PolyOne supports OEMs, processors, and converters with a full line of colorants and additives specially designed for healthcare environments. By working to understand your unique requirements, we provide the resources to help effectively meet the demands of your customers and applications.

Enhance your brand with our full range of color solutions from liquid color to pearlescent, metallic, and fluorescent special effects. Gamma-stable, USP Class VI and ISO 10993 grades are available.

HIGHLIGHTS

Materials have been developed specifically to meet or exceed USP Class VI & ISO 10993.

Manage risk with our FDA cGMP program together with our No Surprises Pledge℠. Accelerate your speed to market with our custom color development turnaround time that sets the standard for the industry and helps you efficiently design your products. Navigate regulatory requirements with the support of our global regulatory and product stewardship expertise.

Supporting Your Qualification Needs

PolyOne understands your unique challenges. Our support and service solutions help you meet your regulatory and performance requirements, including:

• Medical-grade raw materials formulated without heavy metals, phthalates, and BPA
• Healthcare application screening process and formula review to help customers meet desired end-use requirements
• World-class FDA cGMP manufacturing facilities open to your audit requirements
• State-of-the-art batch traceability systems and formulation lockdown
• Maintenance of FDA Drug Master Files (DMFs) or Medical Device Files (MDFs) upon request
• Global expertise - global color labs and design centers with healthcare application expertise