https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
H Y P O D E R M I C N E E D L E
M A N U FAC T U R E R
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/2021-01/avient-puerto-rico-llc-certificate-of-amendment.pdf
Roman, Secretary of State of the Government of Puerto Rico,
CERTIFY: That on July 13, 2020, at 08:50 AM, "POLYONE PUERTO RICO,
LLC", registry number 365432, performed the following transaction:
Name Change
Previous Actual
POLYONE PUERTO RICO, LLC AVIENT PUERTO RICO, LLC
CERTIFICATE OF AMENDMENT
Government of Puerto Rico
IN WITNESS WHEREOF, the undersigned by virtue
of the authority vested by law, hereby issues this
certificate and affixes the Great Seal of the
Government of Puerto Rico, in the City of San Juan,
Puerto Rico, today, July 13, 2020.
https://www.avient.com/sites/default/files/2022-08/Avient CDP_Climate_Change_Questionnaire_2022.pdf
In addition, Avient has externally
certified EHS&S management systems, including ISO 9001 worldwide.
Additionally, 52% of our
facilities are certified to ISO 14001, 56% to Responsible Care 14001 and ISO 45001, and 10%
of our high energy sites are certified to ISO 50001.
Additionally, 52% of our
facilities are certified to ISO 14001, 56% to Responsible Care 14001 and ISO 45001, and 10%
of our high energy sites are certified to ISO 50001.
https://www.avient.com/sites/default/files/2024-05/Responsible Care_14001 Global Cert_Avient_2024.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/news/avient-features-specialty-healthcare-material-solutions-services-mdm-west-2022
Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.
https://www.avient.com/news/pharmapack-2025-feature-polymer-colorants-and-additives-avient-enhance-performance-and-sustainability
The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”
https://www.avient.com/news/non-pfas-flame-retardant-formulations-expand-avient-s-compl-t-long-fiber-polyketone-portfolio
These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.
https://www.avient.com/company/sustainability/sustainability-report/products/supplier-collaboration-evaluation
Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
https://www.avient.com/news/avient-and-plastic-bank-reuse-ocean-bound-plastic-luxury-caps-and-closures
¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.