Clariant has announced its recently expanded facility in Lewiston, and two other sites in Malmo and Singapore have been certified to the stringent new quality standard for makers of plastic medical devices.
The plants produce specialised polymer compounds and masterbatches offered for medical applications under the Mevopur brand.
After a three year transition period during which manufacturers could continue following an earlier version, ISO 13485-2016 goes into full effect at the end of February 2019, and device submissions under the old version will no longer be allowed.
Deepak Parikh, President for Region North America at Clariant, said: “The completion of this process is a perfect example of Clariant’s strong commitment to creating value for its customers. Demand is increasing for specialised, medical grade compounds and masterbatches.”“Compliance to the new standard and the significant expansion will enable our state-of-the-art Lewiston facility to continue to globally deliver to our customers, to deliver high value products will unique technologies.”
Steve Duckworth, Head of the Global Medical and Pharmaceutical Segment for Clariant Plastics and Coatings, said: “With the introduction of the new standard and increased assessment of risk related to materials and change management, medical device and pharmaceutical companies may need to re-evaluate their reliance on materials and methods of the past.”