https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
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
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*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
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 USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2024-05/Cesa Flame Retardant Additives Product Bulletin %281%29.pdf
Manufacturers have the ability to design and
validate to meet UL criteria, and FM approval
standards, including:
• UL94 V-0 • UL94 HB
• UL94 V-1 • UL94 5VA
• UL94 V-2 • UL94 5VB
• UL2335 • FM4998
NON-HALOGENATED CHOICES
In addition to standard halogenated options,
Cesa Flame Retardant Additives are also available
as non-halogenated formulations.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
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https://www.avient.com/sites/default/files/2021-06/inscripcion-registro-santiago-cambio-razon-social-performance-masterbatches618874v1.pdf
Santiago, 3 Junio 2021
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Documento incorpora Firma
Electronica Avanzada
Código de Verificación: cec_1c0abd-0 pagina 2 de 2
EDUARDO JAVIER DIEZ MORELLO
2021-06-03T10:28:54-0600
Santiago
Firma Electrónica Notario
2021-06-04T10:37:47-0400
https://www.avient.com/sites/default/files/2024-09/Maxxam FR Polyolefin Formulations - Product Overview.pdf
Temp (HDT 0,45 MPa) °C 60–100 80–145 80–160 40–80 60–120 60–110 60–100 80–145 80–145 40–80 60–120 60–110
Flammability, UL94 Step V2-V0/5VA V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0
Glow Wire
Flammability Index °C 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960
CTI V 450–00 450–600 450–600 450–600 450–600 450–600 350–600 350–600 350–600 350–600 350–600 350–600
Oil Resistance – + + + + + + + + + + + +
Drying Required – Y Y Y Y Y Y Y Y Y Y Y Y
Process (IM, EX, BM)1 – (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX)
Other Modifications2 – Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM Impact, HS,
UV, LM GF, HS, UV, LM Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM
Descriptions
Lower density
with moderate
strength.
Good
chemical
1 IM: Injection Molding, EX: Extrusion, BM: Blow Molding
2 HS: Heat Stabilized, UV: UV Stablized, LM: Lasermarking.
https://www.avient.com/sites/default/files/2024-10/Replacing Aluminum with Long Fiber Thermoplastics _LFT_ Application Bulletin.pdf
Evaluating
a metal substitution involves two primary factors:
1) the difference in processing methodologies, and
2) the material capabilities.
Though the upfront
tooling costs can be high, the investment can yield a
life expectancy of 100,000 to over 1 million cycles.
https://www.avient.com/sites/default/files/2024-09/Terms and Conditions of Sale for Germany.pdf
ACCEPTANCE 1.
Terms and Conditions (October 1, 2024) Allgemeine Geschäftsbedingungen (1.
Oktober
2024)
1.
https://www.avient.com/sites/default/files/2022-09/FR Healthy Bldg Codes Application Snapshot.pdf
PROFILE/SHEET EXTRUDER
R A I L S A N D K I C K P L A T E S
• Convert existing PVC profile and sheet rails and kick plates to
polyolefin resin to meet Class A fire safety (ASTM E84)
• Provide a system that meets healthy building certifications
and approvals
• Utilize a more sustainable flame retardant technology,
removing brominated or halogenated flame retardants from
the environment
• Achieve non-compromising performance in aesthetics,
impact, dimensional stability, CLTE, and E84 testing
• Provided broad flame retardant platform, backed by
extensive application and industry expertise, to meet
global flammability standards
• Has largest UL94 recognized Prospector membership
with HB, V-0, V-1, V-2 and 5VA/5VB ratings, and broad
glow wire performance products
• Included in-house UL certified labs and manufacturing
locations to perform UL94 material sampling and testing
• Supported application development to meet fire safety
standards, address current or emerging healthy building
codes, smart home requirements, and LEED credits
• Offered custom formulations in small lot quantities
Cesa™ Flam Non-Halogen Flame Retardants
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-03/63431-ECert.pdf
ECert.QECertificate
Page 1 of 2
Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon
prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.