Specialty chemical company Clariant is focusing on the latest additions to its compounding capabilities for high-temperature, medical fluoropolymers in Booth 620 at the BIOMEDevice 2017 conference in Boston, May 3–4, 2017.
Clariant recently completed a significant expansion at its plant in Lewiston, Maine, adding equipment that increases its capacity to compound high-temperature fluoropolymers, which include FEP, ETFE and PVDF. These materials are important for the production of medical catheters because of their flexibility, lubricity and chemical resistance. Demand for these polymers and for specialized masterbatches, which Clariant markets for medical applications under its Mevopur brand, continue to grow worldwide.
Another expansion at the Lewiston plant, planned for completion in 4Q 2017, will add another compounding line featuring a 70-mm extruder. This line will enable the plant to more rapidly produce larger batch sizes of Mevopur pre-colored medical plastic compounds (e.g.: 3000 to 6000kg /6000 to 12000lbs or larger).
Clariant already operates several smaller lines – in Lewiston and Clariant’s other Mevopur facilities – which produce masterbatches and pre-colored compounds in lot sizes ranging from 25 to 2500 kg/50 to 5000 lbs. In addition, production capacity for compounds is also being added during the first half of 2017 in Singapore, to handle increasing demand of color compounds for local and international customers. These small- and medium-sized lots are in high demand, especially in the medical market, since many resin producers have discontinued or severely curtailed their custom-color offerings in anything smaller than full-truck or railcar quantities.
Clariant’s Mevopur materials are offered for applications in medical devices and pharmaceutical packaging, where strict regulations on materials and change control apply. The Lewiston plant is one of three global sites designed and operated to produce materials used in medical devices and pharmaceutical packaging. The other 2 facilities are located in Malmö, Sweden, and Singapore. All are certified to EN:ISO13485 (2012) 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 <87><88> (‘USP Class VI’) and ISO10993.