Color and Additives
Proven solutions for your critical healthcare applications
The PolyOne Difference
PolyOne delivers color and additive solutions for OEMs, processors and converters focused on healthcare. By working to understand your unique requirements, we provide the resources to help effectively meet the demands of your customers and applications:
Complete Healthcare Solutions
• Materials developed specifically to meet or exceed USP Class VI & ISO 10993
• Manage risk with our FDA cGMP program together with our No Surprises PledgeSM
• Accelerate your speed to market with our custom color match 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
OnColor™ HC Custom Colorants
• 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
OnCap™ HC Performance Additives
• Expand your material options by enhancing functional properties with impact modifiers, UV stabilizers & filters, anti-statics, anti-oxidants, anti-fog, and more
• Optimize operational efficiency throughput with cycle time reducers, multi-purge, foaming agents and more
• Combine your OnColor™ HC Colorants and OnCap™ HC Performance Additives into a single solution
• Customized formulations streamline ordering and processing
• Safe and effective organic and inorganic antimicrobials
• Wide range of resin family compatibility including: PE, PP, PC, PVC, PS, acetal, ABS and more
• Available as a masterbatch or Smartbatch™
Supporting Your Qualification Needs
PolyOne understands your unique challenges. Our OnCallSM 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—15 global color labs and 3 design centers with healthcare application expertise
PolyOne USP Class VI Colors
PolyOne has developed a standard color range for healthcare applications that has been formulated to meet USP Class VI requirements. Standard colors are available for polyolefins, polycarbonate, and ABS systems that require color stability post irradiation (52kGy).
In addition, custom colorants formulated to meet USP Class VI are available for other resins. Custom colorants are tailored to meet or exceed the quality requirements for your unique applications.
All colors are available as masterbatch or pre-color compounds. The colors below represent a sample of the broad range of colors available for healthcare applications.
Our Pledge to You
At PolyOne, we are committed to helping you grow your business with safe and environmentally sound solutions. This commitment is exemplified by our No Surprises PledgeSM, which we make to all customers and markets across the globe.
• You can be confident that, in formulating and manufacturing our materials, we use sustainable practices to provide long-term product viability and sound environmental stewardship.
• You can expect that the materials we produce contain only ingredients that conform to accepted legal and regulatory compliance guidelines.
• You can trust that PolyOne materials meet the rigorous quality and safety management standards required across the globe.
• You can be certain that PolyOne meets or exceeds the material safety data reporting requirements of your country or region.
• When you choose PolyOne, you can be confident our products will help you meet or exceed today’s stringent compliance standards.
|Industry Bulletin Color Additives Healthcare|