Materials supplier Techmer PM LLC will unveil its new HC brand for medical device and healthcare applications at next month’s co-located Plastec West and Medical Design & Manufacturing (MD&M) West event in Anaheim, CA. Medical device OEMs can choose from a selection of engineered compounds comprising ISO 10993– and USP Class VI–compliant pigments and additives, which can help to accelerate product development.
“These materials leverage our proven technologies in both engineered compounds and masterbatch,” noted Steve Loney, 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.”
Additionally, Techmer PM on March 17 completed a Stage 2 audit for ISO 13485 certification at its Batavia, IL, site, which is already ISO 9001 certified. This is the final step in confirming that the plant’s quality management system conforms to all the requirements for safe medical device manufacturing.
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 around the world.
Plant shutdown causes PFAS shortage
Perfluorooctanoic acid (PFOA) and polyfluoroalkyl substances (PFAS) traditionally have been incorporated in polymer compounds for this application since they are hydrophobic and help to fully evacuate the contents from the 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, said Techmer PM.
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 stringent new EU and US PFOA limits, noted Technology Vice President Dr. Bhushan 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 can provide these fully compliant materials in masterbatch or compound form and said that it remains keen to engage with development partners for further work in fluorine-free products.
Techmer PM will exhibit at booth 2362 at Plastec West and MD&M West on April 12 to 14 at the Anaheim Convention Center in Anaheim, CA. The shows are part of the Informa Markets – Engineering (IME) West event, which also includes WestPack, automation show ATX, and Design & Manufacturing (D&M).