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.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
https://www.avient.com/sites/default/files/resources/ISO9001.2015PolyOneShanghai%25282018-2021%2529.pdf
ZWOLSEWEG 1, 2994 LB, BARENDRECHT, NETHERLANDS.
Park, Pudong, Shanghai, China, 201203
and the sites as mentioned in the appendix accompanying this certificate
has been found to conform to the Quality Management System standard:
ISO 9001:2015/GB/T 19001-2016
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
C ertificate No: 7071-1998-AQ-RGC-RvA
P lace and date: Shanghai, 30 March, 2018
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV GL Business Assurance B.V., ZWOLSEWEG 1, 2994 LB, BARENDRECHT, NETHERLANDS.
https://www.avient.com/sites/default/files/2020-08/gravi-tech-closures-case-study-spanish.pdf
De
hecho, un informe llamado “El empaque importa”
(Packaging Matters™) realizado en 2015 por la compañía
MeadWestvaco, indica que más del 25% de los
consumidores de bebidas alcohólicas dicen que el
empaque es “muy” o “extremadamente” impactante en
su decisión de compra de un producto.
El cambio de moldeado de metal a moldeado por
inyección también permitiría el ahorro en el costo de
procesamiento y un aumento en la libertad
de diseño.
EL IMPACTO
El equipo del productor de empaques cambió al material
Gravi-Tech y registró inmediatamente un ahorro en
costos de 35% debido a costos menores en el material
y procesamiento.
https://www.avient.com/sites/default/files/resources/ISO14001.2015PolyOneShanghai%25282018-2021%2529.pdf
ZWOLSEWEG 1, 2994 LB, BARENDRECHT, NETHERLANDS.
Park, Pudong, Shanghai, China, 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2024-10/ISO9001证书 %28英文版%29 -2024.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
462307-2021-AQ-RGC-RvA
Initial certification date:
23 June 2021
Valid:
24 June 2024 – 23 June 2027
This is to certify that the management system of
Avient China Company Limited
No. 188, Quanzhou Road, Zhongxin Suchu High-Tech Industrial Development Park, Chuzhou,
Anhui, China
has been found to conform to the Quality Management System standard:
GB/T 19001-2016 / ISO 9001:2015
This certificate is valid for the following scope:
Design and Manufacture of Color Concentrates, Filling Concentrates and Additive
Concentrates
http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2021-04/shanghai-14001.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands.
Park, Pudong, Shanghai, China, 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/resources/Tangerang_ISO22000.pdf
Kalisabi No. 1,
Kec.
Cibodas
Kecamatan Cibodas, Tangerang 15138
Indonesia
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46391 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Madesqs.ch
F.
https://www.avient.com/company/policies-and-governance-0/copyright-legal-disclaimer
Global ISO Certificate Library
https://www.avient.com/company/sustainability/performance/eps-expansion
Global ISO Certificate Library
https://www.avient.com/news/avient-expands-production-nymax-rec-recycled-nylon-formulations-istanbul
PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067