Food and Drug Administration (FDA) regulations.

Food and Drug Administration (FDA) regulations.

Coring refers to the tiny fragments of material sheared off by the needle as it penetrates the stopper or septum, which could potentially contaminate the drug inside the container.

Most TPEs fall into the Food and Drug Administration’s Generally Recognized as Safe (GRAS) category. At Avient, we use a collaborative approach to deliver the specialty polymer formulations, services and sustainable material solutions specific to your application and property needs.

Documented change control beyond CAS number is practiced and Registered Drug Master File (DMF) / Device Master File (MAF) documentation is maintained. 

REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.

KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.

This new system also delivers up to 99% product recovery when used in conjunction with our FlexCart volumetric dosing equipment.” Easy to transport, handle and store, this packaging system improves material handling safety while still efficiently delivering the high quality colorant stored within it.

Javier has the experience and ability to create progressive sourcing strategies and deliver on their execution,” said Mr. Going forward, I’m fully confident he will generate and deliver even greater value for us and our stakeholders.”

The material delivers elevated performance – including long term aging, chemical resistance and low compression set – to numerous markets for a broad range of applications. PHOTO CAPTION: Licensing Fortrex™ technology from Cooper Standard enables PolyOne to deliver elevated performance to numerous markets for a broad range of applications.