KRAIBURG TPE banking on the medical technology sector

KRAIBURG TPE (www.kraiburg-tpe.com) is expanding its portfolio to include a new product group – "THERMOLAST® M" – directed toward customers in the field of medical technology. Five different series of compounds offer innovative solutions in TPE for use in the pharmaceutical and medical technology markets, covering product reliability risk up to indirect blood contact. Additionally, this TPE specialist with worldwide presence will be offering a comprehensive service and safety package as well as a two-year delivery guarantee. Production is at the company’s headquarters in the Bavarian town of Waldkraiburg. A dedicated production line there processes only raw materials that have been approved for medical use. That guarantees maximum safety and reliability. A separate development and distribution team lays the best basis for satisfying individual market demands. Over and above that, TPE lets manufacturers capitalize on the cost advantages offered by the two-component injection molding process. "We foresee great potential for TPE in medical technology", CEO Franz Hinterecker explains. "THERMOLAST® M puts us in the perfect position to establish ourselves as a reliable partner to our customers over the long term."

New THERMOLAST® M product group
Responding to rising demand, the company has redoubled its development efforts – building on experience already accumulated with two product lines specifically for the medical technology sector. The result: The new THERMOLAST® M product group. It enables processing covering product reliability risk up to indirect blood contact. Dr. Frieder Vielsack, project manager at KRAIBURG TPE, elucidates: "We researched the market and conducted many discussions both with customers and with physicians and health care staff. They reported first-hand on their own experiences." The primary concern was safety. Here KRAIBURG TPE offers its customers a unique service package. The compounds’ suitability is certified as per all the usual medical technology standards, such as DIN ISO 10993/5/10/11 or USP Class VI. Extraction studies conducted by impartial institutions provide further confirmation of TPE quality. "That was one of our customers’ primary demands, since the use of certified materials facilities medical certification for their products," Dr. Vielsack adds.

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Thanks to extensive tests and further refinement, in some cases by way of pilot projects carried out jointly with clients, the company today offers five different series of compounds. TPE’s superb bonding properties – to HDPE, PP, ABS and PC/ABS resins – eliminate any possibility of materials in diaphragms, seals or valves detaching themselves from pharmaceuticals packaging and entering the bloodstream. What’s more, the compounds are suitable for gamma sterilization and permit autoclaving with superheated steam at temperatures of up to 134°C. As opposed to elastomers or silicone compounds, they can be used in a two-component injection molding process, saving time and money. Moreover, being a purely physical blend, manufacturing TPE is significantly cleaner than producing rubber or silicone with the chemical reactions involved. There are no break-down products or crosslinking systems that could enter the medical medium.

The new Medical Technology Division
A further advantage for customers: The delivery guarantee. To facilitate the manufacturers’ efforts in the time and cost-intensive introduction of medical technology products, KRAIBURG TPE pledges to deliver the TPEs in exactly the same form for two years. Should a change nonetheless become necessary, due to a feedstock material no longer being available, for instance, then the customer will also be informed of this at least two years in advance. To ensure this, KRAIBURG TPE has concluded appropriate agreements with its materials suppliers.

Safety is also "write large" in the production of THERMOLAST® M. The company is setting up a separate production unit in Waldkraiburg, dedicating certain pre-existing items of machinery to medical production (Photo). This section will process only input materials that are suitable for medical use. The purpose is to eliminate any possibility of contamination with other products or raw materials from the very outset. This also guarantees optimal purity and consistency. Over and above that, internal guidelines and training seminars for the firm’s own distribution and development team will ensure continuous know-how transfer and uniform standards all around the world. This new division – augmenting the automotive, consumer products and industrial products operations – is ultimately to become the fourth pillar at KRAIBURG TPE.

KRAIBURG TPE GmbH & Co. KG, Waldkraiburg, Germany

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