https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
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/2021-07/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/2020-07/case-study-one-pager-versalloy-infusion-adapter-port.pdf
MEDICAL EQUIPMENT
MANUFACTURER
C L O S E D S Y S T E M D R U G
T R A N S F E R D E V I C E
• A new material for a seal inside the next generation of
closed system drug transfer device
• Compliance with stringent regulatory standards:
• Biocompatibility to ISO10993
• USP VI compliance
• Provided regulatory support services and
expertise throughout extensive medical
approval process
• Provided a custom formulation compliant with
the highest healthcare regulatory standards
• Enabled material to be manufactured and
shipped globally
Custom Versalloy™ HC 9220-90 Formulation
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/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RESPIRATORY
DEVICE
MANUFACTURER
C P A P M A C H I N E C O V E R
• Good aesthetics with high COF for grip functionality
• Chemically bondable to FR PC/ABS down to 1mm
• NCS S 9000-N color suitable for UV laser marking to white
• Good scratch and mar resistance
• Good chemical resistance to detergents, alcohols and bleach
• Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017
• Customized formulation to balance mar
resistance, flow, and laser marking
whiteness and clarity
• Collaborated on tooling improvements to
widen processing window and increase
yield rate
• Provided application development and on-
site technical support to manage short
shot, sink marks, burn marks and air trap
Customized VersaflexTM TPEs
WHY AVIENT?
https://www.avient.com/sites/default/files/2022-01/PREPERM - Body Scanner - Application Snapshot.pdf
SECURITY EQUIPMENT
MANUFACTURER
B O D Y S C A N N E R
• Replace PMMA based radome material
• Consistent dielectric performance across large sheet/surface area
(4mm thick, 2m high)
• Ultra low losses
• No defects across full surface area
• High resolution imaging to show small illegal objects
• Formulated a custom material to match customer
requirements
• Reduced dielectric loss to 0.0009
• Improved image quality of body scanner with
uniform dielectric performance and exceptionally
low losses
• Enabled scan time of 2 seconds and person
throughput of 400 persons per hour, compared to
100 person throughput of conventional devices
PREPERM™ PPE 260 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-08/colormatrix-aazure-brochure-1.pdf
It enables:
• Increased rPET content
• Reduced CO2 emissions
When added to PET preforms and bottles,
ColorMatrix AAzure helps to:
• Improve bottle quality
- Reduced preform acetaldehyde
by up to 80%
- Improved mechanical strength
- Lightweighting
• Improve processability
- Reduced bottle blowouts
- Reduced scrap
- Improved productivity
• Reduce energy consumption during
bottle blowing process
ColorMatrix AAzure has a slight blue tint, which is
useful for off-setting yellowing often associated
with the use of rPET, and has minimal impact on
final product color or aesthetics.
IMPROVED BOTTLE
QUALITY
+2% in
neck
+3% in
body
-12% in
base
8.5g 0.5L bottle, 60% rPET
Re-optimization of Polymer
Weight Distribution to Improve
Bottle Strength
Based on commercially produced water
bottles, 51,000bph
Mechanical Strength
Based on PTI 14.4g 0.5L water bottles, Instron testing
To
p
Lo
ad
(l
bs
Burst Pressure
Based on 8.5g, 0.5L commercially produced water bottles
Bu
rs
t P
re
ss
ur
e
(B
ar
REDUCED CO2 EMISSIONS
25% reduction in energy consumed during the bottle blowing process, based
on a commercial process producing 8.5g 0.5L water bottles at 51,000 bph
En
er
gy
k
W
Reduced Energy Consumption
ColorMatrix AAzure increases the heat-up rate for preforms, enabling energy
reductions for the heating lamps used during the bottle blowing process.
https://www.avient.com/sites/default/files/2023-07/Avient_RY 2022 CDP Verification Opinion Declaration_07-24-23%5B30%5D.pdf
Energy:
o Diesel Fuel Consumption: 4,754,671 kWh
o Natural Gas Fuel Consumption: 184,415,668 kWh
o Renewable Energy Consumed - Self Generated (solar): 260,378 kWh
o Renewable Energy Consumed - Self Generated (Wind): 2,554,186 kWh
o Grid Electricity Consumed: 436,400,546 kWh
Page 2
WATER RESOURCES • ENVIRONMENTAL SERVICES • INDUSTRIAL HYGIENE • SAFETY • SUSTAINABILITY
Apex Companies, LLC • (800) 733‐2739 • www.apexcos.com
o Renewable Energy Credits (REC) Purchased: 100,691,000 kWh
o Renewable Electricity Consumed – Offsite: 128,982,866 kWh
Period covered by GHG emissions verification:
January 1, 2022 to December 31, 2022
GHG Reporting Protocols against which verification was conducted:
World Resources Institute (WRI)/World Business Council for Sustainable Development (WBCSD)
Greenhouse Gas Protocol, Corporate Accounting and Reporting Standard, Revised Edition (Scope 1 and 2)
and the GHG Protocol Scope 2 Guidance, an amendment to the GHG Protocol Corporate Standard
WRI/WBCSD Corporate Value Chain (Scope 3) Accounting and Reporting Standard
Verification Protocols used to conduct the verification:
ISO 14064-3 Second Edition 2019-04: Greenhouse gases - Part 3: Specification with guidance for the
verification and validation of greenhouse gas statements
Apex’s standard procedures and guidelines for external Assurance of Sustainability Reports and
International Standard on Assurance Engagements (ISAE) 3000 Revised, Assurance Engagements Other
than Audits or Reviews of Historical Financial Information (effective for assurance reports dated on or after
Dec. 15, 2015), issued by the International Auditing and Assurance Standards Board.