Why specify medical grade polymers

Two words: confidence and compliance
Image of Tritan Medical Device

It is critical for designers of innovative medical devices and packaging to have access to high-performance medical grade materials.
To ensure patient safety and long-lasting reliability, manufacturers depend on medical grade material suppliers like Eastman—not only to provide advanced, high quality raw materials but also to have capabilities and systems that help comply with medical protocols and regulations. 

Manufacturers who specify medical grades of clear or opaque Eastman Tritan copolyester* know that Eastman will provide a high level of support throughout the regulatory journey to commercialization of a new product. Eastman’s world of experience helps ensure confidence and compliance in the areas of:
•  Biocompatibility—selected tests from the FDA-Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices”
•  Sterilization—test data for EtO, gamma, and e-beam sterilization methods
•  Quality systems—including current Good Management Practices and traceability processes
•  Dedicated regulatory support—global regulatory support to ensure compliance
•  Regulatory statements and Product Regulatory Information Sheets (PRIS)
•  FDA Drug Master Files
•  Quality systems and cGMP—complies with the requirements of ISO 9001 for the design, development, manufacture, and supply of polymers 
•  Application development and technical service—including but not limited to:
–   Educational webinars and customized lunch and learn sessions
–   Design recommendations
–   Material FFU criteria and specific performance testing
–   Competitive materials analysis or ID
–   Physical property testing
–   Aging and sterilization studies
•  Other supporting servicescontact your Eastman customer service representative
Why specify Eastman for your medical grade polymers? 
 Eastman has proven to be a reliable global supplier of raw materials—even proprietary materials like Eastman Tritan copolyester, which has no competition in the marketplace. Eastman has demonstrated leadership not only in innovation and business continuity but also regulatory support and processes that help customers take products to market with greater efficiency and confidence. 

*In addition to several medical grades of Eastman Tritan copolyester, Eastman offers medical grades of Eastar copolyester, Eastman Eastalite copolyester, Ecdel elastomers, and Tenite cellulosics.