及包装，尤其具有多层覆盖(lidding)膜的用于医疗器件的包装，所述覆盖膜包括保护性可剥离聚合物层和压入式(push-through)聚合物层的共挤出结合体；这两层聚合物层不相容且在没有任何粘合层的情况下直接接触，和使包装没有遭受欺骗再使用的危险，因为这些聚合物不相容，不可能通过加热来再密封各层。
现有技术的描述
用于医疗器件的各种包装包括可热封、可剥离的覆盖膜，所述膜在开启之后可再次热封。尽管因为这些包装容易开启，优选这些类型的包装，但当今欺骗性再使用的危险成为问题。在预填充注射器的情况下，例如通过恶意的个体再填充和再包装构成了主要的公共健康危险。
本发明公开了在使用之后防止加热再密封，但容易开启的包装材料，因为不要求切割工具。除了通过热封不可再密闭的主要安全特征以外，还可预见提供窃启证据的其他特征，例如压入层和可剥离保护层之间的颜色或外表(aspects)的差别。
文献US5522506公开了一种压入式容器，它包括由具有填料以调节其机械性能的聚烯烃或聚酯基层制成的覆盖膜。添加填料，以便降低压入膜的弹性。因此，内容物可容易地压入该膜。
文献EP0959020公开了一种防操纵(manipulation-proof)包装，它具有含压入式塑料层、连接第三抗压入顶层的可剥离粘合层的覆盖膜，所述压入层的特定组成描述于US5522506中。
文献DE19613959公开了一种包装，其中覆盖膜包括撕开(pull-off)保护层，所述撕开层通过粘合剂可剥离层，可剥离地连接到压入层上，和所述压入层通过密封层连接到基片上。
文献US5172812公开了一种带盖(lidding)容器，它包括通过在纸板片材上的可剥离粘合剂层压的压入层。
在DE19613959、EP0959020和US5172812中，在保护和压入层之间存在粘合层使之通过标准的热封方法可密封。此外，为了实现两层之间的可剥离性，通常添加具有所需剥离强度的额外层。文献US6006913公开了这种可剥离层的组合物。另一可能性是使用可剥离粘合剂。
文献US2005/0003155公开了制备显窃启(tamper-evident)包装的共挤出结构，其中内层的Z撕裂强度低于密封该包装所使用的压敏粘合剂的粘合强度，以便通过开启包装部分破坏这一内层，和这一内层从共挤出结构的外层中部分脱层。再者，若这一包装不可能通过简单的压力再密封，则可通过热封工艺再密封它，因此没有遭受欺骗再使用的危险。
附图简述
图1表示本发明包装的截面视图，所述包装具有通过借助开口辅助设备5剥离，除去保护聚合物层4，在热成形基片1上残留的压入层3的初步步骤。
图2表示在剥离保护层4和除去压入层碎片之后，本发明包装的截面视图，层3和4基本上由不相容的聚合物制成且在残留的压入层残渣6上不可能再次热封。
图3表示含保护聚合物层4和压入式聚合物层3的共挤出结构的截面视图，其中层3和4二者的聚合物不相容。
图4表示含额外的共挤出或层压层8，7的多层覆盖膜的截面视图。
图5表示内部具有注射器的本发明的密闭包装。
图6和7表示剥离掉透明保护聚合物层4的工序，压入式聚合物层3也是透明的且在该图中不可见。
图8表示用手指在压入式聚合物层3上推动，部分剥离保护聚合物层4之后的包装。
图9表示从本发明的包装中取出注射器。
图10表示具有压入式聚合物层3的包装，所述压入式聚合物层3的颜色/外表不同于开启之前的保护聚合物层4。
图11表示具有压入式聚合物层3的包装，所述压入式聚合物层3的颜色/外表不同于开启并除去压入层之后的保护聚合物层4，其中压入层碎片6残留在基片1上(密封接缝)。
发明目的
本发明目的是提供显窃启压入式包装，它防止通过热封工艺的常规方式欺骗加热再密封。
发明概述
本发明公开了防止欺骗性再使用的显窃启压入式包装，其包括：
-含至少一个小窝(pocket)的聚合物基片(web)；
