出版物: 2020 年 4 月 14 日最近更新時間: 2025 年 3 月 10 日

TPE——有效提高呼吸装置性能的重要材料

凯柏胶宝® 是优质 TPE 化合物领域公认的全球领军企业，公司提供的热塑宝 M 系列化合物是制造医用呼吸机、呼吸装置和呼吸治疗设备的理想材料。

随着呼吸治疗设备的发展，先进的技术对呼吸系统疾病的预防和治疗效果在明显增强。呼吸系统疾病在全球的流行趋势有增无减，医疗诊治需要更高效的设备来清除患者呼吸道中的粘液，改善患者的肺部功能。而并非任何呼吸治疗设备都可以达到期望的效果，其中，设备制造采用的材料差异便是影响其功能的重要环节。

热塑性弹性体（TPE）材料的独特性能使其更适合医疗领域的应用，尤其是用于制作呼吸机和呼吸治疗设备。TPE材料的优势包括：表面摩擦力小、密封性强、触感柔软、弹性强、耐用性高和理想的包胶性能，非常适合制作医用吸入器的面罩、气囊面罩、吹嘴、管材和呼吸辅助器的连接器等。

凯柏胶宝® 是全球领先的 TPE 制造商，为各行各业提供类型多样的热塑性弹性体产品和定制解决方案。其中我们的优质热塑宝 M 系列定制材料适用于医疗领域所需的多种诊治和制药设备。

消毒和安全性能满足医用要求

热塑宝 M 系列化合物可通过 121°C 或 134°C 高热蒸汽、γ-γ射线处理（2 x 35 kGy）、β 射线（电子束）处理（2 x 35 kGy）和 EtO 方法进行气体灭菌。该系列所有化合物不含乳胶、PVC 和邻苯二甲酸盐，生产过程中无重金属，为医疗应用领域的安全性提供了保障。

此外，热塑宝 M 化合物具有出色的耐用性、柔韧性和高弹性，可用于制作挠性连接器、隔膜、密封件和阀门以及呼吸治疗设备，例如氧气管、雾化器管、气雾面罩、吹嘴、柔性连接器、便携式雾化器、阀门（咬嘴）和鼻腔冲洗器（盖和连接器）。

通过多组分注塑成型技术，热塑宝 M 系列对多种聚烯烃（如 PP、PE、COC 和 COP）和技术热塑性塑料（如 ABS、PC、PET-G 和聚酰胺）具有极佳的包胶性。该系列化合物可采用注塑和挤出工艺进行加工，具有出色的压缩永久变形特性。

热塑宝M系列化合物外观通常为彩色透明或半透明状态。同时，凯柏胶宝® 也提供特色需求的着色和颜色匹配服务，所有化合物都可以根据客户要求进行定制着色。

安全证明

该系列 TPE 产品符合德国工程师协会 (VDI) 针对医用级塑料 (MGP) 制定的 VDI 2017 准则要求以及 Reach 和 RoHS 规定。系列中所有化合物经检测符合以下各项标准要求：DIN ISO 10993-5 细胞毒性、DIN ISO 10993-4 溶血和间接血液接触、DIN ISO 10993-10 皮肤内刺激性和 DIN ISO 10993-11 急性系统毒性。属于 USP VI 抽取级别。

出色的客户满意度

凯柏胶宝® 凭借独家全方位服务包确保最高产品标准。该服务包以客户需求为第一考量：在药品主文件 (DMF) 中持续记录制造过程；要求供应商承诺保证 24 个月供应安全性和原材料纯度；另外，为热塑宝 M 系列产品配置专用生产单元、独立产线，以此确保 TPE 的质量、安全性和可靠性。

TPE as a key material factor for more potent respiratory devices

KRAIBURG TPE, a recognized global leader in superior TPE compounds, offers a range of THERMOLAST® M TPE compounds for medical ventilator, respirator and breathing therapy devices applications.

Technological advancement in respiratory care devices results in enhanced preventive and treatment outcomes. With the increasing global prevalence of respiratory conditions, demand for devices that help the removal of mucus from the airways and aid in improving pulmonary function is also growing. Yet, not all respiratory and breathing therapy devices are created equal and their material composition makes all the difference.

Thermoplastic elastomers materials or TPEs yield properties suited for medical applications, specifically for respirator and breathing therapy devices. Such benefits include low surface friction, good sealing, soft touch, elasticity, durability, and good adhesion that are ideal for use in medical inhaler mask, bag valve mask, mouthpieces, tubing, and connectors for respiratory aids.

KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers high-quality custom engineered THERMOLAST® M TPE materials for applications in medical and pharmaceutical devices used in healthcare facilities.

Sterilizability, safety adherence in medical applications

The THERMOLAST® M series compounds are sterilizable with superheated steam of 121°C or 134°C, γ-gamma ray treatment (2 x 35 kGy), β-ray (electron beam) treatment (2 x 35 kGy) and EtO gas. Safe to use in medical applications, these compounds are free of latex, PVC, and phthalates, and they are produced without the use of heavy metals.

Additionally, the THERMOLAST® M compounds possess excellent durability, flexibility and high elasticity that are suitable for use in flexible connectors, membranes, seals and valves as well as for breathing therapy devices such as oxygen tube, nebulizer-tubing, aerosol mask, mouthpiece, flexible connectors, portable nebulizer, valve (mouthpiece), and nasal douche (lid & connector).

THERMOLAST® M series has excellent adhesion to a range of polyolefins such as PP, PE, COC and COP; and technical thermoplastics such as ABS, PC, PET-G, as well as polyamides by multi-component injection molding. The compounds can be processed through injection molding and extrusion, and have excellent compression set characteristics.

These compounds are usually transparent or translucent in color. However, as KRAIBURG TPE offers services on coloration and color matching to individual color samples, all compounds can likewise be obtained in any given color.

Evidence of Safety

The TPE series meets the requirements of the VDI 2017 guideline for medical grade plastics (MGPs) issued by the Association of German Engineers (VDI), as well as the Reach and RoHS standards. The compounds are tested according to DIN ISO 10993-5 Cytotoxicity; DIN ISO 10993-4 Haemolysis, indirect blood contact; DIN ISO 10993-10 Intracutaneous irritation and DIN ISO 10993-11 Acute system toxicity; USP Class VI Extraction.

Customer satisfaction at the fore

KRAIBURG TPE strives to maintain the standards of its products by providing a unique service package that focuses on our customer needs in constantly recording manufacturing process in the drug Masterfile (DMF); and by guaranteeing 24-month supply security and purity of our raw materials through the commitment of our suppliers and a dedicated production unit for THERMOLAST® M to ensure the quality, safety and reliability of our TPEs.