PolyOne's FDM Program

PolyOne Corporation has announced that continuous updates to its ongoing Food, Drug and Medical/Good Manufacturing Practices (FDM/GMP) program are helping medical devices keep pace with the ever changing regulatory environment. This program helps medical device manufacturers to comply with FDA and cGMP (current Good Manufacturing Practice) requirements by providing material solutions aligned with the same specifications.

Larry Johnson, PolyOne global healthcare marketing director, says, “Since PolyOne’s inception, we have been supplying materials to the healthcare industry, and have been updating our FDM/GMP program on a regular basis to keep our specialty healthcare polymers in line with up-to-the-minute requirements. We are providing medical device manufacturers with greater control and risk minimization, because the materials are created in an environment that meets the highest quality standards demanded by this market.”

FDM/GMP procedures and audits go beyond ISO 9001-2000 procedures. The PolyOne program includes specific rules regarding housekeeping, clothing and hygiene, production and operations, raw material traceability, dust control, quality systems and quality testing controls, as well as controls to guard against cross-contamination with heavy metals or other non-formula substances. In addition, plant production personnel and commercial development, sales and marketing personnel are trained on an ongoing basis concerning FDM procedures and compliance with these rules.

Currently in place at 15 PolyOne global manufacturing sites, the program helps PolyOne’s products meet and exceed the needs of medical device manufacturers. These qualified plants are internally audited for consistency on a regular basis.

About PolyOne
PolyOne Corporation, with 2008 annual revenues of $2.7 billion, is a premier provider of specialized polymer materials, services and solutions. Headquartered outside of Cleveland, Ohio USA, PolyOne has operations around the world. For additional information on PolyOne, visit our Web site at www.polyone.com.