-覆盖所述小窝的多层覆盖膜，所述多层覆盖膜在其密封侧上包括共挤出聚合物膜，所述共挤出的聚合物膜包括通过永久密封密封在基片上的压入式聚合物层和可剥离的保护聚合物层，这两层中的聚合物不相容，且在没有中间层的情况下彼此直接接触，所述压入式聚合物层和所述可剥离的保护聚合物层之间的粘合力低于所述聚合物基片和所述压入式聚合物层之间的密封强度，其中，在使用中，在除去覆盖小窝的一部分压入层之后，压入层留下了密封接缝，和其中在所述密封接缝上，不可能通过热封工艺再密封所述保护层。
本发明的尤其优选的实施方案包括下述特征的至少一个或任何合适的结合：
-多层覆盖膜包括至少一层额外的层；
-至少一层额外的层选自纸张、金属和聚合物；
-根据ASTM F88-00测量的所述压入层和所述保护层之间的粘合力为0.3N/15mm-3.5N/15mm；
-根据ASTM F1306-90测量的压入层的抗穿刺力为0.6N-7N；
-根据ASTM F1306-90测量的压入层的抗穿刺力为1.4N-4N；
-压入层的厚度低于20微米；
-压入层的厚度低于15微米；
-压入聚合物层和可剥离的保护聚合物层中的不相容的聚合物的结合体选自PETG/PP嵌段共聚物、PETG/LDPE、乙烯-丙烯嵌段共聚物/PETG、MDPE/PP、MDPE/PETG和EMA/PA；
-压入式聚合物层包括无机填料；
-压入式聚合物层具有不同于保护聚合物层的另一颜色和/或外表。
发明详述
本发明利用共挤出的不相容聚合物层之间的低粘合力的优点。
本发明的包装包括塑料基片1，优选热成形和多层的覆盖膜2。所述覆盖膜2包括在没有任何粘合剂中间层的情况下共挤出的至少两层不相容聚合物的至少一种共挤出结构。不存在这种粘合剂中间层使得在共挤出之后赋予充足的粘合性，以维持在产品的货架寿命期间膜的完整性，但在剥离之后使得所述粘合力太低，以致于不允许再密封。
覆盖膜中的压入层3与基片相容且必须基本上从相同的聚合物族中选择，以便它可通过在所述基片1上热封来密封，从而形成含有例如医疗器件的密闭小窝，所述压入层3具有可通过压入接近所述医疗器件的厚度与组成。
为了容易开启包装，一部分覆盖膜2可保持未密封，从而产生开口辅助设备5，以便使用者可用手指抓握所述开口辅助设备并剥离掉保护聚合物层4。
保护聚合物层4可容易地从所述压入式聚合物层3上剥离掉。层3和4之间的剥离强度使得在没有撕裂压入式聚合物层4的情况下可容易剥离。
这一保护聚合物层4与可能的额外的共挤出或层压层一起提供所需的机械性能，以满足其保护功能和视需要对氧气/水的阻挡。
通过使用共挤出技术，实现压入式聚合物层3和保护层4之间所要求的剥离强度。共挤出聚合物层A和聚合物层B(其中A和B是具体的不相容的聚合物类型)提供所需的剥离强度。
尽管本领域的技术人员常常使用不相容聚合物的定义，但在科技社团中不是只有一个意义，一些作者定义它为不混溶聚合物，其他人则通过界面张力或界面粘合水平来定义。在本发明文献的下述段落中的定义要理解为不相容聚合物的含义。
当混合物的自由能(ΔGmix)大于或等于0时，两种聚合物被说成是不混溶。
当两种聚合物的混合物的自由能大于或等于0时，当可观察到配对(partners)中各自的玻璃化转变温度(Tg)改变时，当该混合物的Flory-Huggins参数X(chi)低但大于0时，和当界面张力低时，这两种聚合物被说成是不混溶但相容。界面张力与Flory-Huggins参数X(chi)的平方成正比，当它在0-2mN/m之间时，被视为“低”。
当两种聚合物的混合物的自由能大于或等于0时，当观察不到配对中各自的玻璃化转变温度(Tg)的改变时，当该混合物的Flory-Huggins参数X(chi)大于0时，和当表面质量高时，两种聚合物被说成是不混溶且不相容。界面张力与Flory-Huggins参数X(chi)的平方成正比，当它大于2mN/m之间时，被视为“高”。
压入和保护层3和4不混溶且不相容，以其“共挤出层状态”充分地粘合到彼此上，但一旦剥离且进行热封试验，则没有提供充足的密封强度。
当通过使用覆盖膜开口辅助设备5打开包装时，所述压入式聚合物层3在密封处断裂且保护聚合物层4开始剥离(参见图1)。一旦保护聚合物层4被剥离，则压入仍然完整且覆盖被包装物品的压入式聚合物层3，以便可接近被包装的物品。
