https://www.avient.com/sites/default/files/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
1/1
Certification/Renovation Audit: 14-10-2022
Original approval date:
- 1
Bureau Veritas Iberia S.L.
Certificate Number:
Certificate expiration date:
Effective date: 31-10-2022
30-10-2025
Expiry date of previous cycle: 30-10-2022
31-10-2016
ES133794
Scope of certification:
MANUFACTURING OF MASTERBATCHES, ADDITIVES
AND COMPOUNDS FOR PIGMENTING THERMOPLASTIC
MATERIALS USED IN FOOD INDUSTRY
ISO 22000:2018
POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN -
NAVARRA - ESPAÑA
AVIENT ESPAÑA, S.L.
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/2023-01/ECCOH XL Cross-Linkable Solutions for Photovoltaic Cable _8148_ Product Bulletin.pdf
They have outstanding UV and weather resistance,
passing Arrhenius lifetime prediction tests of
20,000 hours as per the IEC 60216-1 standard.
They
pass EN 50618 and IEC 60332-1 standards on
the assembled cable (if the cable jacketing and
insulation are both produced with ECCOH XL
8148 solutions).
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
HYPODERMIC NEEDLE
MANUFACTURER
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-11/eccoh-product-selection-guide-en.pdf
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/sites/default/files/2023-05/SG Liner for Pipe Replacement - Case Study.pdf
SOURCE:
Repurposing gas infrastructure for hydrogen | 2020 Siemens
Energy Global (siemens-energy.com)
© 2023, All Rights Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
https://www.fiber-line.com/en/
https://www.siemens-energy.com/global/en/news/magazine/2020/repurposing-natural-gas-infrastructure-for-hydrogen.html
https://www.siemens-energy.com/global/en/news/magazine/2020/repurposing-natural-gas-infrastructure-for-hydrogen.html