Chemicals specialists Clariant have announced that the recently expanded medical compounding facility in Lewiston, Maine, US – alongside two other sites in Sweden and Singapore – have been certified to stringent quality standards.
Clariant
Lewiston medical compounding site with “all polymer” capability
Lewiston medical compounding site with “all polymer” capability
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, the new quality standard (ISO 13485-2016) goes into full effect at the end of February 2019. Device submissions under the old version will no longer be allowed.
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. Increasingly, they will need to ensure trust by using expertise coming from materials suppliers who have a good understanding of and products adapted to the needs of the healthcare market.”
ISO 13485 applies only to producers of medical devices as it helps reduce risk of changes in raw materials impacting device performance, reliability, or regulatory compliance.
The Maine event
The three global facilities, almost entirely dedicated to medical and pharmaceutical applications, provide assurance of consistency in formulations and procedures, and supply-chain reliability for all MEVOPUR products.
Compliance with the new standard is the final piece of Clariant’s expansion program at the Lewiston facility, which was expanded by 40%. Now accommodating not only extrusion equipment, but materials handling, weighing stations, a maintenance area and additional water-cooling capacity. These enable the Lewiston plant to more rapidly produce larger batch sizes of MEVOPUR pre-colored medical plastic compounds.
A smaller line, installed last year, is configured to meet the rigorous processing requirements of fluoropolymer resins such as, FEP, ETFE, and PVDF.
