They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need   Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring

Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard Solutions compliant with USP Class VI and ISO-10993 regulations

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.

PC (ISO) WHITE CC DOWNY BLUE 1 DOWNY BLUE 1.B

1/1 Certification/Renovation Audit: 14-10-2022 Original approval date: - 1 Bureau Veritas Iberia S.L. Certificate Number: Certificate expiration date: Effective date: 31-10-2022 30-10-2025 Expiry date of previous cycle: 30-10-2022 31-10-2016 ES133794 Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRY ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.

Global ISO Certificate Library

Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.

They have outstanding UV and weather resistance, passing Arrhenius lifetime prediction tests of 20,000 hours as per the IEC 60216-1 standard. They pass EN 50618 and IEC 60332-1 standards on the assembled cable (if the cable jacketing and insulation are both produced with ECCOH XL 8148 solutions).