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.

PRODUCT SPECIFICATION PRODUCT BULLETIN CARRIER PVC Recommended % of use 1% Temperature resistance 200°C Dispersion - abaque Avient ≤ 2 Copyright © 2022, Avient Corporation.

MEVOPUR COLORANTS • Standard colors in PP and PE to shorten time-to-market • Custom colors matched to Pantone, RAL or other color reference • White colorants for pharmaceutical packaging for LDPE, HDPE and PP with opacity to reach USP chapter MEVOPUR FUNCTIONAL ADDITIVES • Antistatic formulation with good flow/impact for injection molding • Amide- and amine-free antistatic for film in contact with API (Active Pharmaceutical Ingredients) • UV blocking for transparent PP and PE packaging to meet USP chapter • Non-migrating friction reduction/processing aid for PE and PP • Laser marking/welding additive for fast, reliable marking/assembly • MVTR (Moisture Vapor Transmission Rate) reduction for HDPE to improve shelf-life • Thermal protection of the polymer during processing • Gamma/e-beam sterilization protection for PP (up to 50kGy) with color compensation for reduced yellowing 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 Bormed™ is a registered trademark of Borealis 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.

The additives are delivered as concentrates to use with a let- down ratio of typically 1 to 4% or as ready-to-use formulations to use without further dilution.

PMMA Considering lens performance, Resilience™ LS Frost PVC offers properties and material performance similar to PMMA, often at a significantly lower cost. 1 ASTM D-1003 measured by Polymer Diagnostics, Inc.

For and on behalf of BSI: Carlos Pitanga, Chief Operating Officer Assurance – Americas Certification Date: 2018-07-11 Latest Issue: 2018-07-11 Expiry Date: 2021-07-10 BSI Certificate Number: 85585 IATF Number: 0315491 Page: 1 of 2 This certificate remains the property of BSI and shall be returned immediately upon request.

主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方，提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别，降低变 更风险 不含动物源性物质和邻苯二甲酸盐 可用作各种聚合物的母粒或即用型配方 为方便起见，可在一个产品中实现功能性和颜 色的组合 法规支持 经过预测试的原材料： - ISO 10993-1 - USP 第、章（VI类） - USP （指南），6.2.3 可萃取元素； USP - ICHQ3D/USP 2 可萃取金属 - 欧洲药典 3.1 聚烯烃（如适用） FDA发布的注册药品主文件（III类）和/或医疗 器械主文件 为符合（新）法规（如IVDR）的批准或过渡提 供文档支持 适用医疗保健使用限制—见下文。 在不限制本声明的一般性的情况下，不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用： (1) 接触人体组织或体液长达30天或更长时间； (2)“整形”（整容或重建）手术； (3) 生殖植入物或任何节育器械；或者 (4) 用于支持或维持人类生命的永久性（超过30天）植入式医疗器械中的任何关键组件。

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 • Available as additive concentrates, ready-to-use additive formulations or ready-to-use additive/ colorant formulations for different polymers 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; exceptions may occur Healthcare use limitations apply—see below.