https://www.avient.com/sites/default/files/2021-01/certificate-of-amendment-modification-avient-colorants-canada-inc.pdf
Certificate of Amendment
Loi canadienne sur les sociétés par actionsCanada Business Corporations Act
Certificat de modification
Avient Colorants Canada Inc.
942266-8
Corporate name / Dénomination sociale
Corporation number / Numéro de société
Raymond Edwards
Date of amendment (YYYY-MM-DD)
Date de modification (AAAA-MM-JJ)
Director / Directeur
2021-01-15
I HEREBY CERTIFY that the articles of the
above-named corporation are amended under
section 178 of the Canada Business
Corporations Act as set out in the attached
articles of amendment.
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- 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*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone Reference PE Base PP Base
Transparent
PP Base PEBA Base PC Base
Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.
https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
KEY CHARACTERISTICS
• Manufactured under change control principles
beyond CAS number (similar level as MEVOPUR
concentrates), reducing risk of change
• Free from animal-derived substances and
phthalates
• Suitable for blown film, injection molding,
blow molding and extrusion
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP chapters , including Class VI,
a requirement for ophthalmic and nasal drugs
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
- USP and USP light transmission
• Registered Drug Master File (Type III)
• Food contact compliance established with
FDA/EU*
APPLICATION BULLETIN
CARRIER
MATERIAL
PIGMENT
CONTENT/TYPE
LIGHT
FASTNESS
THERMAL
STABILITY
PRODUCT
CODE
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
Healthcare use limitations apply—see below.
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations
for Needle and Catheter Hubs
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
To help our customers meet healthcare industry
standards, Avient offers a range of standard colors
for needle hubs, canula hubs and wings matching
the color coding of the ISO 6009 standard.
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.
https://www.avient.com/sites/default/files/2021-01/clariant-plastics-coatings-usa-llc-de-amendment-change-of-name-jan-15-2021.pdf
Delaware
The First State
Page 1
5799827 8100 Authentication: 202256240
SR# 20210072080 Date: 01-11-21
You may verify this certificate online at corp.delaware.gov/authver.shtml
I, JEFFREY W.
BULLOCK, SECRETARY OF STATE OF THE STATE OF
DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT
COPY OF THE CERTIFICATE OF AMENDMENT OF “CLARIANT PLASTICS &
COATINGS USA LLC”, CHANGING ITS NAME FROM "CLARIANT PLASTICS &
COATINGS USA LLC" TO "AVIENT COLORANTS USA LLC", FILED IN THIS
OFFICE ON THE ELEVENTH DAY OF JANUARY, A.D. 2021, AT 10:39
O`CLOCK A.M.
AND I DO HEREBY FURTHER CERTIFY THAT THE EFFECTIVE DATE OF
THE AFORESAID CERTIFICATE OF AMENDMENT IS THE FIFTEENTH DAY OF
JANUARY, A.D. 2021.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Plan%2520Summary.pdf
Contacts
Public Contact
First Name: * Brian
Last Name: * Greer
Position: * EHS Manager
Telephone: * 5192150535
Ext
Fax
Email: * brian.greer@polyone.com
Person responsible for the Toxic Substance Reduction Plan preparation
First Name: * Darryl
Last Name: * Chartrand
Position: * Senior Air Quality Technologist
Telephone: * 4164999000
Ext 73642
Fax 4164994687
Email: * darryl.chartrand@ch2m.com
Employees
Employees
Number of Fulltime Employees: *
16
Copy of Certifications of Plan
Copy of Certifications of Plan
Upload Document
A copy of the certification statement(s) from the Highest Ranking Employee and the Licensed Planner(s), for the Toxic Substance Reduction
Plan for which the Plan Summary is being submitted are required.
Please upload a single document containing all certifications.
Do not upload any certification statements that are dated after December 31.
https://www.avient.com/sites/default/files/2021-01/tax-certificate-avient-pakistan-private-limited.pdf
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性
生产符合高于CAS编号级别的变更控制原则
(与MEVOPUR母粒类似),降低变更风险
不含动物源性物质和邻苯二甲酸盐
适用于吹膜、注塑、吹塑和挤出
•
•
•
注册药品主文件(III型)
食品接触符合FDA/EU*要求
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章,包括VI级别,符合眼
科和鼻腔用药物要求
- 欧洲药典3.1.3/3.1.5(聚烯烃)
- 美国药典(聚乙烯)
- ICH Q3D 杂质元素
- USP和USP,透光率
•
•
•
载体材料 耐光性 热稳定性 产品代码颜料含量/类型
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
适用医疗保健使用限制—见下文。
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/resource-center?document_subtype=0&document_type=221&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.