Medical product manufacturers who seek the high-performance properties of PEEK (polyetheretherketone) polymers for medical devices can now get them in a wide range of colors for injection molding or precision profile extrusions.
Clariant Masterbatches has developed fully customized compounds and a range of color masterbatches formulated specifically for PEEK resins, which are recommended for use in disposable and multiple-use and re-sterilizable devices (Class 1 and 2). The fully compounded grades are available in large and small quantities and can incorporate radiopaque, anti-microbial or antistatic fillers as well as other performance enhancing features. Clariant Masterbatches featured these new materials at the recently concluded MD&M-East show New York City.
“PEEK high-performance polymers offer high mechanical strength combined with excellent stress crack resistance. They can withstand the high-temperature conditions and chemical exposure encountered during medical device sterilization, and they are dimensionally stable and electrically resistant,” says George Pape, Medical Device and Healthcare Market Manager, Clariant Masterbatches. “In their natural form, many PEEK grades inherently have a light brown tone, which makes color matching challenging. In addition, they are normally processed at over 700°F so any pigments, fillers or stabilizers need to be very heat stable. We take these issues and the ultimate applications into account when developing new PEEK compounds.”
Fully compounded products are frequently the best choice for producers of precision extrusions, and micro and two-shot moldings that require high levels of radiopaque fillers and pigments or when smaller extruders are used. Compounds deliver the best product consistency and yields, and come with assurances of formulation accuracy that are so important to medical manufacturers.
Clariant Masterbatches’ medical compounding operations have the engineering and technical resources, stringent quality-assurance programs, advanced manufacturing capabilities and the ability to respond quickly. Whether standard or custom formulations are required, Clariant’s flexibility allows processors to begin product development and pre-production phases of a project quickly and effectively. To help support the stringent demands of medical device manufacturers, who are regulated by the US FDA and other global regulatory bodies, RENOL® MD masterbatches and RENOL MC compounds are produced under strictly controlled manufacturing conditions. The pigments, additives and polymers used in these products have been tested and shown to be compliant with USP Class VI biocompatibility test protocols. Clariant provides customers reassurance of fixed formulations of high quality and purity, combined with pre-tested raw materials. The Company is actively pursuing updated biocompatibility compliance with a broad range of raw materials under ISO 10993. To facilitate and expedite the approval process for any new medical device application, Clariant maintains an FDA Drug Masterfile (DMF), to provide needed information directly to FDA reviewers. The PEEK medical products are part of Clariant’s RENOL series of color masterbatches and compounds, developed to meet the stringent requirements of high-performance applications, not only in the medical market but also in aerospace, automotive, electrical devices, and military.
Clariant Masterbatches products are marketed under the following global brand names: REMAFIN® olefinic masterbatches and compounds; RENOL® masterbatches and compounds based on engineering resins, styrenics and PVC; CESA® additive masterbatches; HYDROCEROL® chemical foaming and nucleating agents; OMNICOLOR® universal color masterbatches. These brand names are all registered trademarks of Clariant.
Clariant – Exactly your chemistry
Clariant is a global leader in the field of specialty chemicals. Strong business relationships, commitment to outstanding service and wide-ranging application know-how make Clariant a preferred partner for its customers. Clariant, which is represented on five continents with over 100 group companies, employs about 20,000 people. Headquartered in Muttenz near Basel, Switzerland, it generated sales of CHF 8.1 billion in 2008. Clariant’s businesses are organized in four divisions: Textile, Leather & Paper Chemicals; Pigments & Additives; Functional Chemicals; and Masterbatches. Clariant is committed to sustainable growth springing from its own innovative strength. Clariant’s innovative products play a key role in its customers’ manufacturing and treatment processes or else add value to their end products. The Company’s success is based on the know-how of its people and their ability to identify new customer needs at an early stage and to work together with customers to develop innovative, efficient solutions.