CN107750258A - 聚乙烯材料在生产可灭菌的液体容器中的用途 - Google Patents
聚乙烯材料在生产可灭菌的液体容器中的用途 Download PDFInfo
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Abstract
本发明涉及聚乙烯材料在液体容器中的用途，这些液体容器是在>15分钟的时间段期间在≥100℃的温度下可灭菌的，其中该聚乙烯材料具有如根据ISO 1183‑1，方法A确定的>928kg/m3的密度以及如根据ISO 1133‑1确定的在190℃的温度下和2.16kg的负荷下≥0.50且51.00g/10min的熔体质量流动速率；其中该聚乙烯材料在≥1600巴的压力下在高压自由基聚合方法中生产。
Description
本发明涉及聚乙烯材料在生产在≥100℃下可灭菌的液体容器中的用途。
为了使用于医疗应用的液体容器适用于在患者(如人和动物)的治疗中安全使用，此类容器经常只使用一次并经受灭菌处理。聚合物材料并且尤其是聚乙烯由此易于在所谓的吹制-填充-密封过程(其中该液体容器尤其例如通过吹塑模制形成，填充有液体并密封)中进行处理。聚乙烯可以进一步再循环，使得其经常用于此种类应用。灭菌处理由此针对以这样的方式减少存在于物体内或上的微生物数量，即降低对经历涉及此类容器的治疗的患者的健康的任何相关风险。
例如在EP601631A1中描述了可以经历灭菌处理的用于医疗应用的液体容器。EP601631A1描述了由聚乙烯组合物制成的容器，这些聚乙烯组合物包含20-50wt％的具有915-935kg/m3的密度的线性低密度聚乙烯和50-80wt％的具有920-965kg/m3的密度的线性低密度聚乙烯。使此类容器经受在110℃下的灭菌。关于灭菌时间段没有指示呈现。此类容器的一个缺点是它们包含线性低密度聚乙烯材料，这些聚乙烯材料，由于它们的生产过程的性质，含有来源于催化剂的残余物。此类残余物可能例如包括四氢呋喃、铬、锆和/或铪。由于存在此类残余物，这些材料不适用于某些医疗应用。
另一方面，US20110120058A1描述了使用锆-茂金属催化剂制备的线性低密度聚乙烯的用途，其中该线性低密度聚乙烯具有935kg/m3的密度，由该聚乙烯制造小袋，使这些小袋经受在119℃下的灭菌持续15分钟。同样对于这些容器，缺点是它们包含再次含有来自催化剂的残余物的线性低密度聚乙烯材料。
鉴于关于有待用于医疗应用的材料的越来越严格的期望、要求和法规以保护患者的健康和安全，此类残余物变得越来越不受欢迎。
因此，显然存在对寻找新材料的持续需要，这些新材料适用于在高温下可灭菌的液体容器并满足对此类材料的苛刻期望。
这现在根据本发明通过使用聚乙烯材料用于在≥15分钟的时间段期间在≥100℃的温度下可灭菌的液体容器得以实现，
其中该聚乙烯材料具有如根据ISO 1183-1(2012)，方法A确定的≥928kg/m3的密度以及如根据ISO 1133-1(2011)确定的在190℃的温度下和2.16kg的负荷下≥0.30且≤1.00g/10min的熔体质量流动速率；
其中该聚乙烯材料在≥1600巴的压力下在高压自由基聚合方法中生产。
根据本发明的用途是优选例如用于一次性的液体容器，这些液体容器因此可能仅使用一次。此外，根据本发明的用途例如优选用于无菌包装。