由于使用共挤出技术，因此可避免额外施加可剥离的粘合层。根据这一共挤出技术，还可产生非常薄的压入式聚合物层3。可容易地实现低于20微米，优选15微米或甚至10微米的厚度，和这一低厚度对于压入的容易程度来说是有利的。在实践中，层压这种膜厚极端困难。
这一薄的压入式聚合物层3的性质与厚度优选使得：
-它提供对共挤出的保护聚合物层4所需的剥离强度(不相容性)；
-它可非常容易地断裂；
-它可热封在基片1上(坚固地密封)，不要求额外的热封清漆。
实施例
下述实施例仅仅是为了阐述本发明的包装。
基片1是含例如基于PETG、PET-GAG、APET、PVC、PP、尼龙//PE、PP/PE、PETG//PE、APET/PE等等的一层或多层的普通塑料片。这一类型的基片广泛地用于包装医疗器件、注射器和类似物。
多层覆盖膜2包括可剥离的共挤出膜和在一侧上的至少一层压入式聚合物层3与在另一侧上的保护聚合物层4。可单独使用两层共挤出膜(3，4)(图3)或者与进一步额外的层结合(图4)。
可通过共挤出特定类型的聚合物，实现在压入式聚合物层3和保护层4之间的所需的剥离强度。导致所需的层间粘合性的不相容聚合物结合体的实例是PETG/PP、PE/APET、APET/PE、PETG/PE、PE/PETG、PE/PA、PE/PP、PP/PE、EMA/PA。重要的是此处强调在层3和4之间没有衔接层的情况下生产这些结构。它们不具有夹层。
在压入式聚合物层3和保护聚合物层4之间180°剥离强度在0.3-3.5N/15mm之间变化。
在最大25微米和优选最大20微米的膜厚下，根据ASTM F1306-90测量的压入层的抗穿刺性应当低于7N/8mm2，优选低于4N/8mm2。
取决于压入式聚合物层3的性质与厚度，可添加一定量的填料，以便使所述层得到所需的断裂性能，例如如US5522506中所公开的。当压入式聚合物层3的厚度足够低时，不需要添加这种填料。视需要，不存在填料便于维持该层的透明度。
在层3和4二者中所使用的聚合物可以是通过聚合两种或更多种共聚单体制备的以上提及的聚合物类型的无规、嵌段、交替和/或接枝聚合物，且因此包括二元聚合物、三元聚合物，例如聚乙烯和乙酸乙烯酯(EVA)、丙烯酸甲酯(EMA)、(甲基)丙烯酸的共聚物，等。
可共混以上提及的聚合物与一种或更多种其他类型的聚合物，从而提供所要求的机械/密封性能，并在层3和4之间得到所要求的粘合和可剥离性。
在共挤出保护聚合物层4具有低的软化温度(Tm或Tg)，例如LDPE或PETG的情况下，推荐共挤出或层压额外的层与具有较高软化温度的聚合物，以便能在基片1上密封多层覆盖膜2。
压入式聚合物层3优选由小于20微米的薄层制造，所述薄层既可容易断裂，又可热封在基片1上。
为了优化多层覆盖膜2的性能(抗穿刺性、抗撕裂性、耐热性、阻挡性能等)，可要求层压共挤出膜(3，4)与至少一层额外的层。在这一情况下，多层覆盖膜的结构如下所述(图4)：
-3：可容易断裂的压入式共挤出聚合物层(薄层)
-4：从压入层3上可剥离的保护性共挤出聚合物层
-7：层压或共挤出的额外层
-8：粘合层(衔接层/夹层)
与共挤出膜(3，4)一起层压的感兴趣的额外的层是OPET、OPA、PA、OPP、含铝箔的膜，含膜的纸张，等等(图4)。
为了改进覆盖膜的阻挡性能，可在这一保护膜层(OPET、OPP广泛地用于这一目的)上施加铝、氧化铝、氧化硅等的气相沉积层。关于这一点，与铝箔类型的膜一起层压也可以是感兴趣的。层压的保护膜结构7同样可以是两层或更多层的层压体本身。可使用粘合层压与基础层压二者。
由本发明要求保护的包装提供的主要安全特征是，通过常规的密封方法，不可能再密封覆盖膜2。这是因为在底部片1的密封接缝上残留压入层的残留残渣材料6。一旦打开包装和除去覆盖小窝的断裂的压入式聚合物层3，则随后不可能热封。如上所述，仅仅通过在压入式聚合物层3和保护聚合物层4内结合特定的聚合物类型，才可实现这一独特的特征。
