Waldkraiburg, Germany – Kraiburg TPE’s Thermolast M compounds meet the requirements of the guideline for medical grade plastics (MGPs) passed by the Association of German Engineers (VDI) in July 2019, the German compounder has announced.
Drawn up by 20 materials suppliers, users and appointed bodies for manufacturers and users of plastics for medical products, the VDI guideline 2017 regulates a wide range of requirements for MGPs, from formulation consistency and change management through to withdrawal terms.
“The VDI 2017 is an important first step toward harmonising the range of performance that a medical grade plastic must fulfil,” said Oliver Kluge, a member of the guidelines committee and advisor for medical products at Kraiburg TPE.
According to Kraiburg TPE, VDI 2017 restricts the range of raw materials and auxiliary agents permitted for MGPs, which means that some manufacturers will have to adjust their materials formulations.
The new guideline also requires continuity in the composition of specific compounds based on a documented change control management system. This ensures that the compounds are suitable for long-term use and makes costly checks unnecessary. The VDI 2017 also allows for longer transition periods for withdrawn materials, thus providing more supply security to users.
“Our established thermoplastic elastomers from the Thermolast M family – for medical use – have for a long time been complying with the requirements for MGPs that are now codified, so that we only need to flesh out some of the specifications,” Kluge explains.
“But we will continue to actively work on future revisions of the guideline in order to further enhance the secured profile of MGPs.”
All Thermolast M compounds are free from heavy metals, latex, PVC and phthalates and are manufactured on dedicated production lines, according to Kraiburg TPE.
The whole product range comprises compounds of different degrees of hardness, which can be sterilised using all common procedures such as ethylene oxide (EtO), hot steam, gamma or electron radiation.
Along with standard compounds for enhanced grip and slip resistance, types providing optimised adhesion to technical thermoplastics such as polyesters and polyamides are available.