In line with Kraiburg TPE’s 2019 strategy to increase its focus on medical applications and pharmaceutical packaging, the company recently collaborated with Eastman to develop a range of innovative high-purity TPEs. In close cooperation with Eastman, Kraiburg TPE has developed a range of Thermolast M thermoplastic elastomers (TPEs) with the capability to adhere directly to specialized polymers used in medical applications, including Eastman’s Tritan copolyester, PP, ABS, ABS/PC, and PET.
“Comprehensive tests of Thermolast M compounds show excellent peel strength on the various Eastman Tritan™ copolyester types,” confirms Oliver Kluge, Business Unit Manager Medical Applications at Kraiburg TPE. “We are in the process of expanding our portfolio for the medical and pharmaceutical markets and for this purpose we are focusing on developing new materials for innovative products”.
The medical compounds made by Kraiburg TPE, which are a variety levels of hardness, allow for design flexibility, ease of processing and meet all standards for surfaces requiring enhanced grip and slip resistance. They can also be sterilized using standard treatments with ethylene oxide (EtO), gamma or electron radiation.
“We are pleased with the efficient collaboration with Kraiburg TPE in the field of materials development for medical applications,” says Ludovic Gardet, Application Development & Technical Service of Eastman. “The optimal combining of hard and soft components through injection molding is an excellent way to leverage the benefits of Tritan™ copolyesters’ outstanding attributes, such as clarity, toughness, heat and chemical resistance, and the added functionality brought by the Kraiburg TPE”.
Kraiburg TPE and Eastman will present the new range of Thermolast M TPEs at Pharmapack 2019 in Paris from February 6th to 7th at booths F66 and C18 respectively.
Kraiburg TPE supports its customers and injection molders in the medical and pharmaceutical sectors with a unique service package that ensures the compliance of its Thermolast M materials with strict international standards for biocompatibility, purity and quality. All medical compounds are exclusively manufactured with dedicated production lines. They are free of heavy metals, latex, PVC, and phthalates and offer high purity. A number of select compounds are tested and certified according to USP Class VI (Chapter 88), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritation), ISO 10993-11 (acute systemic toxicity), and ISO 10993-4 (hemolysis).
The quality assurance of raw materials used in compounding also covers full traceability of batches from Kraiburg TPE’s suppliers. In addition, all Thermolast M portfolio compounds are listed in FDA Drug Master Files (DMF) to document their formulation in accordance with a mandatory change control procedure. Kraiburg TPE guarantees the continued availability of the original formulation for at least 24 months after notification before such changes come into effect. This provides maximum controlled quality and supply security to customers in the healthcare, pharmaceutical, medical and diagnostic industries.
Along with its collaboration with manufacturers of hard thermoplastics, Kraiburg TPE has also intensified its market-driven and customer-oriented support for the medical sector. A specialized team of experts is now ready to provide customers with advice on all issues relating to materials selection, development of applications and tools, in addition to approvals according to applicable provisions.
The special Thermolast M compounds are available worldwide and are particularly suitable for use with Eastman Tritan copolyester for medical applications, such as transparent packaging, seals and soft-tip applications.
Kraiburg TPE is a global manufacturer of thermoplastic elastomers. From its beginning in 2001 as subsidiary of the historical Kraiburg Group founded in 1947, Kraiburg TPE has pioneered in TPE compounds, today being the competence leader in this industry. With production sites in Germany, the US, and Malaysia the company offers a broad range of compounds for applications in the automotive, industrial, consumer, and for the strictly regulated medical sectors. The established Thermolast, Copec, Hipex, and For Tec E product lines are processed by injection molding or extrusion and provide numerous processing and product design advantages to manufacturers. Kraiburg TPE features innovative capabilities as well as true global customer orientation, customized product solutions and reliable service. The company is certified to ISO 50001 at its headquarters in Germany and holds ISO 9001 and ISO 14001 certifications at all global sites. In 2017, Kraiburg TPE, with over 620 employees worldwide, generated sales of 178 million euros.