Regulatory and Compliance Agency Support
PolyOne supports the efforts of a number of regulatory agencies and organizations, many of which are non-governmental, that perform important functions including development of global standards, certification of products, risk-management support, or provide third-party conformity assessment services.
The list below highlights a number of the agencies whose actions may affect PolyOne customers and communities.
National Sanitation Foundation (NSF)
NSF, an independent organization, develops national standards, provides learning opportunities through its Center for Public Health Education, and provides third-party conformity assessment services while representing the interests of all stakeholders. For more information, click here.
Underwriters Laboratories, Inc.
Underwriters Laboratories Inc. (UL) is an independent product safety certification organization that has been testing products, developing testing protocols and writing safety standards for over a century. For access to PolyOne’s UL listings, click here. Enter PolyOne for company name to see the listings.
Canadian Standards Association (CSA) International
CSA International is an independent product safety certification organization that helps achieve compliance with US and Canadian standards. For access to PolyOne’s CSA listings click here. Enter PolyOne for company name to see the listings.
The Plastics Pipe Institute
The Plastics Pipe Institute (PPI) is a major trade association representing all segments of the plastics piping industry. PPI promotes contemporary use of plastics piping for water and gas distribution, sewer and wastewater, oil and gas production, industrial and mining uses, power and communications, duct and irrigation. To access PolyOne’s listings click here. PolyOne PPI listings can be found on page 16, 17, & 47 of the current pdf document.
Food, Drug, Medical
PolyOne’s Good Manufacturing Practices (GMP) internal guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications. As an intermediate supplier, PolyOne’s manufacturing facilities are not required to register with nor be directly held to the FDA’s specific good manufacturing practice requirements.
PolyOne plays an important role in enhancing customer safety and has implemented internal GMP guidelines to help prevent products from being unintentionally adulterated. Modeled after FDA’s GMP requirements, these internal procedures include internal audit/reviews of all PolyOne’s manufacturing facilities involved in making products entering into food and/or drug markets including these elements:
- Raw material traceability and quality testing
- Good housekeeping procedures
- Pest control
- Good laboratory practices
- Hygiene policies
- Good documentation procedures
- Finished good quality testing
PolyOne plant personnel involved in making products for FDM use by our customers undergo initial and annual training on the particular processes and procedures involved in the manufacture of intermediate products for FDM markets. PolyOne currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes."
Drug Master Files
In support of our customer’s Device Master File submission for healthcare materials, PolyOne develops and maintains U.S. FDA Drug Master Files and Medical Application Files. Please contact your PolyOne customer service representative for additional information.