提供显窃启的另一可能的安全特征是，使用具有不同于保护聚合物层4的另一颜色/形状的压入式聚合物层3。一旦打开包装，且压入式聚合物层3断裂和除去时，不可能重现原始包装的外表，如图10和11所示。
实施例1：
包括下述的包装：
-300微米的PETG的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-8微米的PETG(获自Eastman-Kodak的Eaststar 6763)的压入层3和
-30微米的PP嵌段共聚物(获自Borealis的RB307MO)的可剥离的保护层4。
然后，使用2K-PU粘合剂8，在PP一侧上层压共挤出物(3，4)与12微米的OPET(Mylar 800 DuPont Teijin Films)的额外层7。
实施例2：
包括下述的包装：
-300微米的PP的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-5微米的乙烯-丙烯嵌段共聚物(获自Borealis的RD735CF)的压入层3
-35微米的PETG(获自Eastman-Kodak的Eaststar 6763)的可剥离的保护层4。
然后，使用2K-PU粘合剂8，在PETG一侧上层压共挤出物(3，4)与15微米的OPA(获自Honeywell的Capran1200)的额外层7。
实施例3：
包括下述的包装：
-240微米的APET/PE的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-10微米的MDPE(获自ExxonMobil的LD 151BW)的压入层3
-40微米的PP嵌段共聚物(获自Borealis的BB213CF)的可剥离的保护层4。
然后，使用2K-PU粘合剂8，在PP一侧上层压共挤出物(3，4)与12微米的OPET(获自DuPont Teijin Films的Mylar 800)的额外层7。
实施例4：
包括下述的包装：
-240微米的PV的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-10微米的含30％碳酸钙的乙烯和甲基丙烯酸酯共聚物(获自Dupont的Elvaloy 1218AC)的压入层3
-40微米的PA(获自DSM的Akulon F132-F)的可剥离的保护层4。
没有进一步层压覆盖膜，因为聚酰胺层已经具有较高的熔融温度。
实施例5：
包括下述的包装：
-240微米的PETG的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-15微米的PETG(获自Eastman的Eaststar 6763)的压入层3
-50微米的LDPE(获自Sabic的Sabic 2201 TH00)的可剥离的保护层4。
然后，使用2K-PU粘合剂8，在LDPE一侧上层压共挤出物(3，4)与12微米的AlOx涂布的取向PET(获自AMCOR-Camvac的CamclearRHB-Y)的额外层7。
实施例6：
包括下述的包装：
-300微米的PETG/PE的热成形的塑料基片1
-含共挤出膜的多层覆盖膜2，所述共挤出膜通过共挤出下述而获得：
-20微米的99％MDPE(获自ExxonMobil的LD 151BW)+1％母炼胶红色颜料(获自Schulman的Polybatch 5020)的压入层3
-30微米的PETG(获自Eastman的Eaststar 6763)的可剥离的保护层4。
然后，使用2K-PU粘合剂8，在PETG一侧上层压共挤出物(3，4)与12微米的铝箔层压体(获自Hydro Aluminium)和12微米的取向PET(Mylar 800 DuPont Teijin Films)的额外层7。
制备包装、试验方法和试验结果
在Multivac包装机上热成形基片1(6×13cm，1.5cm深的包装)，并使用下述条件，在基片上密封多层覆盖膜：
