https://www.avient.com/sites/default/files/2023-12/Certificado ISO 9001 Avient Brasil-UPdated.pdf
A validade deste certificado é baseada em auditorias periódicas do sistema de gestão definido pelo escopo
acima e está condicionada à notificação por escrito ao ABS Quality Evaluations, Inc. de mudanças
significativas no sistema de gestão ou seus componentes.
Francisco Nakasato, 1700
Bairro São Roque das Chaves
Itupeva, SP 13295-000
Brasil
ISO 9001:2015
O Sistema de Gestão da Qualidade é aplicável a:
Certificado No: 49862
Data de Expiração Anterior: 09 Abril 2020
Data de Aprovação Original: 16 Abril 2014
Data de Certificação: 13 Abril 2020
Data Efetiva: 06 Abril 2023
Data de Expiração: 09 Abril 2026
Data de Emissão: 06 Abril 2023 Dominic Townsend, Presidente
DEVELOPMENT, PRODUCTION, SALES AND TECHNICAL ASSISTANCE OF LIQUID COLORANTS, COLORS
CONCENTRATES AND ADDITIVES FOR THE PLASTICS, FIBERS AND RUBBER MARKET IN GENERAL
DESENVOLVIMENTO, PRODUÇÃO, VENDAS E ASSISTÊNCIA TÉCNICA DE COLORANTES LÍQUIDOS,
CONCENTRADOS DE CORES E ADITIVOS PARA O MERCADO DE PLÁSTICOS, FIBRAS E BORRACHAS EM GERAL.
Certificado de Conformidade
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
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.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
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.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma 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 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.
https://www.avient.com/sites/default/files/2025-01/Hiformer Liquid Masterbatches Case Study Snapshot_Portuguese.pdf
FA B R I C A N T E DE
E M B AL AG E N S
FA R M AC Ê U T I C AS
G A R R A F A S Â M B A R
• Garantir a conscientização sobre os padrões e requisitos
de conformidade aplicáveis
• Fornecer opções de matéria-prima que estejam alinhadas
com os padrões brasileiros de embalagens farmacêuticas
• Aderir às Boas Práticas de Fabricação (BPF)
• Colaborou em toda a cadeia de suprimentos
para garantir que as necessidades
regulatórias de matéria-prima fossem
atendidas
• Avaliação da conformidade das matérias-
primas com os padrões brasileiros de
embalagens farmacêuticas
• Material produzido sob os requisitos de BPF
Hiformer Liquid Masterbatches
PRINCIPAIS REQUISITOS
POR QUE A AVIENT?
https://pt.avient.com/products/polymer-colorants/liquid-color-concentrates/hiformer-liquid-masterbatches
Slide 1: Fabricante de embalagens farmacêuticas
https://www.avient.com/sites/default/files/2021-09/supplier-code-of-conduct-fr.pdf
La mise en œuvre
de ces normes en termes de performance des fournisseurs est importante pour nous, et nous attendons de nos fournisseurs
et partenaires commerciaux qu’ils communiquent ces attentes tout au long de leur chaîne d’approvisionnement en adoptant
des systèmes de gestion, des politiques, des procédures et une formation efficaces pour respecter les normes et les attentes
énoncées dans ce code de conduite des fournisseurs au sein de leurs opérations commerciales.
S’abstenir d’offrir de l’argent, des prêts, des crédits,
des remises préjudiciables, des cadeaux, des produits
ou des services à des collaborateurs d’Avient pour
leur usage ou leur avantage personnel.
Éviter les conflits d’intérêts qui impliquent des relations
commerciales avec des membres de la famille et des
amis personnels proches chez Avient.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for Medical Devices 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
• 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.
