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.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2025-01/ISO 16949 Tossiat%2C France.pdf
Date Of Certification: 11 December 2024
Date Of Expiration: 10 December 2027
IATF Certificate N°: 0558656
Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1
For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France
(The official document is in English.
Any translations of this document shall be used for reference only.)
1/2
Certificate of Approval
AWARDED TO
PolyOne France Tossiat
Route de la vavrette, 01250, Tossiat - France
IATF USI: LWZS4P
Bureau Veritas Certification certify that the Quality Management System of the above
organisation has been audited and found to be in accordance with the requirements of
IATF 16949 - FIRST EDITION
and the applicable customer specific requirements
SCOPE
Design and manufacturing
PERMITTED EXCLUSION(S)
None
PRODUCT(S) DELIVERED
colour with additive concentrates for thermoplastic resins and speciality compounds
obtained by mixing and extrusion
https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX
Date Of Certification: 11 December 2024
Date Of Expiration: 10 December 2027
IATF Certificate N°: 0558656
Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1
For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France
(The official document is in English.
Any translations of this document shall be used for reference only.)
2/2
Appendix to the Certificate of Approval
AWARDED TO
PolyOne France Tossiat
Route de la vavrette, 01250, Tossiat - France
IATF USI: LWZS4P
REMOTE SUPPORT FUNCTION(S)
NAME ADDRESS SCOPE
AVIENT LUXEMBOURG
19, Route de bastogne,
9638, Pommerloch -
Luxembourg
IATF USI: GAZS9A
Purchasing, Logistics, Supplier
Management
PolyOne Europe Logistics
7 Rue bleriot, 4460,
Grace-Hollogne - Belgium
IATF USI: P4WA4Y
Warehousing
Polyone Poland
Ul. wschdnia 6, 99-300,
Kutno - Poland
IATF USI: C4W5ZL
Logistics
https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX
2024-12-13T10:07:11+0100
Authenticity and Integrity
https://www.avient.com/sites/default/files/resources/Novel_Thermoplastic_Elastomers_with_Universal_Bonding_Characteristics.pdf
This paper concentrates on a new class of TPEs
that can bond to a number of substrates with dissimilar surface energy or polarity, such as PP, ABS, PC and
COPE, etc., called “universal overmolding TPE.”
Also, this new technology can reduce
cost by reducing the number of TPEs needed for different applications.
The substrate is locked in its
place on wheels in order to maintain the 90o angle as the elastomer is pulled.
https://www.avient.com/sites/default/files/2022-04/Avient Q1 2022 Earnings Release.pdf
To participate in the audio-only portion of the call, dial 1-844-835-
7433 (domestic) or 1-914-495-8589 (international) and provide conference ID number 4774915.
To listen to this recording, dial 1-855-859-
2056 (domestic) or 1-404-537-3406 (international) and provide conference ID number 4774915.
They are based on management’s
expectations that involve a number of business risks and uncertainties, any of which could cause
actual results to differ materially from those expressed in or implied by the forward-looking
statements.
https://www.avient.com/sites/default/files/2022-08/Environmental Stress Cracking Resistance _ESCR_ Design Guide %281%29.pdf
The maximum height should be about 2 .5 times
the nominal wall thickness (2 .5W) .
Holes are placed in a part for either
structural support or cosmetic reasons .
If the holes are not for structural design, they
can be placed closer together and should all be
placed two times the nominal wall thickness (W)
apart from each other and from an outside or
inside wall .
https://www.avient.com/sites/default/files/2024-03/Terms and Conditions of Sale for Switzerland.pdf
Furthermore, the parties agree that
Seller’s performance under these Terms shall not be an acceptance
of any of Buyer’s terms and conditions.
2.
No
statement of agreement, oral or written, made before or at the
formation of the contract shall vary or modify the written terms
hereof, and neither party shall claim any amendment, modification
or release from any provision hereof unless such change occurs in a
writing signed by the other party and specifically identifying it as an
amendment to the contract.
The exclusive place of
jurisdiction for any dispute, claim or controversy arising under, out
of or in connection with or related to these Terms and the contract
they form part of (or subsequent amendments thereof), shall be the
place of the registered seat of the Seller in Switzerland.
22.
https://www.avient.com/sites/default/files/resources/GHS%2520MSDS%2520Updates%2520Letter.pdf
Existing, current MSDSs will continue to reside in our system for the time being, as we cannot
convert all to the new format immediately.
As new formulations are developed, the new format will be
employed, and a GHS SDS will be generated and sent, replacing the previous MSDS in our system.
By the
deadline of June 2015 for North America and Europe, all MSDSs in these regions will have been converted to
the new format SDS.
https://www.avient.com/idea/3-ways-thermoplastic-elastomers-can-help-you-hit-right-notes-portable-speakers
2.
To integrate them, TPEs enable an overmolding process that places the material directly onto the housing substrate.
https://www.avient.com/content/challenge-us
Creating a Great Place to Work
That’s what makes us one of the world’s great places to work.
https://www.avient.com/sites/default/files/resources/TPE_Overmolding_Solutions_for_Engineering_Thermoplastics.pdf
The substrate is locked in its place on wheel in order to maintain the 90o
angle while the elastomer is being pulled.
Reduce the potential of peeling and provide a sharp transition between the
TPE and the substrate.
2.
The developed overmolds TPE compounds have already been used to make
parts for a number of application areas i.e., personal care, hand held-electronics,
powertools and housewares.