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Lewiston medical compounding site with “all polymer” capability.
Lewiston medical compounding site with “all polymer” capability.

Clariant’s recently expanded facility in Lewiston Maine, and two other sites in Malmo, Sweden, and Singapore, have been certified to the stringent new quality standard for makers of plastic medical devices. The plants produce specialized polymer compounds and masterbatches offered for medical applications under the MEVOPUR brand.

After a 3-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.

Although ISO 13485 technically only applies to producers of medical devices, it is seen as an important standard for their suppliers, like Clariant, because it helps reduce risks such as risk of changes in raw materials impacting device performance, reliability, or regulatory compliance.

Increased use of QbD (Quality by Design) processes means that more consideration needs to be given to materials used and impact on patient safety.

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. Raw materials are pre-tested to standards commonly required for device and drug filings.

The desire to comply with the requirements of the new ISO 13485-2016 standard presented additional challenges, said the company. For example, for the first time, computerized systems needed to be risk-assessed, and then the appropriate validation or verification activities carried out. Even if software is not directly controlling processes, it often present in test equipment used to control raw materials or end-product quality.

The project to implement the new version ISO13485-2016 was conducted on a global basis with local site quality managers supported by Clariant’s dedicated Global Quality & Regulatory manager for the healthcare sector.

Compliance with the new ISO 13485-2016 standard, caps off a multi-million dollar, multi-year expansion program at the Lewiston, Maine. The facility, which was expanded by 40%, now accommodates not only extrusion equipment, but also materials handling, weighing stations, a maintenance area and additional water-cooling capacity that 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.

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