如根据ISO 1183-1(2012)，方法A确定的根据本发明使用的聚乙烯材料的密度可以例如是≤950kg/m3、可替代地≤940kg/m3、可替代地≤935kg/m3、可替代地≤930kg/m3。如根据ISO 1183-1(2012)，方法A确定的根据本发明使用的聚乙烯材料的密度可以例如是≥928kg/m3。这样的密度可以例如在灭菌期间有助于良好的形状稳定性。形状稳定性可以理解为在灭菌期间液体容器或填充的液体容器的原始形状的保持。具有良好的形状稳定性的液体容器可以例如在灭菌期间不显示出热变形或持久的热变形。在灭菌期间具有良好的形状稳定性的液体容器因此可以例如优选地不展现出形状的变化，尤其是形状的持久变化，例如像形成凸起、波纹、凹陷和/或凸出和/或下垂和/或体积变化。持久的由此可以是指在灭菌之后持续和/或保持可见。具有良好的形状稳定性的液体容器可以例如优选在灭菌期间也***漏。灭菌期间良好的形状稳定性由此变得越来越重要，不仅因为美观原因，而且因为它强烈地促进了医疗人员对使该液体容器经受适当灭菌的信心和能力以及对品质治疗的信任。
如根据ISO 1133-1(2011)在190℃的温度和2.16kg的负荷下确定的根据本发明使用的聚乙烯材料的熔体质量流动速率可以例如是≤1.00g/10min、可替代地≤0.90g/10min、可替代地≤0.80g/10min、可替代地≤0.70g/10min、可替代地≤0.60g/10min。如根据ISO 1133-1(2011)在190℃的温度和2.16kg的负荷下确定的聚乙烯材料的熔体质量流动速率可以例如是≥0.30g/10min、可替代地≥0.35g/10min、可替代地≥0.40g/10min、可替代地≥0.45g/10min、可替代地≥0.50g/10min。如根据ISO 1133-1(2011)在190℃的温度和2.16kg的负荷下确定的聚乙烯材料的熔体质量流动速率可以例如是≥0.30且≤1.00g/10min、可替代地≥0.40且≤0.80g/10min、可替代地≥0.50且≤0.60g/10min。例如，此种熔体质量流动速率可以产生在吹制-填充-密封生产过程中具有良好可加工性的材料。此种熔体质量流动速率可以例如有助于在吹制-填充-密封生产过程中的型坯吹塑模制阶段中良好的可加工性和/或良好的熔体稳定性。此外，它还可以在灭菌期间有助于良好的形状稳定性。
在本发明的上下文中，液体容器可以例如是瓶、小瓶、安瓿、管、袋或小袋。例如，液体容器可以是柔性容器，例如柔性静脉注射袋或柔性静脉注射瓶，优选(预)填充有液体。液体容器可以由此例如包含例如用于患者的医疗治疗(包括例如静脉治疗)的医疗材料的液体、溶液和/或悬浮液。这些液体容器此外可以例如具有≥0.100l、可替代地≥0.200l、可替代地≥0.400l、可替代地≥0.500l的体积。此类液体容器可以例如具有≤2.000l、可替代地≤1.500l、可替代地≤1.000l、可替代地≤0.750l的体积。例如，此类液体容器可以具有≥0.100l且≤1.000l、可替代地≥0.200l且≤0.750l的体积。
根据本发明的液体容器可以例如是通过热处理可灭菌的。例如，该热处理尤其可以在蒸汽的存在下和/或在压力下、尤其是在高压釜中进行。例如，这样的压力可以在1巴与3巴之间、优选在2巴与3巴之间，进一步优选≤10巴。灭菌过程的持续时间可以例如是≥15分钟、可替代地≥30分钟、可替代地≥45分钟、可替代地≥60分钟、可替代地≥75分钟。根据本发明的液体容器可以例如是在≥100℃、可替代地≥105℃、可替代地≥110℃、优选在110℃与115℃之间、甚至更优选在110℃的温度下可灭菌的。
在这样的高温度下并且尤其例如对于≥15分钟的持续时间，形状稳定性变得越来越难以维持。根据本发明使用的材料由此已出人意料地显示出非常好的形状稳定性，甚至对于在相对高的温度下和/或长的持续时间的灭菌。
