KRAIBURG TPE, Germany-based producer of TPE materials for various markets, 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. The production of the new THERMOLAST® M compounds will be carried out exclusively at company's headquarters in the Bavarian town of Waldkraiburg emphasizing safety and reliability. A dedicated production line there processes only raw materials that have been approved for medical use guaranteeing safety and reliability. As opposed to elastomers or silicone compounds, they can be used in a 2-component injection molding process, saving time and money.
The company says THERMOLAST® M compounds are certified as per all the usual medical technology standards including DIN ISO 10993/5/10/11 or USP Class VI. Extraction studies conducted by impartial institutions provide further confirmation of TPE quality. Due to extensive testing by pilot projects carried out jointly with clients, the company offers five different series of compounds with superb bonding properties to HDPE, PP, ABS and PC/ABS resins and eliminate any possibility of materials in diaphragms, seals or valves detaching themselves from pharmaceuticals packaging and entering the bloodstream. The compounds are suitable for gamma sterilization and permit autoclaving with superheated steam at temperatures of up to 134°C. 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.