Specialist chemical company Clariant has seen its recently expanded facility in Lewiston, Maine, and two other sites in Malmo, Sweden, and Singapore, certified to the 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. Device submissions under the old version will no longer be allowed.
Deepak Parikh, president, North America region, 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 – high value products with unique technologies.”
Although ISO 13485 technically only applies to producers of medical devices, it is seen as an important standard for their suppliers because it helps reduce risks such as risk of changes in raw materials impacting device performance, reliability, or regulatory compliance.
Steve Duckworth, head of the Global Medical and Pharmaceutical Segment for Clariant Plastics & 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. Increasingly, they will need to ensure trust by using expertise coming from materials suppliers – like Clariant -- who have a good understanding of and products adapted to the needs of the healthcare market.
