KRAIBURG TPE has announced that its thermoplastic M compound meets the requirements of the 2017 guidelines for medical grade plastics (MGP), approved by the German Institute of Engineers (VDI) in July 2019.
As a reference guide for plastics manufacturers and users, the VDI 2017 Code states that from basic requirements to formulation consistency and revision management and recall clauses, every qualified MGP must meet these requirements.
Twenty material suppliers, users, and notified bodies have formed a Code Committee (RA) to develop minimum common standards for medical-grade plastics (MGP).
Previously, despite the Food and Drug Administration (FDA) 's Drug Master File (DMF) and ISO 10993 for biocompatibility of medical products, including implants, in vitro diagnostics, and drug packaging materials Standards, as well as EU regulation MPV 2017/745 on medical products that will take effect from May 2020, the EU and the US have not previously had clear guidelines or standards for polymers in this important area.
"VDI 2017 is a very important first step in unifying the range of performance that medical grade plastics must meet. It provides mandatory communication between medical grade plastics manufacturers and OEMs and / or medical, pharmaceutical and in vitro product manufacturers. Guidelines, "said Oliver Kluge, a member of the Guidelines Committee and KRAIBURG TPE Medical Product Advisor. "The new guidelines clearly define the range of options available to individual material suppliers and their customers to facilitate their wider arrangements."
One of the main impacts of VDI 2017 was to limit the range of raw materials and additives allowed for medical grade plastics, which meant that some manufacturers had to adjust their material formulations.
The new guidelines also provide for the use of a record change control management system to control the continued controllability of specific compound components, ensuring that compounds are suitable for long-term use without the need for costly inspections. VDI 2017 also allows a longer transition period for recalled materials, ensuring more supply security for users.
"Our Thermoplastic M Series medical grade thermoplastic elastomers have long met the guidelines for medical grade plastics, so we only need to provide more detailed specifications," Kluge said. "But we will continue to actively monitor future revisions of the guidelines to further improve the safety of medical-grade plastics."
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 2020. At the VDI Conference on Medical-Grade Plastics in Berlin in early July 2019, the set of rules had been proposed and fully discussed.
A wide range of certified medical grade thermoplastic elastomers
All Thermoplastic M-series compounds are free of heavy metals, latex, PVC and phthalates, and are all produced on a dedicated production line with the highest purity.
Various materials have been carefully selected 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 certified. Quality assurance of raw materials also includes full traceability of the lot on the supplier side. KRAIBURG TPE is also REACH and RoHS compliant.
In addition, the Thermoplastic M product series is also included in the FDA's Drug Master File (DMF), and recipe changes are recorded according to the change control process.
In order to further ensure compliance with the new VDI 2017 guidelines, KRAIBURG TPE also covers the manufacturing process in the change control management system, and the original formulation of such compounds will be retained with the new formulation for at least 24 months after the notification of the change or recall . This provides the highest standards of quality control and supply security for thermoplastic elastomer medical compounds used by customers in the healthcare, pharmaceutical, medical, and diagnostic industries.
The complete product range covers compounds of different hardnesses, all of which can be easily sterilized using conventional methods such as ethylene oxide (EtO), steam, gamma rays or electron rays.
In addition to standard compounds that optimize grip and non-slip properties, we also offer product types with excellent adhesion to technical thermoplastics such as polyester and polyamide.
Thermoplastic M Series compounds also provide translucent and high transparency products that are important for visual inspection in medical applications, as well as oil-free compounds and specific compounds in sealing applications.