Kraiburg TPE (Waldkraiburg, Germany) will introduce high-purity thermoplastic elastomers (TPEs) developed in collaboration with Eastman Chemical Co. (Kingsport, TN) at next month’s Pharmapack show in Paris. The Thermolast range of TPEs are formulated to adhere directly to 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,” said 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.”
Kraiburg TPE’s medical compounds are available in a range of hardnesses. They allow for design flexibility and ease of processing, said the company, and meet all standards for surfaces requiring enhanced grip and slip resistance. They also withstand ethylene oxide, gamma and E-beam sterilization.
“The optimal [combination] 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 Kraiburg TPE,” said Ludovic Gardet, Application Development & Technical Services, Eastman.
Kraiburg TPE and Eastman will present the new range of Thermolast M TPEs at Pharmapack 2019 in Paris on Feb. 6 and 7 at booths F66 and C18, respectively.
Kraiburg TPE ensures compliance of its Thermolast M materials with strict international standards for biocompatibility, purity and quality. All medical compounds are manufactured on dedicated production lines, and are free of heavy metals, latex, PVC and phthalates. 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).
Quality assurance procedures of raw materials used in compounding also cover full traceability of batches from Kraiburg TPE suppliers. In addition, all Thermolast M compounds are listed in FDA Drug Master Files (DMF), documenting their formulation in accordance with a mandatory change control procedure. Availability of the original formulation is guaranteed for at least 24 months after a notification of change comes into effect. This provides controlled quality and supply security to customers in the healthcare, pharmaceutical, medical and diagnostic industries, said Kraiburg TPE.