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/sites/default/files/2024-07/Versaflex TPE for Orthopedic Sole Insert - Application Snapshot.pdf
O RT H O P E D I C PA RT S
M A N U FAC T U R E R
O R T H O P E D I C S O L E I N S E R T
• A super soft TPE (
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified
manufacturing 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
• Available as concentrates or ready-to-use
formulations in a wide range of polymers
• Functionality and color can be combined in
one product for convenience
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
• Documentation support for approval or
transition to comply with (new) regulations
such as IVDR
APPLICATION BULLETIN
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Tossiat_AVIENT LUX-2022-Décret 2021-461 Certificate.pdf
https://www.avient.com/sites/default/files/2021-11/polyone-belgium-name-change-notarial-certificate-nov-8-2021.pdf
https://www.avient.com/sites/default/files/2021-09/avient-uk-finance-name-change-certificate-sep-13-2021.pdf
https://www.avient.com/sites/default/files/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
L A B O R ATO RY E Q U I P M E N T
M A N U FA C T U R E R
P C R W E L L P L A T E S
• Very high level of TiO2 to prevent “cross-talk” between the wells
during the qPCR fluorescence testing procedure
• Minimized background phosphorescence caused by
agglomeration of TiO2 and/or oxidized (stressed) polystyrene
• Preservation of polystyrene grade properties
• Change control of formulation and manufacturing process
• Robust product quality from batch to batch
• Developed optimally dispersed, ready-to-use
white formulation that maintains adequate signal
transmission, as well as minimizing “cross-talk”
and background phosphorescence
• Optimized the use of general purpose polystyrene
(GPPS) for a good balance between melt flow
and other physical properties, such as stiffness
• Provided comprehensive change control of raw
materials and formulation, with a robust
manufacturing process and quality control under
a third party ISO 13485:2016 certified QMS
Mevopur Healthcare Colorants and Formulations
– pre-colored solution
WHY AVIENT?
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
ISO 10993 & USP Class VI compliant solutions
https://www.avient.com/sites/default/files/resources/US_Elk%2520Grove_RCMS%25202013.pdf
WITH ADDITIONAL FACILITIES LISTED ON THE ATTACHED ANNEX)
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
RCMS®:2013 (Option 2)
The Environment, Health, Safety and Security Management System is applicable to:
Design and Manufacture of Colorants for Plastics
Certificate No: 55324
Effective Date 21 December 2017
ABS Quality Evaluations, Inc. 16855 Northchase Drive, Houston, TX 77060, U.S.A.
https://www.avient.com/sites/default/files/2020-12/stat-tech-fire-alarm-case-study-brief.pdf
DONGGUAN
FYRNETICS
F I R E A L A R M C O M P O N E N T S
• Excellent conductive performance, EMI shielding
• Excellent IR absorption
• Quality stability
• Formulated material to meet all customer’s
CTQs and support sensor’s certification for
sensitivity and accuracy
• Provided shorter lead time than previous
material supplier, plus excellent service to
support material change
• Tested surface resistivity using ASTM D257
method, achieving result of E3-E4
Stat-Tech™ ST7400-8010 ESD Formulations
KEY REQUIREMENTS
WHY AVIENT?