CLINTON, Tenn.– Techmer PM LLC has plenty to showcase at the MD&M West trade show in Anaheim, Calif., April 12-14. Occupying booth #2362, the Clinton-based compounder and materials design firm will unveil its new “HC” brand for medical devices and healthcare applications.
“These materials leverage our proven technologies in both engineered compounds and masterbatch,” notes Steve Loney, the firm’s market development director. “For example, if a customer needs our Plaslube® internally lubricated engineering thermoplastic technology but with the stringent medical compliance certifications, they now can purchase our Plaslube® HC.” The expanded HC portfolio relies upon a full palette of ISO 10993- and USP Class VI-compliant pigments and additives to accelerate the development of customized healthcare products.
Additionally, Techmer PM on March 17 completed a Stage 2 audit for ISO 13485 certification at its Batavia, Ill., site, which is already ISO 9001 certified. This is the final step in confirming that its quality management system at the plant conforms to all the requirements for safe medical device manufacturing.
“We are thrilled to gain this recognition in Batavia and all credit to the team there,” said Technology Vice President Dr. Bhushan Deshpande. “With this certification, our customers will enjoy the benefits of products manufactured under the highest level of regulatory and safety compliance for medical device applications.”
Techmer PM also is continuing its work developing a safe, readily available alternative to the PFOA and PFAS chemicals used to make medical pipettes that are increasingly the subject of health-related bans and restrictions in the United States, the European Union, and elsewhere.
Perfluorooctanoic acid (PFOA) and polyfluoroalkyl substances (PFAS) traditionally have been incorporated in the polymer compounds for this application since they are hydrophobic and help to fully evacuate the contents of such plastic pipettes. But now, in addition to the growing regulatory actions, there is a severe market shortage since these concerns prompted a major PFAS plant in Europe to shut down late last year by emergency order.
In response to market needs, Techmer PM has developed a low-retention technology for pipettes and labware that delivers equivalent or better performance to traditional technologies and meets the stringent new EU and U.S. PFOA limits, notes Deshpande. “Several customers are currently testing this new formulation, which has been shown in internal studies to meet all the requirements, including being sterilizable and translucent while offering full evacuation of contents.”
Techmer PM –– which can provide these fully compliant materials in masterbatch or compound form –– remains keen to engage with interested development partners for further work in fluorine-free products.
Techmer PM invites you to connect with its officials at Booth #2362 at the upcoming MD&M West show.
