Medical Design Briefs: 2021 Technology Leaders - 43

TECHNOLOGY LEADERS Materials/Coatings/Adhesives
Impact Modified Acrylic Copolymers:
Understanding Chemical Resistance
D
esigning medical polymers
for chemical resistance
requires increased
regulation in order to
comply with frequent and robust
disinfection routines in healthcare.1,2
Resin manufacturers
offer high-performance, thermoengineering
polymer blends as
potential solutions with a multitude
of functional properties.
It is pertinent that resin suppliers
provide compelling evidence
outlining chemical resistance
against harsh disinfectants,
aggressive carrier solv ents
for administering oncology
drugs, and biocompatibility to
circulating blood contact with
low to no platelet adhesion and
aggregation.3-6
misleading the designers and
industry.
Part 1 of this two-part series
presents an overview of CYROLITE®
IV/Lab
Filter Housings
Needle/Catheter Hubs
Evidence to support chemical
resistance reflects the analytical
testing performed, which varies.
This often presents a challenging
proposition for medical
device manufacturers that must
discern which offerings can be
used in their anticipated application.
A major source of discrepancy
arises from the unregulated,
discretionary differences
in testing methods introduced
through manufacturer practices.
Although tests are performed in accordance
with standardized institutions,
namely the American Society for Testing
and Materials (ASTM) and the International
Organization for Standardization
(ISO), resin manufacturers may still
use their discretion for parameters driven
by product end-use application.
The industry suppliers present data
based on different methods and properties
that make it challenging to compare
across numerous material choices. For
instance, mechanical testing for property
retention is reported as tensile or
impact or flexural compression, corresponding
to the most suitable strain that a
material can withstand. Subsequently,
random selection of different chemical
acrylic-based medical
copolymers, which are designed
through extensive R&D to carefully
balance properties and performance
for healthcare applications.
More importantly, this
article emphasizes the key role
of polymer mechanical behavior
in governing its chemical resistance
and delivers an understanding
of the chemical attack,
specifically environmental stress
cracking. Part 2 will showcase
the key parameters for evaluating
chemical resistance and
understanding industry-wide
testing discrepancies and will
identify opportunities for unifying
and defining a regulated
approach for material evaluation.
A case study on chemical
resistance testing of CYROLITE®
Medical
Packaging
Respiratory
Fig. 1 - CYROLITE® with balanced optical transmission and mechanical
robustness offers chemical resistance to IPA, lipids, blood, disinfectants,
and oncology drugs, necessary for infusion therapy and other medical
applications such as luer locks, connectors, filter housings, and infusion
therapy applications.
agents for exposure, or exposure environment
as in " wipe " or " immersion " of
the test assembly in chemical agent, or
the duration of exposure ranging from
30 minutes to 24 hours or longer where
the material retains most of the original
mechanical property. More importantly,
often material comparisons for property
and performance are published to showcase
a material's competitive advantage.
Polymethyl methacrylate (PMMA) is
routinely used as a reference material
compromising the extensive R&D evolution
of impact-modified acrylic copolymers
designed for superior properties
and performance. Such an unregulated
approach to test metrics to screen the
different resin material choices could be
Medical Design Briefs 2021 Technology Leaders
www.medicaldesignbriefs.com
acrylic-based medical
copolymers will be presented
following these key considerations
against various chemical
agents.3,7
Roehm America's impactmodified
acrylic copolymers are
formulated to provide a unique
combination of transparency with outstanding
UV transmittance, structural
resilience, high-volume manufacturability,
excellent flow, and moldability into
thin-walled components used in infusion
therapy applications. Additionally,
CYROLITE®
can be reliably sterilized
using gamma irradiation, e-beam irradiation,
and ethylene oxide and offers
resistance to medical fluids such as
lipids and disinfectants for infusion
therapy applications. Furthermore,
these products are bisphenol A (BPA)free,
phthalate free, and compliant with
USP Class VI and ISO-10993-1 and
REACH. These molding compounds
are safe to use in medical devices, such
as medical filter housings, blood separa43
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