https://www.avient.com/sites/default/files/2020-08/stan-tone-epx-product-bulletin.pdf
% Pigment Specific Gravity Color Index Lightfastness
WHITE
10EPX03 Titanium Dioxide, Rutile 57 1.95 PW-6 I/O
YELLOW
12EPX01 Diarylide AAOT GS 25 1.22 PY-14 I
12EPX03 Diarylide HR RS 20 1.2 PY-83 I/O (Mass)
13EPX02 Isoindolinone RS 30 1.3 PY-110 I/O
13EPX03 Benzimidazolone GS 40 1.27 PY-151 I/O (Mass)
81EPX01 Iron Oxide 40 1.62 PY-42 I/O
ORANGE
15EPX03 Benzimidazolone 30 1.26 PO-36 I/O
RED
23EPX04 Quinacridone BS 25 1.21 PV-19 I/O
23EPX06 Specialty Naphthol BS 30 1.21 PR-170 I/O (Mass) C
25EPX01 Red 2B, Ca Salt Bs 24 1.27 PR-48:2 I/O (Mass)
28EPX01 Red 2B, Ba Salt YS 23 1.29 PR-48:1 I/O (Mass)
82EPX01 Iron Oxide, Light BS 40 1.67 PR-101 I/O
82EPX02 Iron Oxide, Dark BVS 40 1.68 PR-101 I/O
82EPX04 Iron Oxide, Light VYS 40 1.67 PR-101 I/O
BLUE
40EXP03 Phthalocyanine GS 25 1.25 PB-15:3 I/O
40EXP05 Phthalocyanine RS 25 1.25 PB-15:3 I/O
42EXP02 Ultramarine 50 1.54 PB-29 I/O
49EXP01 Cobalt 50 1.83 PB-28 I/O
GREEN
50EPX02 Phthalocyanine BS 18 1.34 PG-7 I/O
50EPX03 Phthalocyanine YS 25 1.42 PG-7 I/O
59EPX01 Chromium Oxide 40 1.64 PG-17 I/O
VIOLET/MAGENTA
24EPX03 Quinacridone Violet 15 1.2 PV-19 I/O
24EPX04 Ultramarine Violet 50 1.66 PV-15 I/O
24EPX05 Quinacridone Magenta 20 1.21 PR-122 I/O
24EPX06 Benzimidazolone 20 1.2 PV-32 I/O
24EPX07 Carbazole Violet 15 1.2 PV-23 I/O
BROWN/TAN
83EPX01 Iron Oxide, Light 39 1.64 PBr-6 I/O
83EPX02 Iron Oxide, Dark 40 1.66 PBr-6 I/O
BLACK
90EPX01 Furnace - High Jet 14 1.23 PBk-7 I/O
90EPX04 Furnace - Medium 20 1.25 PBk-7 I/O
90EPX05 Iron Oxide 50 1.77 PBk-11 I/O
EPX
RS = Red Shade
YS = Yellow Shade
VYS = Very Yellow Shade
BS = Blue Shade
VBS = Very Blue Shade
GS = Green Shade
HR = Heat-Resistant
LIGHTFASTNESS
I = Indoor Only
I/O = Indoor or Outdoor
Mass = Outdoor Masstone
Application Only
C = Some Caution Advised
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2022-02/Sustainability ESG Disclosures_Antimony Trioxide.pdf
DOCUMENT NUMBER_ SSS-003
CATEGORY DETAIL
EC Number 215-175-0
CAS Number 1309-64-4
Name Subclass 1 Antimony Trioxide (ATO)
Structural Formula
CHEMICAL IDENTITY
PROPERTY DETAIL
Physical State Solid
Form Powder
Color White
Odor Odorless
Melting Point 656°C
Boiling Point 1425°C
Bulk Density 5.20 g/cm3
Water Solubility Slightly Soluble
PHYSICAL/
CHEMICAL
PROPERTIES
DOCUMENT NUMBER_ SSS-003
HEALTH EFFECTS
HUMAN HEALTH SAFETY ASSESSMENT
Consumer
It is very unlikely that consumers would be exposed to ATO in its concentrated
form because it is only sold for industrial use to make polymers and other products
and is not sold directly to consumers.
https://www.avient.com/sites/default/files/2021-01/virtual-reality-application-bulletin.pdf
DEFENSE
• Battlefield
simulation
• Flight & vehicle
simulation
• Medic training
• Virtual bootcamp
CO
NS
UMER
E
DU
CA
TION
• Video games
• Live events
• Video entertainment
• Theatre
• Virtual theme parks
• Virtual museums
& galleries
• Virtual
immersion
• Global
connectivity
H
EALTHCARE
• Surgical
simulation
• Phobia treatment
• Robotic surgery
• Skills training
• Diagnostics
R
ETAIL & FASHIO
N• Virtual stores
• 3D human forms
for design
• 3D fashion
portfolios
REAL ESTAT
E
E
NG
INEERING
• 3D modeling
tools
• Design tools
• Prototyping
• Construction
• Architectural
design
• Virtual tours
1.844.4AVIENT
www.avient.com
Copyright © 2020, Avient Corporation.