Polymer technologies manufactured under controlled conditions and ISO 13485-certified sites to meet strict regulatory requirements

Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety. 

¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.  

These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.

The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”

KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation 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 US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.

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 at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.

Get Help Now +1-866-737-2066 The PCF value of the TPEs was calculated using the ISO 14067:2018 standard and may be used as an input to determine the total greenhouse gas (GHG) emissions generated by a product over its entire life cycle.  

P1) ISO 2500 Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)