Medical Design Briefs - May 2021 - 19

TECHNOLOGY LEADERS Materials/Coatings/Adhesives

Impact Modified Acrylic Copolymers:
Understanding Chemical Resistance

D

esigning medical polymisleading the designers and
mers for chemical resistindustry.
ance requires increased
Part 1 of this two-part series
regulation in order to
presents an overview of CYROcomply with frequent and robust
LITE® acrylic-based medical
copolymers, which are designed
disinfection routines in healththrough extensive R&D to carecare.1,2 Resin manufacturers
offer high-performance, thermofully balance properties and perengineering polymer blends as
formance for healthcare applipotential solutions with a multications. More importantly, this
tude of functional properties.
article emphasizes the key role
It is pertinent that resin supof polymer mechanical behavior
pliers provide compelling eviin governing its chemical resistIV/Lab Filter Housings
Needle/Catheter Hubs
dence outlining chemical resistance and delivers an underance against harsh disinfecstanding of the chemical attack,
tants, aggressive carrier solvents
specifically environmental stress
for administering oncology
cracking. Part 2 will showcase
drugs, and biocompatibility to
the key parameters for evaluatcirculating blood contact with
ing chemical resistance and
low to no platelet adhesion and
understanding industry-wide
aggregation.3-6
testing discrepancies and will
Evidence to support chemical
identify opportunities for unifyresistance reflects the analytical
ing and defining a regulated
testing performed, which varies.
approach for material evaluaThis often presents a challengtion. A case study on chemical
ing proposition for medical
resistance testing of CYROdevice manufacturers that must
LITE® acrylic-based medical
copolymers will be presented
discern which offerings can be
Medical Packaging
Respiratory
following these key consideraused in their anticipated application. A major source of dis- Fig. 1.- CYROLITE® with balanced optical transmission and mechanical tions against various chemical
crepancy arises from the unregu- robustness offers chemical resistance to IPA, lipids, blood, disinfectants, agents.3,7
and oncology drugs, necessary for infusion therapy and other medical
Roehm America's impactlated, discretionary differences applications such as luer locks, connectors, filter housings, and infusion
modified acrylic copolymers are
in testing methods introduced therapy applications.
formulated to provide a unique
through manufacturer practices.
combination of transparency with outAlthough tests are performed in accoragents for exposure, or exposure envistanding UV transmittance, structural
dance with standardized institutions,
ronment as in " wipe " or " immersion " of
resilience, high-volume manufacturabilnamely the American Society for Testing
the test assembly in chemical agent, or
ity, excellent flow, and moldability into
and Materials (ASTM) and the Interthe duration of exposure ranging from
thin-walled components used in infunational Organization for Standardiza30 minutes to 24 hours or longer where
sion therapy applications. Additionally,
tion (ISO), resin manufacturers may still
the material retains most of the original
CYROLITE® can be reliably sterilized
use their discretion for parameters drivmechanical property. More importantly,
using gamma irradiation, e-beam irradien by product end-use application.
often material comparisons for property
ation, and ethylene oxide and offers
The industry suppliers present data
and performance are published to showresistance to medical fluids such as
based on different methods and propercase a material's competitive advantage.
lipids and disinfectants for infusion
ties that make it challenging to compare
Polymethyl methacrylate (PMMA) is
therapy applications. Furthermore,
across numerous material choices. For
routinely used as a reference material
these products are bisphenol A (BPA)instance, mechanical testing for propercompromising the extensive R&D evolufree, phthalate free, and compliant with
ty retention is reported as tensile or
tion of impact-modified acrylic copolyUSP Class VI and ISO-10993-1 and
impact or flexural compression, corresponmers designed for superior properties
REACH. These molding compounds
ding to the most suitable strain that a
and performance. Such an unregulated
are safe to use in medical devices, such
material can withstand. Subsequently,
approach to test metrics to screen the
as medical filter housings, blood separarandom selection of different chemical
different resin material choices could be

Medical Design Briefs, May 2021

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