THERMOLAST® H comes in 2 series which is HC/AP and HC/RS AP designed exclusively for the healthcare and medical device applications in Asia Pacific. The new TPE series comply with Cytotoxicity GB/T 16886.5, ISO 10993-5, various global food contact and relevant medical standards. The series featured properties such as adhesion to PP, haptics, compression set, resealing low density and soft-touch quality, suitable for applications like mouthpieces, medical devise, closures, caps, etc.
The THERMOLAST® M series is available in translucent, transparent, and natural colors, with high transparency and precoloring options. The compounds are compliant with VDI 2017 and ISO 10993-5 and listed in the Drug Master File. The selective TPE series has good resealing, compression set, low friction and elasticity. KRAIBURG TPE's Medical Service Package guarantees optimum raw material purity, solid 24-month supply security and assures optimum safety with excellent control management.
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.