https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
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Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2022-05/Glucose Monitoring App Snapshot.pdf
Glucose Monitoring App Snapshot draft
MEDICAL DEVICE OEM
C O N T I N U O U S G L U C O S E
M O N I T O R I N G S Y S T E M
• Adapt to strict processing requirements of a secondary
operation put in place to manufacture a new device model
• Meet material size and thickness requirements while
achieving desired color target
• Overcome material unpredictability and sensitivity to heat,
light and moisture
• Minimize impact of supply chain instability and changes
• Offered support for processing under low
pressure conditions and at every stage of
manufacturing
• Performed extensive R&D work to
consistently deliver the customer’s color
target of a hard-to-achieve light gray
• Effectively addressed all material challenges
and sensitivities
• Provided regular ‘summaries of
understanding’ to keep up with changing
forecasts and ordering patterns
Mevopur™ Pre-color Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB
MANUFACTURER
N E E D L E H U B C O L O R S
• RAL and Pantone® colors available in palette to align with
ISO 6009 color standard
• Opaque and transparent polypropylene selections
available in both masterbatch and ready-to-use precolors
• Raw materials pre-tested to ISO 10993 and USP Class VI
medical device guidelines
• Certified formulations available globally
• Provided RAL and Pantone colors as
required
• Developed custom polypropylene
formulations to meet specific opacities
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the value chain
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Colors
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-09/54139-Certificate-29AUG2022%5B98%5D.pdf
COMPOUND, SUPPLY AND PROTOTYPING SERVICES OF THERMOPLASTICS FOR THE MEDICAL DEVICE
INDUSTRY
Certificate Of Conformance
https://www.avient.com/sites/default/files/2023-09/65567-Certificate-08SEP2023.pdf
MANUFACTURE OF COLORANTS FOR PLASTICS FOR THE MEDICAL DEVICE INDUSTRY
Certificate Of Conformance
https://www.avient.com/sites/default/files/resources/NEU%2520ISO%25209001-2015%2520Exp%25201-22%2520%25281%2529.pdf
COMPOUND AND SUPPLY OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY.
https://www.avient.com/sites/default/files/2023-06/Trilliant HC-auto-injector-snapshot.pdf
MEDICAL CONTRACT
MANUFACTURER
A U T O - I N J E C T O R H O U S I N G
• Excellent chemical and wear resistance
• Excellent impact resistance
• Specific color matching based on customer’s needs
• Outstanding durability to extend product life
• Customized a chemically resistant formulation
to offer an impact-modified alternative to
traditional competitors in the market
• Provided technical support for material
selection, part & tool design, and process
development to accelerate commercialization
• Delivered custom color matching to meet all
key requirements
Custom Trilliant™ HC Healthcare Thermoplastic
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-07/Versollan OM- Len Compartment -Application Snapshot.pdf
AVIENT SOLUTION
MEDICAL DEVICE
MANUFACTURER
C O M P A R T M E N T C O V E R
• Improve grip with a matte rubber finish
• Comply with RoHS Directive
• Provide superior adhesion to PC/ABS
• Achieved excellent adhesion to PC/ABS at a
lower wall thickness of to 2mm
• Improved aesthetics and usability with the
rubber finish provided by our custom
formulation
• Provided quick responses to customer queries
and accelerated time to market
KEY REQUIREMENTS
GOOD ADHESION + COMPLIANCE
LEARN MORE
Versollan™ Thermoplastic Elastomers
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET
MANUFACTURER
S E A L I N G R I N G
• Compliance with strict regulations for medical materials
• Excellent sealing performance
• Good compression set
• Provided a recycled TPE solutions
compared to silicone without increasing
system cost
• Delivered a TPE that complied with ISO
10993-4 & -5 and USP Class VI
• Supported a change to an injection molded
material to ease production and enhance
assembly capabilities
Versaflex™ HC TPEs – OM1040-1 Grade
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-11/Versaflex HC -Syringe tip cap-Case study snapshot.pdf
PRE-FILLED
SYRINGE COMPANY
S Y R I N G E T I P C A P
• Excellent sealing performance
• No DEHP or natural rubber latex added during processing
• Can be sterilized by EtO
• Compliant with ISO 10993-4&5 and USP Class VI
• Formulated a solution that met rigorous
medical application requirements
• Leveraged global footprint to ensure supply
continuity
• Increased process efficiency by replacing
previous thermoset material with a TPE
Versaflex™ HC Thermoplastic Elastomers
KEY REQUIREMENTS
WHY AVIENT?