Anaheim, Calif. — Clinton, Tenn.-based engineered plastic compound supplier Techmer PM LLC has launched a new brand of ISO 10993 and USP Class VI compliant pigments and additives for medical devices and health care applications.
"Medical products require a lot of testing and qualifications during their product design and prototyping space," Bhushan Deshpande, vice president of technology at Techmer, told Plastics News at MD&M West in Anaheim. "Between our different locations, we can mimic any customer process, whether it's fiber, film, blow molding, injection molding, you name it. We also have the ability internally to do the testing on most of these."
Amid continued high resin prices and a tight supply chain, decreased availability of raw materials has "caused a lot of issues in terms of qualifications" for the company, Deshpande said.
Over the last year and a half, he said, "something we've learned is when we work with a customer on qualification, we try to get two alternates qualified for each of the raw materials in our formula."
"If [the medical market] has a need for a product, a certain formulation, and they go to the resin manufacturer," it would offer the customer "truckloads" of materials, said Kara Noack, business director of engineered compounds at Techmer PM. "That's often not even in the stratosphere of what [the customer] is looking for.
"They want custom colors … or they want certain kinds of glass fill or other additives," Noack said. "We're like the chefs that bring it all together."
Techmer PM's pigments will also allow medical customers to access more colors than a resin supplier, Deshpande said.
"Resin companies, in some ways, you can have any color as long as it's black," he said.
"These materials leverage our proven technologies in both engineered compounds and masterbatch," Steve Loney, Techmer's market development director, said in an April 4 news release. "For example, if a customer needs our Plaslube [brand] internally lubricated engineering thermoplastic technology but with the stringent medical compliance certifications, they now can purchase our Plaslube HC."
Techmer PM is also developing a safe alternative to the perfluorooctanoic acid and polyfluoroalkyl chemicals used to make medical pipettes.
The chemicals have traditionally been incorporated in polymer compounds because they are hydrophobic "and help to fully evacuate the contents of such plastic pipettes," Techmer said in the release.
Because of increasing health-related bans and regulatory actions in the U.S., the European Union and other places, "there is a severe market shortage," it said.
Techmer PM's low-retention technology for pipettes and labware "delivers equivalent or better performance to traditional technologies and meets the stringent new EU and U.S. PFOA limits," Deshpande said. "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."