在实施例中，液体容器可以是例如预填充的。在本发明的上下文中，预填充应理解为在生产液体容器时或恰在其之后和/或在经受灭菌处理之前进行填充。预填充的液体容器可以例如通过作为其生产过程的一部分或恰在其之后填充液体容器来生产，尤其是例如在所谓的“吹制-填充-密封”方法(BFS-方法)中。在此种BFS方法中，液体容器可以通过挤出吹塑模制过程来生产，其中直接在液体容器模制时或恰在其之后，将它用液体材料填充并密封。可替代地，液体容器也可以通过挤出吹塑模制来生产并在稍后阶段填充。
根据本发明使用的聚乙烯材料可以例如是在聚合物链中包含≥90.0摩尔％、可替代地≥95.0摩尔％、可替代地≥98.0摩尔％、可替代地≥99.0摩尔％、可替代地≥99.9摩尔％的衍生自乙烯单体的结构单元的聚乙烯材料。它还可以优选例如不包含催化剂/金属残余物，例如尤其是茂金属残余物，和/或任何LLDPE。
根据本发明使用的聚乙烯材料可以优选例如在高压自由基聚合方法中生产。该聚乙烯材料可以例如在管式反应器中生产。聚乙烯可以例如在≥1600巴、可替代地≥1800巴、可替代地≥2000巴、可替代地≥2200巴、可替代地≥2400巴的压力下操作的聚合方法中生产。聚乙烯材料可以例如在自由基引发剂存在下和/或不使用催化剂和/或不使用任何含金属化合物的情况下生产。该生产方法由此例如影响聚乙烯材料的结构、结晶度和/或分子量分布，并且由此有助于在灭菌期间的良好的可加工性和非常好的形状稳定性二者。
在通过自由基高压聚合方法生产聚乙烯中，不使用包含四氢呋喃、铬、铪和/或锆的催化剂。因此，没有衍生自在聚合方法中使用的催化剂的此种残余物留在通过此种方法生产的聚乙烯中。
根据本发明的用途可以是用于例如可以包括多层的液体容器。可替代地，根据本发明的用途可以是用于优选由单层组成的液体容器。
根据本发明的用途可以是用于通过包括以下步骤的方法生产的液体容器：
a)提供包含该聚乙烯材料的熔体；
b)将该熔融材料成型为具有包括开口的形状的管状型坯；
c)将所述型坯定位在具有所述液体容器的所需形状的模具中，其中将该型坯保持在这样的温度下，即使得可以通过用加压气体对该型坯的内部加压将该型坯成型为该液体容器的形状，以形成具有至少一个开口的液体容器；
d)任选地冷却该液体容器，
e)使用用于患者的医疗治疗的液体产品填充该液体容器；以及
f)密封该液体容器的该至少一个开口
其中可以使该液体容器经受在≥15分钟的时间段期间在≥100℃的温度下的灭菌处理。
所述熔体由此可以通过使该聚乙烯材料经受熔体挤出过程来提供。所述型坯可以例如通过将来自该熔体挤出过程的熔融材料进料到具有该型坯形状的模具中来生产。该加压气体可以是无菌和/或医疗级气体。
根据本发明的用途可以是用于具有≤200μm、可替代地≤150μm、可替代地≤100μm的壁厚的液体容器。例如，此种层可以具有≥20μm、可替代地≥50μm的厚度。例如，此种层可以具有≥20且≤150μm、可替代地≥50且≤100μm的厚度。
根据本发明的用途可以是用于通过一种方法生产的液体容器，在该方法中密封步骤f)通过以下方式进行：
·将该液体容器的开口区域中的材料加热至高于软化温度的温度以提供软化的材料区域；
·通过使该液体容器的软化的材料进行使得该开口闭合的接触来密封该开口；以及
·将该软化的材料冷却到低于该软化温度的温度。
本发明将通过以下非限制性的实例进一步说明。
在Rommelag Bottlepack 321吹制-填充-密封机器上，以与实例I和II相同的方式制备液体容器。唯一的区别因此在于所使用的材料。
实例I是根据本发明进行的；为了比较目的，使用聚乙烯材料进行实例II。
| 实例 | I | II(对比) |
| 聚乙烯材料 | PE-A | PE-B |
| 密度 | 928kg/m3 | 927kg/m3 |
| 熔体质量流动速率 | 0.55g/10min | 0.30g/10min |
| 灭菌期间中的形状稳定性 | 良好的 | 差的；凸起/波纹出现 |
