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Clariant Increases Capacity for Mevopur Medical Products

| Editor: Alexander Stark

Clariant's ISO 13485 plant in Maine
Clariant's ISO 13485 plant in Maine (Source: Clariant)

Clariant has commenced operation of a high throughput twin-screw compounding extruder at its facility in Lewiston. 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.

Mutten/Switzerland — The expansions enable the Lewiston plant to more rapidly produce larger batch sizes of Mevopur pre-colored medical plastic compounds (e.g.: 3,000 to 6,000kg /6000 to 12,000lbs or larger), the company announced. A smaller line, installed last year, is configured to meet the processing requirements of fluoropolymer resins such as, FEP, ETFE, and PVDF.

The Lewiston plant is one of three global sites designed and operated to produce materials used in medical devices and pharmaceutical packaging. The other two facilities are located in Malmö, Sweden, and Singapore. All are certified to EN:ISO13485 and can use the same validated raw-material ingredients and processes so that the same products can be produced at any of the sites. Raw materials are pre-tested to standards commonly required for device and drug filings, e.g.: USP <88> ('USP Class VI') and ISO10993, and, in a newly announced development, to the USP <661.1>, ICHQ3D and European Pharmacopeia monographs 3.1 covering drug packaging and delivery devices.

Fluoropolymers are being used in medical catheters and other applications such as diagnostics that can benefit from their flexibility, lubricity and chemical resistance.

The company will continue to operate several smaller lines — in Lewiston and other Mevopur facilities — which produce masterbatches and pre-colored compounds in lot sizes ranging from 25 to 2,500kg/50 to 5,000 lbs.

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