-压力：0.2-.6MPa
-温度：140-180℃
-密封时间：2-8秒
压入层3和可剥离的聚合物层4的共挤出物(3，4)的性能
根据ASTM F88-00，采用下述参数，进行剥离强度测量：
-夹具分离速度：300mm/min
-尾部保持法：180°承载
-样品宽度：15mm
根据标准ASTM F1306-90，采用下述参数进行抗穿刺性测量：
-直径3.2mm的半球形(双轴应力)探针(8mm2)
-十字头速度：25mm/min
  特征  实施例1  实施例2  实施例3  实施例4  实施例5  实施例6
  层3和4之间的剥离强度(N/15mm)：180°承载   0.3   0.3   0.6   3.5   0.9*   0.75
  Push through聚合物层3的抗穿刺性(N/8mm2)   4   1.4   1.9   0.6   7   3.5
附图标记：
1.聚合物基片
2.多层覆盖膜
3.压入式聚合物层
4.保护聚合物层
5.开口辅助设备
6.在剥离和打开之后在基片上的压入残渣(残留的密封接缝)
7.在保护聚合物层(4)上层压或共挤出的额外的保护层
8.粘合层
9.密封表面

Claims (12)

1.防止欺骗性再使用的显窃启压入式包装，它包括：
-含至少一个小窝的聚合物基片(1)；
-覆盖所述小窝的多层覆盖膜(2)，所述多层覆盖膜(2)在其密封侧上包括共挤出的聚合物膜，所述共挤出的聚合物膜包括通过永久密封密封在基片上的压入式聚合物层(3)和可剥离的保护聚合物层(4)，层(3，4)二者的聚合物不相容且彼此直接接触，没有夹层，在所述压入式聚合物层(3)和所述可剥离的保护聚合物层(4)之间的粘合力低于所述聚合物基片(1)和所述压入式聚合物层(3)之间的密封强度，其中在使用中，在除去覆盖小窝的一部分压入层(3)之后，压入层留下密封接缝(6)，和其中不可能通过在所述密封接缝(6)上的热封工艺再密封所述保护层(4)。
2.权利要求1的显窃启压入式包装，其中所述多层覆盖膜(2)包括至少一层额外层。
3.权利要求2的显窃启压入式包装，其中所述至少一层额外层选自纸张、金属和聚合物。
4.前述任何一项权利要求的显窃启压入式包装，其中根据ASTMF88-00测量的所述压入层(3)和所述保护层(4)之间的粘合力为在0.3N/15mm和3.5N/15mm之间。
5.前述任何一项权利要求的显窃启压入式包装，其中根据ASTMF1306-90测量的压入式层(3)的抗穿刺性在0.6N和7N之间。
6.前述任何一项权利要求的显窃启压入式包装，其中根据ASTMF1306-90测量的压入层(3)的抗穿刺性在1.4N和4N之间。
7.前述任何一项权利要求的显窃启压入式包装，其中压入层(3)的厚度低于20微米。
8.前述任何一项权利要求的显窃启压入式包装，其中压入层(3)的厚度低于15微米。
9.前述任何一项权利要求的显窃启压入式包装，其中压入式聚合物层(3)和可剥离的保护聚合物层(4)的不相容聚合物的结合体选自PETG/PP嵌段共聚物、PETG/LDPE、乙烯-丙烯嵌段共聚物/PETG、MDPE/PP、MDPE/PETG如EMA/PA。
10.前述任何一项权利要求的显窃启压入式包装，其中压入式聚合物层(3)包括无机填料。
11.前述任何一项权利要求的显窃启压入式包装，其中压入式聚合物层(3)具有不同于保护聚合物层(4)的另一颜色和/或外表。
12.前述任何一项权利要求的显窃启压入式包装，其中压入层(3)和基片(1)的聚合物之间的相容性将确保甚至在除去覆盖所述小窝的一部分压入层之后，存在永久密封到基片(1)上的永久接缝(6)。
CN2009801022077A 2008-01-30 2009-01-28 显窃启压入式包装 Pending CN101918207A (zh)

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