Clariant International Ltd. is renovating a Lewiston, Maine, masterbatch plant for dedicated medical and pharmaceutical production of color concentrates and customized compounds.
Clariant made the decision to modify the facility in November and, while maintaining operations, is working through the pre-bottleneck and debottlenecking stages, said George Pape, Clariant masterbatches medical-device and health-care market manager for North America.
Each compounding machine making the Mevopur-brand materials will operate in a segregated environment to minimize the potential for cross-line contamination or dust infiltration, Pape said.
We've already established stringent incoming raw-materials evaluation and segregated the warehouse of medical raw materials, he noted.
Previously, the Lewiston site produced materials mostly for bottle caps and industrial applications with a small volume for the medical market. The non-medical work is being transferred to other Clariant facilities with similar capabilities.
The Clariant masterbatches business unit recognized that you can't run an industrial plant and then run medical at a facility of Lewiston's size, Pape said in a Feb. 8 interview during the UBM Canon trade shows in Anaheim.
The Lewiston plant occupies 35,000 square feet and has 25-28 fulltime employees.
Larger Clariant masterbatch centers in Singapore and MalmÃ¶, Sweden, had space available for totally segregating the machinery and raw materials for medical applications while handling other production, Pape noted.
Each of the three Clariant facilities for medical and pharmaceutical production is certified under ISO 13485, and the Lewiston renovation will make small adjustments as needed to maintain that status.
Our Mevopur-brand products are produced from a common base of biocompatibility-tested pigments at each of the three sites, making availability and [U.S. Food and Drug Administration] approvals faster and less complicated, he said.
Pape said medical and pharmaceutical markets account globally for about 5-6 percent of Clariant masterbatch business, but it is growing at a better pace than the current, larger volumes for the consumer goods, industrial, construction and automotive markets.
Makers of medical devices and packaging using newer resins such as Tritan copolyester from Eastman Chemical Co. or Topas cyclic olefin copolymer from Topas Advanced Polymers GmbH now have access to pretested standards-compliant Clariant Mevopur color options. The Tritan and Topas materials can take the place of polycarbonate for users with health-related concerns about bisphenol-A content in PC.
In late 2010, Clariant established a global medical and pharmaceutical segment within the masterbatches business unit. Masterbatch operations constitute one of 10 business units for Muttenz, Switzerland-based Clariant.