出版物: 2022 年 3 月 14 日 最近更新時間: 2025 年 3 月 12 日

凯柏胶宝®专为亚太地区开发全新医疗再密封化合物


  • 现推出其最新的 HC/RS/AP 再密封系列,归于 TPE 化合物中的热塑宝 H 系列,适用于医疗保健和医疗再密封领域。

作为一家全球知名的 TPE 制造商,凯柏胶宝®致力于为各行各业提供类型多样的优质热塑性弹性体产品和定制解决方案,现推出其最新的 HC/RS/AP 再密封系列,归于 TPE 化合物中的热塑宝 H 系列,适用于医疗保健和医疗再密封领域。

密封件可显著影响医疗器械的功能,器械所输送物质的状况,并会影响该器械应用的治疗是否能取得成功。医疗、制药、生物技术及其他生命科学领域中应用的密封件用于防止污染、泄漏和溢出。因此,其应表现出良好的机械性能、化学耐受性、生物相容性以及其他性能。

寻找合适的材料来满足创新设计的要求,特别是对于医疗器械组件,如再密封系统,这对于优化功能和性能至关重要。

与传统的医用橡胶或塑料相比,热塑性弹性体 (TPE) 具有许多材料优势,在医疗保健行业越来越受欢迎。

作为热塑性弹性体化合物的全球竞争力领导者,凯柏胶宝®提供高质量、定制化的 TPE 化合物,以应对医疗设备设计方面所带来的挑战,如密封应用。

“我们在马来西亚史里肯邦安的工厂生产热塑宝 H 化合物,从而可以在短交付周期内为亚洲客户提供高质量的产品。我们还提供特定应用和技术相关支持,以及产品定制服务,满足客户需求,是客户可信赖的供应商”,热塑宝 H Asia Pacific Market Launch Project Manager, Aditya Purandare 评论道。

经批准的再密封材料解决方案 
凯柏胶宝®的热塑宝H HC/RS/AP 化合物系列对 PP 和 PE 有良好的包胶性,使其成为医疗和保健再密封应用的理想选择,如瓶盖、封口、隔膜和塞子。 
此外,该系列具有低密度,可在 121℃ 和 EtO 下进行高压灭菌,因此非常适合用于制作样品和试管的重密封瓶盖、医用小瓶盖,以及一次性胰岛素注射器包装膜。
该化合物有半透明和各种颜色可选,能够满足灵活创新设计。


该化合物使用安全,符合 ISO10993-5 和 GB/T 16886.5(细胞毒性)标准,以及多个全球性食品接触与医疗标准,包括中国国标 GB 4806 – 2016、美国 FDA CFR 21、欧盟法规 (EU) No.10/2011、REACH,以及 RoHS,并已按照 DIN ISO 15759 测试再密封性能。

 “客户可以对热塑宝H 产品的价值充分放心。我们有信心可以为客户提供符合亚太地区医疗标准的材料解决方案,所有这一切都归功于我们对 TPE 产品的市场支持和专业知识”,Lee Jia Yin,凯柏胶宝® Product Specialist如是说。
 

凯柏胶宝®医疗与保健 TPE 即将开展的的活动

KRAIBURG TPE develops next generation medical resealing compound for Asia Pacific only


Introducing HC/RS/AP resealing series, under the THERMOLAST® H range of TPE compounds for healthcare and medical resealing applications.

KRAIBURG TPE, a global manufacturer of a diverse range of thermoplastic elastomer products and custom solutions for a variety of industries, is introducing its latest HC/RS/AP resealing series, under the THERMOLAST® H range of TPE compounds for healthcare and medical resealing applications.

Seals have a significant impact on the functionality of medical devices, as well as the condition of the substance delivered by the device, and the success of the treatment for which it is employed. Seals for medical, pharmaceutical, biotechnology and other life sciences applications are used to prevent contamination, leakages, and spillages. They must also exhibit good mechanical performance, chemical resistance, biocompatibility, and other capabilities.

Finding the right material to fit the requirements of innovative designs, especially for medical device components such as resealing systems, is vital for optimizing functionality and performance.

Hence, thermoplastic elastomers (TPEs), which offer many material advantages over traditional medical rubbers or plastics, are becoming increasingly popular in the medical and healthcare sectors.

As the global competence leader in thermoplastic elastomer compounds, KRAIBURG TPE offers high-quality, custom-engineered TPE compounds that match the challenges of medical device designs, such as sealing applications.

"By manufacturing the THERMOLAST® H compounds in Malaysia, at our facility in Seri Kembangan, we will be able to provide our Asian customers a high-quality product with quick lead times. Coupled with application and technical support, and product customization, customers will be able to rely on us for their needs," commented Aditya Purandare, Project Manager of the Market Launch of THERMOLAST® H Asia Pacific.

Material solutions with seal of approval

KRAIBURG TPE’s THERMOLAST® H HC/RS/AP family of compounds boasts good adhesion to PP and PE, making it ideal for medical and healthcare resealing applications such caps, closures, membranes, and plugs.

Furthermore, the series has a low density and can be sterilized by autoclave at 121°C and EtO, making it ideal for use on resealing caps for sample and test tubes, medical vial closures, as well as the membranes in disposable insulin syringes.

Available in translucent color and various color options, the compounds are able to cater to the flexibility of innovative designs.

The compounds are safe for use, complying with ISO10993-5 and GB/T 16886.5 (cytotoxicity) standards, as well as many worldwide food contact and medical standards, including China GB 4806 – 2016, US FDA CFR 21, Regulation (EU) No 10/2011, REACH, and RoHS, and resealing performance is tested according to the DIN ISO 15759.

“Customers are assured of the THERMOLAST® H product value. We are confident of delivering material solutions that meet the medical standards in Asia Pacific, all thanks to our dedicated market support and expert knowledge in TPE products,” says Lee Jia Yin, Product Specialist, KRAIBURG TPE.

凯柏胶宝® - 快览
 

  • 总部和生产基地:瓦尔德克赖堡/德国
  • 区域总部和生产基地:吉隆坡/马来西亚,亚特兰大/美国
  • 产品:热塑性弹性体化合物
  • 品牌:热塑宝、科柔宝®、高温宝和尼塑宝®
  • 市场:欧洲、美洲、亚太地区
  • 员工:660

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