KRAIBURG TPE TPE meets new guidelines for medical-grade plastics

KRAIBURG TPE announces that its Thermoplastic M compounds meet the requirements of the 2017 Guidelines for Medical Grade Plastics (MGP) adopted by the Society of German Engineers (VDI) in July 201

As a reference guide for plastics manufacturers and users, the VDI 2017 guidelines set out the requirements, from basic requirements to formulation consistency as well as amendment management and recall provisions, that every qualified MGP must me.

Twenty material suppliers, users and notified bodies have formed a Guidelines Committee (RA) to develop minimum general standards for medical grade plastics (MG.

Previously, despite the Drug Master File (DMF) issued by the.

"VDI 2017 is a very important first step towards unifying the range of properties that medical grade plastics must meet, it provides mandatory communication between medical grade plastic manufacturers and OEMs and/or medical, pharmaceutical and in vitro product manufacturers Guidelines,” said Oliver Kluge, Member of the Guidelines Committee and Consultant for KRAIBURG TPE® Medical Produc.

One of the main impacts of VDI 2017 was to limit the range of raw materials and additives allowed in medical-grade plastics, which meant that some manufacturers had to adjust their material formulatio.

The new guidelines also provide for the use of a record change control management system to maintain ongoing control over the composition of a specific compound, ensuring that the compound is suitable for long-term use without the need for multiple expensive inspectio.

"Our THERMOLAST® M-Series medical-grade thermoplastic elastomers have long met the guidelines applicable to medical-grade plastics, so we just need to provide more detailed specification information," Kluge sa.

In the context of the EU regulation MPV 2017/745 mentioned above, the VDI 2017 Medical Grade Plastics Guidelines Committee plans to revise this version as early as 202 At the beginning of July 2019, at the VDI Congress on Medical-Grade Plastics in Berlin, this set of rules was proposed and fully discuss.

Wide range of certified medical-grade thermoplastic elastomers

All THERMOLAST® M-Series compounds are free of heavy metals, latex, PVC and phthalates and are produced at the highest purity on dedicated production lin.

A variety of carefully selected materials have been tested according to USP Class VI (chapter 88), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intradermal irritation), ISO 10993-11 (acute systemic toxicity) and ISO 10993-4 (blood compatibility) tested and certifi.

In addition, THERMOLAST® M product line is listed on the FDA's Drug Master File (DMF), and changes to formulations are documented in accordance with a change control proce.

To further ensure compliance with the new VDI 2017 guidelines, KRAIBURG TPE has also included the manufacturing process in the change control management system and the original formulations of these compounds will be retained alongside the new formulations for at least 24 months after notification of a change or reca.

The complete product range covers compounds of varying hardness, all of which can be easily sterilized using conventional methods such as ethylene oxide (EtO), steam, gamma rays or electron bea.

In addition to standard compounds optimized for grip and slip resistance, product types with excellent adhesion to technical thermoplastics such as polyester and polyamide are also availab.

        THERMOLAST® M-Series compounds are also available in translucent and high transparency products for visual inspection, which are important in medical applications, as well as oil-free and specific compounds in sealing applicatio.