出版物: 2020 年 7 月 13 日最近更新時間: 2025 年 3 月 7 日

TPE 为药品提供最优质包装材料

凯柏胶宝® 是全球公认的优质 TPE 化合物制造商，其热塑宝 M 化合物是医药包装领域的首选材料。

在包装材料开发的过程中，产品保质期一直都是最重要的考虑因素之一。药品包装尤其如此，必须确保药品在送到消费者手中之前，可以保护药品免受生物污染，始终保持产品质量。因此，药物包装材料必须符合多方面的严格要求，比如防光、防热、防潮，可确保内部的药物不会发生化学反应等。

此外，药物包装材料的设计方式应该非常灵活，必须在不增加包装重量的前提下易于处理和存储。

热塑性弹性体（TPE）等聚合物材料在药物包装领域的应用，是一个重要的发展里程碑，因为这种材料具有行业要求的性能，例如出色的紫外线防护性能、高抗冲击性强度以及耐用性。

作为全球领先 TPE 制造商，凯柏胶宝® 针对各行各业提供各类热塑性弹性体产品和定制解决方案，其生产的热塑宝 M 化合物就可以符合上述的各项要求。该系列专为医疗和制药行业开发，符合药品包装所需的各项规格。该系列符合 USP VI 级、ISO 10993-4（溶血）、ISO 10993-5（细胞毒性）、ISO 10993-10（皮内刺激性）和 ISO 10993-11（急性系统毒性）中规定的医药级塑料的国际标准。

热塑宝 M 的抗菌特性

生物污染物是导致药品变质的主要原因。热塑宝 M 化合物的优势在于：可使用 EtO 气体、过热蒸汽（134°C）、γ 射线处理（2 x 35 kGy），β 射线（电子束）处理（2 x 35 kGy）对其进行灭菌。因此，这些化合物适合制作药瓶的密封件和阀门，以及药物包装中的封盖、隔膜、瓶盖、输液盖和安瓿等。这种化合物还应用于制药行业中与转移和填充过程相关的产品。

物有所值

热塑宝 M 化合物的开发过程充分优化了产品的生产率和成本效益。这种材料不仅应用广泛，还可以进行经济高效的成型加工，在进行注塑、双组分注塑成型和挤压加工时具有周期短的优势，可帮助制造商提高生产率。此外，热塑宝 M 化合物对广泛的聚合物（例如 PP、PE、COC、ABS、PS、PC、PET 和 PA）具有极佳的包胶性。

医疗服务包提供最佳产品纯度

凯柏胶宝® 提出的“医疗服务包”达到了 TPE 化合物的最高质量标准，其中不含主动添加的重金属、乳胶、PVC 和邻苯二甲酸盐。

同样，公司专门分配独立的加工生产线，用于生产这种类型的化合物，其生产过程始终都会记录在美国 FDA 药物主文件（DMF）之中。

此外，医疗服务组合可确保 24 个月的化合物供应，保障供应安全性，可保证药品包装制造商的长期使用。

Pharmaceutical packaging in top form with TPEs

KRAIBURG TPE, a recognized global TPE manufacturer in superior TPE compounds, has packaged its THERMOLAST® M TPE compounds for pharmaceutical packaging applications.

Product shelf-life has always been the priority in the development of packaging materials. For pharmaceutical products, it is a vital feature to protect against biological contamination while maintaining the quality of the product until it reaches the consumer. Thus, the material used for pharmaceutical packaging has to meet requirements such as provide protection against light, heat, and moisture as well as ensure that there is no chemical reaction with the packaged drug.

Furthermore, the materials used in pharmaceutical packaging have to allow for design flexibility and not add extra weight to the packaging, for easy handling and storage.

The use of polymer materials such as thermoplastic elastomers (TPEs) has been an important milestone in the development of pharmaceutical packaging as they render the required properties, such as excellent barrier protection against UV light as well as feature high impact strength and durability.

Meeting these requirements, KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers its THERMOLAST® M TPE compounds. This is specially developed for the medical and pharmaceutical industry and assures the specifications required for pharmaceutical packaging. The series meets the medical grade plastics international standards set in the USP Class VI, ISO 10993-4 (haemolysis), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritations) and ISO 10993-11 (acute system toxicity).

Antimicrobial properties of THERMOLAST® M

Biological contaminants are a major cause of spoilage of pharmaceutical products. The advantage with THERMOLAST® M TPE compounds is that they can be sterilized using methods such as EtO gas, superheated steam (134°C), γ-gamma ray treatment (2 x 35 kGy), β-ray (electron beam) treatment (2 x 35 kGy). Thus, these compounds are suited for applications like seals and valves in bottles for pharmaceutical storage, as well as for closures, septum, caps, infusion caps and ampoules in pharmaceutical packaging. The compounds can also be used in applications related to the process of transfer and filling in pharmaceutical industries.

Material performance for cost

The THERMOLAST® M TPE is developed with optimum productivity and cost-effectiveness in mind. Aside from the materials’ ample range of application possibilities, other features are the cost-effective molding process and short cycle time advantage for injection and two-component injection molding and extrusion processing, which allow manufacturers to boost their productivity. As well, the THERMOLAST® M TPE show excellent adhesion to various polymers such as PP, PE, COC, ABS, PS, PC, PET and PA.

Optimum purity with the Medical Service Package

KRAIBURG TPE provides a Medical Service Package that is orientated to delivering the highest quality standards of its TPE compounds, which are free of intentionally added heavy metals, latex, PVC and phthalates.

As well, the production of the compounds is permanently assigned in a separate processing unit, with the constant manufacturing process recorded in US FDA Drug Master Files (DMF).

Furthermore, the medical service package guarantees a 24-month supply of the compounds, allowing for supply security and long-term use by pharmaceutical packaging processors.