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/industries/healthcare/medical-devices-equipment/surgical-medical-instruments
Soft-touch, durable, and colorable TPEs that comply with USP Class VI, ISO 10993, and ISO 9001 for diverse overmolding needs, aesthetics, and haptics
Transcend™ Precolored Gray and White PSU achieved accurate color match to non-polysulfone (PSU) components
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials
Thermoplastic Elastomers for Healthcare Applications
Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications,
Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5.
VERSAFLEX™
HC MEDICAL
TUBING SERIES
• Improve extrusion
rates, achieve high
service temperature
performance or
increase clarity
in medical tubing
• Meet
biopharmaceutical
needs for weldability
and minimize
extractables during
processing
VERSALLOY™
HC SERIES
• Obtain better flow in
long, thin paths and
lower shrink rates
versus typical TPVs
with our alloys, made
with Santoprene™
TPV
• Color easily and
obtain a smooth
tactile feel
VERSAFLEX™
HC GASKETS &
STOPPERS SERIES
• Achieve no coring,
good puncture and
resealability in static
stoppers
• Meet low COF
and low stiction
requirements in
dynamic seals
VERSAFLEX™
CL E SERIES
• Increase clarity and
flexibility in bags,
bottles and films
• Mitigate risk with
plasticizer-free
formulations for
film extrusion
• Deliver excellent
odor & O
2
barrier
performance for
film extrusion
INDUSTRY BULLETIN
TPE HEALTHCARE PRODUCT SELECTOR GUIDE
Versaflex™ HC MT Series
Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔
High clarity,
without plasticizers
Versaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔
Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔
Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature
Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant
Versaflex™ HC Gaskets & Stoppers Series
Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing
Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set
Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction
Versaflex™ CL E Series
Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔
High clarity, without
plasticizers; E95 also offers
excellent odor & O
2
barrier
Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔
Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔
Versaflex™ HC 3810 Series
Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ -
Formulated without
animal derivatives,
excellent colorability,
translucent
Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ -
Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ -
Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ -
Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ -
Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ -
Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ -
Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ -
Versalloy™ HC 9210 Series
Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔
Smooth surface
aesthetics
Versalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔
Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔
Versalloy™ HC 9220 Series
Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔
ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔
Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔
Standard Healthcare Grades
Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength
Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔
High clarity, boilable
Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔
Versaflex™ OM Series
Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC
overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔
Color Hardness Specific Gravity
Compression Set
@ 23°C
Compression Set
@ 100°C
100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength
ISO
10993
USP VI
Special
Characteristics
ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi Mpa ASTM psi Mpa ASTM psi ISO Mpa ASTM % ASTM pll ISO kN/m
GENERAL PROPERTIES TENSILE PROPERTIES OTHER
For further information on specific grades, review technical data sheets.
https://www.avient.com/sites/default/files/2024-11/Stan-Tone HC Plus Product Bulletin_0.pdf
By meeting stringent USP
Class VI biocompatibility standards, Stan-Tone
HC Plus offers pre-tested solutions that speed
up development time, decrease risk, and satisfy
healthcare industry material requirements.
KEY CHARACTERISTICS
• Meets USP Class VI standards
• Biocompatible
• Provides lightfastness, chemical resistance,
and heat stability
• Available in standard single pigment or custom
multi-pigment colors
• LSR and HCR options available
TARGET APPLICATIONS
Stan-Tone HC Plus silicone dispersions are suitable
for a variety of healthcare applications including:
• Catheters and medical tubing
• Medical and surgical equipment
• Labware and diagnostic devices
• Specialty medical devices and wearables
Product
Code
Pigment Type
% Pigment
(approx.)
https://www.avient.com/sites/default/files/2024-11/Stan-Tone HC Plus Product Bulletin.pdf
By meeting stringent USP
Class VI biocompatibility standards, Stan-Tone
HC Plus offers pre-tested solutions that speed
up development time, decrease risk, and satisfy
healthcare industry material requirements.
KEY CHARACTERISTICS
• Meets USP Class VI standards
• Biocompatible
• Provides lightfastness, chemical resistance,
and heat stability
• Available in standard single pigment or custom
multi-pigment colors
• LSR and HCR options available
TARGET APPLICATIONS
Stan-Tone HC Plus silicone dispersions are suitable
for a variety of healthcare applications including:
• Catheters and medical tubing
• Medical and surgical equipment
• Labware and diagnostic devices
• Specialty medical devices and wearables
Product
Code
Pigment Type
% Pigment
(approx.)
https://www.avient.com/sites/default/files/2022-06/Maxxam FR Injection Molding Processing Guide.pdf
Barrel Temperatures
°F (°C) PP
Mineral-Filled
PP
Glass-Filled
PP HDPE LDPE
Rear Zone 360–390(182–200)
400–420
(204–216)
415–435
(213–224)
400–420
(204–216)
370–390
(188–199)
Center Zone 370–400(188–204)
410–430
(210–221)
425–445
(218–229)
410–430
(210–221)
380–400
(193–204)
Front Zone 390–410(200–210)
420–440
(216–227)
435–455
(224–235)
420–440
(216–227)
390–410
(199–210)
Nozzle 400–425(204–219)
415–435
(213–224)
430–450
(221–232)
430–450
(221–232)
400–425
(204–219)
Melt Temperature 400–425(204–219)
415–435
(213–224)
430–450
(221–232)
430–450
(221–232)
400 - 425
(204–219)
Mold Temperature
°F (°C)
60–120
(16–49)
Pack & Hold Pressure 50–75% of injection pressure
Injection Velocity
(in/s) 1.0–3.0
Back Pressure
(psi) 50–100
Screw Speed
(rpm) 30–100
Drying Parameters
Hours @ °F (°C)
Not typically required.
https://www.avient.com/sites/default/files/2020-09/stat-tech-tri-fold-processing-guide.pdf
STARTUP & SHUTDOWN RECOMMENDATIONS
Purge Compound HDPE or HIPS
Recycling
Recycling Stat-Tech up to 20% is permissible.
https://www.avient.com/sites/default/files/2020-12/therma-tech-processing-guide.pdf
Processing Guide 3
Start Up & Shut Down Recommendations
Purge Compound HDPE or HIPS
Recycling
Recycling Therma-Tech™ up to 20% is permissible.
https://www.avient.com/resources/safety-data-sheets?page=6075
BLUE W/2% SHOOTING STAR
BLUE W/4% SHOOTING STAR
UV WHITE ASA