PE-A是可从沙特基础工业公司(SABIC)获得的等级 LDPE PCG06的聚乙烯，其是在2800巴的压力下在管式高压自由基聚合方法中生产；PE-B是可从利安德巴塞尔工业公司(LyondellBasell)获得的等级PE3020D的聚乙烯。
密度根据ISO 1183-1(2012)确定，涉及确定非泡沫塑料的密度的方法，使用方法A。
熔体质量流动速率根据ISO 1133-1(2011)确定，涉及在190℃的温度和2.16kg负载下确定热塑性塑料的熔体质量流动速率和熔体体积流动速率。
灭菌时的形状稳定性是通过使由实例I和II获得的液体容器经受用蒸汽在高压釜中在106℃的温度下持续85分钟的灭菌处理来确定的。在该灭菌处理之后，已目视评估灭菌期间中的形状稳定性。
所呈现的实例示出，使用以下聚乙烯材料来生产在≥100℃下可灭菌的液体容器可以出人意料地产生显著增加的灭菌期间的形状稳定性(与使用经常用于此类应用并且另外具有非常相似的特性的工业标准材料相比)，该聚乙烯材料具有如根据ISO 1183-1(2012)，方法A确定的≥928kg/m3的密度以及如根据ISO 1133-1(2011)在190℃的温度和2.16kg的负荷下确定的≥0.30且≤1.00g/10min的熔体质量流速，在≥1600巴的压力下在高压自由基聚合方法中生产。
Claims (11)
1.聚乙烯材料在液体容器中的用途，这些液体容器是在≥15分钟的时间段期间在≥100℃的温度下可灭菌的，
其中该聚乙烯材料具有如根据ISO 1183-1(2012)，方法A确定的≥928kg/m3的密度以及如根据ISO 1133-1(2011)确定的在190℃的温度下和2.16kg的负荷下≥0.50且≤1.00g/10min的熔体质量流动速率；
其中该聚乙烯材料在≥1600巴的压力下在高压自由基聚合方法中生产。
2.根据权利要求1所述的用途，其中该液体容器是瓶或静脉注射袋。
3.根据权利要求2所述的用途，其中该液体容器是预填充的。
4.根据权利要求1至3权利要求2中任一项所述的用途，其中该用途是用于在≥105℃或≥110℃的温度下可灭菌的液体容器。
5.根据权利要求1至4中任一项所述的用途，其中该用途是用于在≥60分钟的时间段期间可灭菌的液体容器。
6.根据权利要求1至5中任一项所述的用途，其中该用途是用于用BFS方法生产的液体容器。
7.根据权利要求1至6中任一项所述的用途，其中该用途是用于由单层组成的液体容器。
8.根据权利要求1至7中任一项所述的用途，其中该用途是用于一次性的液体容器。
9.根据权利要求1至8中任一项所述的用途，其中该用途是用于通过包括以下步骤的方法生产的液体容器：
a)提供包含该聚乙烯材料的熔体；
b)将该熔融材料成型为具有包括开口的形状的管状型坯；
c)将所述型坯定位在具有所述液体容器的所需形状的模具中，其中将该型坯保持在这样的温度下，即使得可以通过用加压气体对该型坯的内部加压将该型坯成型为该液体容器的形状，以形成具有至少一个开口的液体容器；
d)使用用于静脉治疗的产品填充该液体容器；以及
e)密封该液体容器的该至少一个开口。
10.根据权利要求9所述的用途，其中该用途是用于通过一种方法生产的液体容器，在该方法中密封步骤f)通过以下方式进行：
·将该液体容器的开口区域中的材料加热至高于软化温度的温度以提供软化的材料区域；
·通过使该液体容器的软化的材料进行使得该开口闭合的接触来密封该开口；以及
·将该软化的材料冷却到低于该软化温度的温度。
11.根据权利要求1至10权利要求9中任一项所述的用途，其中该聚乙烯材料在管式反应器中制造。
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