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Keywords of this article:  injection molding 
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KRAIBURG TPE and Eastman will showcase materials with coordinated adhesion for medical hard/soft applications at Pharmapack 2019.
KRAIBURG TPE and Eastman will showcase materials with coordinated adhesion for medical hard/soft applications at Pharmapack 2019.

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 thermoplastic elastomers (TPEs).

In close cooperation with Eastman, KRAIBURG TPE has developed a range of THERMOLAST M 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.

KRAIBURG TPE and Eastman will unveil the new range of adhesion-optimized THERMOLAST M TPEs at Pharmapack 2019 from February 6 to 7, 2019 in Paris.

Suitable for both soft and hard medical applications

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.

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.

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.

Comprehensive tests of THERMOLAST M compounds show excellent peel strength on the various Eastman Tritan copolyester types,” confirmed 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 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,” said Ludovic Gardet, Application Development & Technical Service of Eastman.

Tested and certified compounds

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.

The company 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.

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