https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience 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 • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.
FUNCTIONALITY TARGET APPLICATIONS BLOOD COLLECTION REAGENT CONTAINERS/ KITS PIPETTE/ LABWARE SELF-TESTING/ POCT INSTRUMENT/ ACCESSORIES Colorants for coding for lab automation/ identification Wide range of colors in various polymers, available in ready-to-use formulation or concentrate adapted to your process Colors – low migration/ interference Ready-to-use formulation to avoid interference with analytical tests; extractable metal data Colors – biologically evaluated Reduced risk of non compliance to current and proposed regulations such as IVDR Color in PP, ABS, PC and high temperature polymers with UL listings Ready-to-use solutions/concentrates supporting Underwriters Laboratory requirements of electric enclosures Antistatic for PP, ABS, PC/ABS Permanent/non-migrating ready-to-use formulation; fast decay time independent of % relative humidity Clarifying PP Sorbitol-free, minimizing potential migration Laser marking for UDI replacing ink printing/labels Activation of the polymer to laser energy give high contrast solvent-free, high speed identification Laser welding for fast, reliable assembly of a range of polymers Custom concentrates and ready-to-use formulations for optically transparent and opaque colors while allowing laser transmission/absorption Nucleation of semicrystalline polymers e.g.
https://www.avient.com/sites/default/files/2021-10/information-systems-use-policy-final-9.1.2021.pdf
EXPECTATIONS FOR USE OF INFORMATION SYSTEMS Users shall: • Use all Information Systems consistent with their intended purpose, Avient business objectives, and the Code of Conduct; • Take necessary steps to prevent unauthorized access to and maintain security of Confidential Data; • Use only approved and secured methods when sharing Confidential Data and ensure recipients have authorization to receive Confidential Data and/or have obtained prior approval from User’s manager; and • Obtain approval from Avient’s Information Technology department before procuring, installing, connecting, using, or decommissioning software, systems, applications, or non- Avient devices to or from Information Systems, including, but not limited to, on premise and cloud-based systems.
PROHIBITED USES OF INFORMATION SYSTEMS Users shall not use Avient Information Systems for any of the following prohibited uses: • Any activity prohibited by applicable law; • Violating Avient Ethics and Corporate Policies; • Infringing on the intellectual property rights of another individual or company; • Soliciting for activities or products unrelated to Avient’s business interests in furtherance of an independent business; • Improper or unauthorized use of email and email distribution lists, including mass or unsolicited emails (such as chain letters) and forging email header information or signatures; • Exporting, transferring, downloading, copying, or saving Confidential Data or Information Systems to non-approved devices or locations; • Intentionally introducing security threats to Information Systems or effecting a Cyber or Data Incident; or • Engaging in any other activity similar to the above that, in Avient’s reasonable judgment, is disruptive to or not in the best interests of its business.
Personal Data additionally includes any non-Avient data of a private nature, such as login information for personal email, social media, or subscription service accounts, personal documents, and notes.
https://www.avient.com/sites/default/files/2020-11/cotrep-at-20-21-avient-corporation-cesar-ir-pe-94000828.pdf
L’avis porte sur la détectabilité et la triabilité de la solution colorante et non sur la recyclabilité de l’emballage au global.
Les emballages non détectables lors de cette étape de tri sont orientés vers les refus des centres de tri pour une valorisation énergétique.
La solution colorante noire CESA® IR PE 94000828 de Avient Corporation utilisée pour colorer des emballages rigides en PP est une alternative aux solutions colorantes non détectables.
https://www.avient.com/sites/default/files/2020-11/cotrep-at-20-20-avient-corporation-cesar-ir-pp-94000721.pdf
L’avis porte sur la détectabilité et la triabilité de la solution colorante et non sur la recyclabilité de l’emballage au global.
Les emballages non détectables lors de cette étape de tri sont orientés vers les refus des centres de tri pour une valorisation énergétique.
La solution colorante noire CESA® IR PP 94000721 de Avient Corporation utilisée pour colorer des emballages rigides en PP est une alternative aux solutions colorantes non détectables.
https://www.avient.com/sites/default/files/2024-05/4b - Governance and Corporate Responsibility Committee Charter.Feb_. 2024.v1.1.Final_.pdf
• Evaluate the independence of each non-employee director and recommend to the Board whether each non-employee director is independent. • Evaluate and recommend to the Board the appointment of the Lead Director, as applicable. • Oversee the Board and Committee evaluation process.
Evaluate Resignations of Directors. • Review the continued appropriateness of Board membership of non-employee directors who significantly change their principal business or professional responsibility outside of the Company and submit a conditional letter of resignation to the Board and determine whether the resignation will be accepted. • Consider the resignation of an incumbent director who receives a greater number of votes “withheld” from his or her election than votes “for” his or her election in an election of directors that is not a contested election and recommend to the Board whether to accept or reject it, as provided in the Company’s Corporate Governance Guidelines.
https://www.avient.com/sites/default/files/2020-11/cotrep-at-20-16-avient-corporation-cesar-ir-pe-94000817.pdf
L’avis porte sur la détectabilité et la triabilité de la solution colorante et non sur la recyclabilité de l’emballage au global.
Les emballages non détectables lors de cette étape de tri sont orientés vers les refus des centres de tri pour une valorisation énergétique.
La solution colorante noire CESA® IR PE 94000817 de Avient Corporation utilisée pour colorer des emballages rigides en PE est une alternative aux solutions colorantes non détectables.
https://www.avient.com/sites/default/files/2025-04/Governance and Corporate Responsibility Charter March 2025 Final and Approved.pdf
Evaluate the independence of each non-employee director and recommend to the Board whether each non-employee director is independent.
Review the continued appropriateness of Board membership of non-employee directors who significantly change their principal business or professional responsibility outside of the Company and submit a conditional letter of resignation to the Board and determine whether the resignation will be accepted.
https://www.avient.com/sites/default/files/2022-05/DOC 1879.pdf
Yes, subject to commercially reasonable notice of request, prior approval and a non-disclosure agreement.
Are adequate steps taken to prevent reoccurrence of non-conformances?
Yes Are customers notified when non-conforming product may have been inadvertently shipped?
https://www.avient.com/sites/default/files/2023-07/Avient_CodeConduct_2023_France.pdf
De même, aucuns fonds, actifs ou passifs, non divulgués ou non enregistrés ne sont autorisés, et aucune entrée fausse ou illégale ne peut être faite dans les archives comptables d’Avient, pour quelque raison que ce soit.
L’utilisation non autorisée ou illégale des actifs de la société est interdite.
N’utilisez pas des informations non publiques importantes dans votre intérêt personnel ; et 2.
https://www.avient.com/resources/safety-data-sheets?page=4104
DNU Geon(TM) MNE30-168-1 NON PHTH
PP FR 8-6 LMS-1000