https://www.avient.com/news/unlocking-sustainability-avient-showcase-solutions-circular-economy-chinaplas-2021
Avient will also exhibit its robust portfolio of healthcare materials, including:
• Distribution offerings including PP, PC and TPVs for medical labware, diagnostic kits, and diagnostic devices
• Customized high temperature materials for medical and/or food contact applications which meet ISO10993 biocompatibility and FDA requirements
• Low-retention additives and electrically conductive formulations for pipette tips
https://www.avient.com/news/avient-s-singapore-production-facility-receives-iscc-plus-certification-bio-derived-materials
This certification, in conjunction with the facility’s existing ISO 22000-certified Food Safety Management System and ISO 13485-certified Quality Management System for medical devices, also positions the Chin Bee site to meet stringent hygiene and regulatory requirements for products for mothers and children, food-contact packaging, and the medical and pharmaceutical industries.
https://www.avient.com/resource-center?document_type=59&document_subtype=216
Recent developments of medium barrier, high barrier and super high barrier TPEs and their applications in food and medical packaging
How TPEs Can Help Medical and Pharmaceutical Manufacturers Meet Growing Global Demand
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
Mevopur™ Healthcare Functional Additives
Nucleating Agents
Colors are used in the medical industry for
brand recognition, the coding of different
pharmaceuticals, or visual appeal.
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.
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/2022-06/Malmoe 308840_en_13485_22.pdf
Avient Colorants Sweden AB
Järnyxegatan 7
Box 9053
200 39 Malmö
Sweden
Scope
Avient CAI
Design and manufacture of colour and additive
concentrates and specialty compounds for
the Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 37081 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
Mevopur color and performance concentrates as
well as ready-to-use formulations add value to a
wide range of applications:
MEDICAL DEVICES
• Drug delivery
• Catheters
• Renal care/dialysis
• Surgical instruments
• Dental instruments
• Medical device packaging
• Electronic instruments and accessories
for monitoring
PHARMACEUTICAL PACKAGING
• Vials, ampoules
• Bottles for pills, liquid medicines
• Blister packaging
IN VITRO DIAGNOSTICS (IVD)
• Blood analysis
• IVD devices
• IVD disposables (e.g., pipette tips)
• Point-of-Care
To meet various manufacturing processes,
colorants and functional additives are provided
as concentrates for dilution into the polymer or
as ready-to-use formulations.
Mevopur products
cover the wide range of polymers and thermoplastic
elastomers (TPEs) used in the medical and
pharmaceutical sectors.
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/2020-08/trilliant-case-study-1.pdf
MANUFACTURER BOOSTS
DISINFECTANT RESISTANCE
FOR MEDICAL DEVICE
HOUSINGS
HIGH PERFORMANCE MEDICAL FORMULATIONS
© 2020, All Rights Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
To learn more about Trilliant HC, contact Avient
at +1.844.4AVIENT (1.844.428.4368).
Here’s a case in point: A leading manufacturer of
medical devices in North America had established
a great brand with excellent quality, but wanted
to improve the resistance of its PC/ABS equipment
housings to this new disinfection protocol.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China
has been assessed and certified as meeting the requirements of
麟 ISO 13485:2016
EN ISO 13485:2016
’骥鑫馨瓤) For the foiowing actratEes
Design and manufacture of medical grade thermoplastic elastomers
for non-active medical devices and active medical devices
遴;舞蒸;撇蒸 (non-implantable)
:护、::于 b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/resources/safety-data-sheets?page=4409
MEDICAL ORANGE PE
MEDICAL GREEN PE
https://www.avient.com/resource-center?document_type=59&document_subtype=117
Disinfectant Resistance for Medical Device Housings - Case Study
Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations