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KRAIBURG TPE’s thermoplastic elastomers in the THERMOLAST M family meet the new VDI 2017 guideline.
KRAIBURG TPE’s thermoplastic elastomers in the THERMOLAST M family meet the new VDI 2017 guideline.

KRAIBURG TPE announced that its THERMOLAST M compounds meet the requirements of the 2017 guideline for medical grade plastics (MGPs) passed by the Association of German Engineers (VDI) in July 2019.

Intended as a guideline for manufacturers and users of plastics for medical products, the VDI 2017 guideline regulates the requirements qualified MGPs have to meet, from basic requirements to formulation consistency and modification management through to withdrawal terms.

Twenty materials suppliers, users and appointed bodies had formed a guidelines committee (RA) to work on a common minimum standard for MGPs, as there had previously been no clear guidelines or standards in the EU and the USA relating to the polymers used in this vital field of application - despite the Drug Master Files (DMF) issued by the Food and Drug Administration (FDA) in the USA and the ISO 10993 standard for the biocompatibility certification of medical products (including implants, in vitro diagnostic agents and pharmaceutical packaging), as well as the EU Regulation MPV 2017/745 on medical products that will become binding from May 2020.

“The VDI 2017 is an important first step toward harmonizing the range of performance that a medical grade plastic must fulfill, and it creates obligatory guidance in the communication between manufacturers of MGPs and OEMs and/or the manufacturers of medical, pharmaceutical and in vitro products,” said Oliver Kluge, a member of the guidelines committee and advisor for medical products at KRAIBURG TPE.

One of the main consequences of VDI 2017 is a restriction of 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 regulates the controlled continuity of the composition of specific compounds based on a documented change control management system, which ensures that the compounds are suitable for use for a long-term period and makes costly checks unnecessary. The VDI 2017 also allows for longer transition periods for withdrawn materials, thus providing more supply security to users.

Against the background of the MPV 2017/745 mentioned above, the VDI 2017 Medical Grade Plastics guidelines committee is planning to revise the current version for the first time as early as in 2020. The set of rules was presented and discussed in great detail at the VDI conference on MGPs held in Berlin in early July 2019.

Broad range of certified medical grade TPEs

All THERMOLAST M compounds are free from heavy metals, latex, PVC and phthalates and are manufactured exclusively on dedicated production lines and at the highest degree of purity. A number of select material types have been 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 also covers full traceability of batches on the suppliers’ side. KRAIBURG TPE’s materials also comply with REACH and RoHS requirements.

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