Geon(TM) DB5261 Neutral TT Iso Stable

White colorants for polyolefin containers and closures pre-tested to USP, EP, and ISO protocols

Global ISO Certificate Library

Global ISO Certificate Library

Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: based on polysulfone and PEEK resins with the capability of withstanding up to 1,000 autoclave cycles and high-heat sterilization at 150°C, these colorants are formulated with ingredient materials that have been successfully tested for ISO 10993 biocompatibility and are available in a line of bright and vivid transparent or opaque shades

主な特徴 • • • • • • ISO 13485の管理基準化で製造。規制対応 • • • 評価試験*: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材料) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 軽量化 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.

規制対応 • • • 評価試験：- ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

Certificate of Registration 9001:2015 MSP 9001:2015–MSP-ANAB-US (2.0) Page 1 of 2 Certificate of Registration of Quality Management System to ISO 9001:2015 The National Standards Authority of Ireland certifies that: Colorant Chromatics Ab Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland has been assessed and deemed to comply with the requirements of the above standard in respect of the scope of operations given below: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Additional sites covered under this multi-site certification are listed on the Annex (File No. 19.2540/C) Approved by: Geraldine LarkinChief Executive Officer Approved by: Lisa Greenleaf Operations Manager Registration Number: 19.2540/C Certification Granted: 1997年5月15日 Effective Date: Oct 20, 2018 Expiry Date: Oct 19, 2021 National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412 9001:2015–MSP-ANAB-US (2.0) Page 2 of 2 Annex to Certificate Number: 19.2540/C Scope of Registration: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Activity Location Central Management Group, Design, Manufacture Colorant Chromatics Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland File No.: 19.2540/C Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.

KEY CHARACTERISTICS • Customized density offering a wide range of specific gravities (1.2–11 gm/cm3) • Based on recycled resin from PIR and PCR sources • Broad modulus range, from very flexible to very rigid grades • Corrosion resistance that withstands oxidization for long-term use and benefit • Chemical resistance can be adapted depending on base resin as required • Provides visual surface effects, aesthetics, and cool touch • Design flexibility and processing ease MARKETS AND APPLICATIONS Applications in packaging and consumer goods in which a more sustainable solution is preferred: • Cosmetic caps and closures • Perfume caps • Spirit bottle caps • Luxury boxes • Handles and knobs SUSTAINABILITY BENEFITS • Formulated with recycled resin from post-industrial recycled (PIR) and/or post-consumer recycled (PCR) sources including ocean bound plastic waste • Reduces waste and supports the circular economy • Reduces carbon footprint compared to fossil feedstock alternatives • Simplifies manufacturing and lowers costs versus metal PRODUCT BULLETIN CHARACTERISTICS UNITS Gravi-Tech REC-CI GT5200-5089 PT Natural Gravi-Tech REC GT5200-5075 Black X2 Gravi-Tech REC GT5200-5078 Black Gravi-Tech REC GT5200-5079 Black Gravi-Tech REC GT5200-5060 Black Gravi-Tech REC GT5200-5057 Black Base Resin Ocean Bound rPP rPP rPP rPP rPP rPP Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral >95% PIR/Mineral >95% PIR+PCR/Mineral 30% PIR/Mineral 30% PIR/Mineral Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0 CHARACTERISTICS UNITS Gravi-Tech REC GT7300-5034 X2 FD Natural Gravi-Tech REC GT7300-5036 Black Gravi-Tech REC GT7300-5025 Black Gravi-Tech REC GT6000-5032 Black Gravi-Tech REC GT6000-5031 Black Base Resin ABS rABS/ABS rABS rPA6 rPA6 Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8 AVAILABLE GRADES Copyright © 2024, Avient Corporation.