https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
https://www.avient.com/resources/safety-data-sheets?page=6736
PMS 214C (CAP) - HC - 7552
TRL ORANGE 172C PP
ET6000-0006 HI UV Lifted Lime NM 1
https://www.avient.com/resources/safety-data-sheets?page=6290
TARGET GOLD - HC-7115
PP GREEN ARMY COT 5815C 2
LIME 3955C NYLON
https://www.avient.com/resources/safety-data-sheets?page=5481
70367 TFX EPIC LIME SHOCK
STAN-TONE HC PLUS- 7C GRAY
PP FR 8-6 LMS-1000
https://www.avient.com/news/alliqua-biomedical-relies-polyone’s-resilience-hc-housings-stand-disinfectants
Homepage
//
News Center
//
Alliqua BioMedical Relies on PolyOne’s Resilience™ HC for Housings That Stand Up to Disinfectants
After extensive material evaluation, the UltraMIST R&D team identified Resilience HC from PolyOne as a potential solution for their new device.
Photo Caption: Resilience™ HC is among the many solutions being displayed in the PolyOne booth at MD&M West 2017.
https://www.avient.com/sites/default/files/2021-08/trilliant-surgical-stapler-housing-case-study-one-pager.pdf
HEALTHCARE
DEVICE OEM
S U R G I C A L S T A P L E R
H O U S I N G
• Easy-to-mold, durable, and good aesthetics
• Excellent disinfection performance and good chemical
resistance
• Compatible with high- and low-temperature sterilization
• Delivered durable and aesthetically pleasing
specialty polymer with the added benefit of
processing flexibility without retooling
• Passed physical, chemical and disinfection
tests in different testing conditions which
proved good tensile strength and chemical
resistance
• Achieved consistent molding shape and
properties
Trilliant™ HC Thermoplastics
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/engineered-polymer-formulations/chemical-corrosion-resistant-formulations/trilliant-hc-healthcare-thermoplastics
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
MEDICAL DEVICE
MANUFACTURER
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
Slide 1: MEDICAL Device manufacturer
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS
MANUFACTURER
C O V I D - 1 9 C O N T A I N M E N T
T U B E S C R E W C A P S
• Wide range of durometers with consistent raw materials
• Processing consistencies across the durometer ranges for
an easy transition between materials
• Materials formulated without animal derivatives at a
competitive cost
• Offered a comprehensive range of solutions
to accommodate specific application
demands such as barrier, flexibility, and
sealing performance
• Provided materials manufactured in an ISO
13485 certified facility
• Delivered a series of medical-grade TPEs
that could be extruded and injection molded
Versaflex™ HC 3810 Thermoplastic
Elastomers
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
Available
in opaque or transparent form based on PP resins,
either as a concentrate or pre-colored formulation,
the colors are standardized to RAL and Pantone
color systems.
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified 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
• Color can be combined with additives to
enhance performance and protection
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 Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
Healthcare use limitations apply—see below.
https://www.avient.com/resources/safety-data-sheets?page=3141
PP GREEN 617 II
GEON HC XV3920 TRANS 9000
TPE 2291C LIME