出版物: 2020 年 5 月 4 日最近更新時間: 2025 年 3 月 10 日

专用于医疗领域直接接触血液和体液的 TPE

热塑宝 M 系列具有重新密封、低表面摩擦和高弹性的优良特性

凯柏胶宝® 是全球顶级 TPE 化合物制造专家，公司的医用级塑料品牌热塑宝 M 提供各式各样的 TPE 化合物，它们是专为在医疗领域中直接接触血液和体液而研发的材料。

当今的新型疾病需要更严格的处理，从而阻止疾病传播，或将其影响控制在最小范围。作为感染控制的关键，人们必须严格遵守处理血液和体液——作为病原体潜在载体——的规程。同样，为了应对治疗新型疾病的复杂性，静脉采注的药物递送系统也要不断升级。

热塑性弹性体或 TPE 等医疗级塑料材料的应用，表明医疗设备需要优越的性能、安全性和耐用性，来确保遵守规程和医疗手段的效力。因此，TPE 为医疗设备和配件制造商界定了原材料规格。

凯柏胶宝® 是全球领先 TPE 制造商，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，公司致力于提供定制工艺的高品质热塑宝 M 系列化合产品，可应用于各种医疗器械，包括直接接触血液和体液的管理产品。

发挥 TPE 的材料优势

热塑宝 M 系列具有重新密封、低表面摩擦和高弹性的优良特性；硬度范围为 60VLRH（超软）至 50Sh D（半刚性），适用于集血器盖密封、输液盖，并能广泛用于输液泵配药系统密封、注射器活塞、输液器密封塞、导尿管帽、月经杯和软管。

安全证明

热塑宝 M 系列化合物不含动物源性成分、乳胶、PVC 和邻苯二甲酸盐。

产品在制造过程中未使用重金属，并经过 134°C 高压灭菌器、2x35 kGy 伽马射线和环氧乙烷灭菌消毒灭菌。

此外，该系列的 TPE 产品还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。这些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® 通过独家全方位服务确保最高产品标准。我们的服务包以客户需求为第一考量，不断在药品主文件 (DMF) 中记录制造过程。我们的供应商承诺保证 24 个月供应安全性和原材料纯度。热塑宝 M 系列产品有自己的专用生产单元，以此确保 TPE 的质量、安全性和可靠性。

TPEs for direct contact with blood and body fluid applications in the medical sector

The THERMOLAST® M series offers the advantages of resealing, low surface friction and high elasticity.

KRAIBURG TPE, a global specialist in superior TPE compounds, offers a range of TPE-compounds of its medical grade plastics brand THERMOLAST® M. These are designed for direct contact with blood and body fluid applications in the medical sector.

New emerging diseases are requiring more stringent handling to deter their spread or minimize their impact. As key to infection control, protocols for handling blood and body fluid, as potential carriers of pathogens, are strictly followed. As well, drug delivery systems, which are adopted intravenously, are also continuously upgraded to be on par with the complexities of treating new diseases.

Medical-grade plastic materials such as thermoplastic elastomers or TPEs demonstrate the performance, safety and durability needed for medical devices to ensure compliance to protocols and delivery of medical care. TPEs, thus, provide the raw material specifications of manufacturers of medical equipment and accessories.

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 series compounds for medical device applications including for direct contact with blood and body fluid management products.

Drawing the material benefits of TPE

The THERMOLAST® M series offers the advantages of resealing, low surface friction and high elasticity; and has a hardness range from 60VLRH (Super Soft) to 50Sh D (Semi Rigid) that are suited for applications for blood collector cap sealing; infusion caps, which are widely used in sealing for pump dosage systems; injection fuel plugs, seal head of syringes, urinary catheter caps, menstrual cups, and hoses.

Evidence of Safety

The THERMOLAST®M compounds are free of animal-based ingredients; and free of latex, PVC, and phthalates. The compounds are produced without the use of heavy metals; and are sterilizable under autoclave 134°C, gamma radiation 2x35 kGy, and EtO-gas.

Furthermore, 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; DIN ISO 10993-11 Acute system toxicity; and 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.