Kraiburg TPE (Waldkraiburg, Germany) announced today that its Thermolast M compounds meet the requirements of the 2017 VDI guidelines for medical-grade plastics passed by the Association of German Engineers (VDI) in July 2019. The guidelines regulate the basic requirements of medical-grade plastics, including formulation consistency, change management and the conditions and terms of withdrawing the material from the market.
The VDI guidelines are the result of work conducted by a committee of 20 materials suppliers, users and appointed bodies to establish a common minimum standard for medical-grade plastics. Existing norms and standards, such as the Drug Master Files issued by FDA and ISO 10993 related to biocompatibility, as well as the EU Regulation MPV 2017/745 on medical products that comes into effect in May 2020, do not establish clear guidelines involving polymers used in medical applications, said a press release from Kraiburg TPE.
“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 medical-grade plastics 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, according to Kraiburg TPE, is a restriction on the use of certain raw materials and auxiliary agents. Consequently, some manufacturers of medical-grade plastics will have to adjust the formulations of their materials in order to meet the requirements of the guidelines.
The new guidelines also regulate the continuity of the composition of specific compounds based on a documented change control management system, which ensures that the compounds are suitable for long-term use and eliminates costly checks. The VDI 2017 guidelines also allow for longer transition periods for withdrawn materials—the original material must remain available for a minimum of 24 months in the event of a change in formulation or its withdrawal.
“Our established thermoplastic elastomers from the Thermolast M family for medical use have [complied] for a long time with the requirements for medical-grade plastics, which are now codified, so that we only need to flesh out some of the specifications,” Kluge explained in a prepared statement. “But we will continue to actively work on future revisions of the guidelines to further enhance the secured profile of medical-grade plastics.” In the context of the aforementioned MPV 2017/745, the committee is planning to revise the current version as early as 2020.
All Thermolast M compounds are free from heavy metals, latex, PVC and phthalates and are manufactured exclusively on dedicated production lines, noted Kraiburg TPE in the press release. Select material types have been tested and certified according to various USP Class VI and ISO standards, and all Kraiburg TPE materials comply with REACH and RoHS requirements.