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Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf

https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Color can be combined with additives to enhance performance and protection 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 Device Master File • Food contact established with FDA/EU* NOMINAL OUTSIDE DIAMETER OF NEEDLE (MM) COLOR DESCRIPTION RAL PANTONE TRANSPARENT PRODUCT CODE OPAQUE PRODUCT CODE 0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127 0.45 Brown 8017 7588 C PP8M665294 PP8M665296 0.5 Orange 2003 173 C PP2M665298 PP2M665300 0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292 0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896 0.7 Black 9005 Black C PP9M664950 PP9M664952 0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689 0.9 Yellow 1021 115 C PP1M665211 PP1M665213 1.1 Cream 1015 7401 C PP0M665290 PP0M665292 1.2 Pink 3015 502 C PE3M665725 PP3M665727 Healthcare use limitations apply—see below.

Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf

https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal- derived substances • Standard concentrates in a PE carrier and on request in PP • Pre-colored formulations can be supplied in specific resins selected for the application 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) • Food contact established with FDA/EU* APPLICATION BULLETIN DRUG TYPE COLOR DESCRIPTION PANTONE REFERENCE AVIENT PRODUCT CODE PE BASED Adrenergic agonist combinations Light Green 373 C PE6M176349 Adrenergic agonists Purple 2583 C PE4M176057 Anti-infectives Tan 467 C PE8M176130 Anti-inflammatory, nonsteroidal Grey Cool Grey 4 C PE7M176184 Anti-inflammatory, steroids Pink 197 C PE3M176237 Anti-inflammatory, immunomodulators Olive Green 5763 C On request Beta-blockers Yellow Yellow C PE1M176160 Beta-blocker combinations Dark Blue 281 C PE5M176272 Carbonic anhydrase inhibitors Orange 1585 C PE2M176089 Cytotoxic Black 6 C PL9M176008 Miotics Dark Green 348 C PE6M176267 Mydriatics and cycloplegics Red 1797 C PE3M176236 Prostaglandin analogues Turquoise 326 C PE5M176273 Healthcare use limitations apply—see below.

ColorMatrix Smartheat RHC Technical Bulletin.pdf

https://www.avient.com/sites/default/files/2025-03/ColorMatrix Smartheat RHC Technical Bulletin.pdf

EU FDA Mercosur SmartHeat RHC Yes Yes Yes PACKAGING Package Type Quantity 5G Pail Up to 40 lbs Planetpak Up to 40 lbs Test Description Test Method Units Typical Values Viscosity Avient Method cP 6,000–10,000 Density Avient Method Lbs/gal 7.9–8.9 Color Variance Avient Method ∆E 0.0–1.0 Color Appearance Visual — Slight Blue Dispersion Pressout Visual — Pass Opacity: Visual Visual — Pass TYPICAL GENERAL PROPERTIES1 1Typical values are not to be construed as specifications.

Polymer Products: Colorants, Additives & Formulations

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