Technological breakthroughs in the medical sector have provided more efficient, safer and more affordable systems of healthcare delivery. The rising graying population and changing healthcare needs, to combat newer and stronger viruses, are requiring novel techniques in diagnostics and therapies. These include innovative medical devices for prevention, treatment, and monitoring of health disorders and disabilities.
KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers high-quality custom engineered THERMOLAST® M TPE materials. These are envisioned for medical device applications, including components of medical devices, disposables (e.g., syringes or tubing); as well as for pharmaceutical applications. These compounds are suited for portable medical devices especially used in the homecare setting.
Making safety a criteria
The THERMOLAST® M range is specially developed for applications in the medical, pharmaceutical and diagnostic sectors, such as in devices that are used for direct contact with body fluids and blood.
For the processor and the end customer, the change control management system ensures that fundamental requirements are met.
The THERMOLAST® M series meet the requirements of the VDI guideline 2017 for medical grade plastics (MGPs) issued by the Association of German Engineers (VDI) and the Reach and RoHS standards.
The TPE compounds are free of animal-based ingredients; free of latex, PVC, and phthalates; and they are produced without the use of heavy metals.
Furthermore, the compounds are tested according to DIN ISO 10993-5 Cytotoxicity; DIN ISO 10993-4 Haemolysis, indirect blood contact; DIN ISO 10993-10 Intracutaneous irritation and DIN ISO 10993-11 Acute system toxicity; USP Class VI Extraction.
Easy processing and design features
The THERMOLAST® M range can be processed through extrusion or injection molding; and are sterilizable at autoclave 134 °C, gamma radiation 2x35 kGy and EtO.
Other features of the compounds include the soft touch feel. For example, the MC/TL series offers pleasant soft touch feel that is preferred for applications such medical cap and infusion bag, valves, dental guard, orthodontic appliance, mouth bracelet, bracket, menstrual cup, surgeon pencil grip and lung trainer device.
The MC/RS series has an outstanding resealing property that is essential in applications, including infusion stoppers in blood collector caps, pierced membranes, and more.
Customer satisfaction at the fore
KRAIBURG TPE strives to maintain the standards of its products by providing a unique service package that focuses on our customer needs in constantly recording manufacturing process in the drug master file (DMF); and by guaranteeing 24-month supply security and purity of our raw materials through the commitment of our suppliers and a dedicated production unit for THERMOLAST® M to ensure the quality, safety and reliability of our TPEs.