Medical Design Briefs - June 2021 - 12

Acrylic Copolymers
Disinfectants
Control (unexposed
at 1.5% strain)
Formaldehyde
Peracetic acid (PA)
Hydrogen
peroxide (HP)
HP/PA/Acetic acid
Bleach
Glutaraldehyde
Ortho-phthaldehyde
Diethylene glycol
butyl (DEGB) ether
Table 2. ESCR for CYROLITE® Med 2 after 1.5 percent strain and exposure to 10 different disinfectants
for 24 h showing the tensile property retention (percent). Note: For formaldehyde and peracetic
acid, CYROLITE® Med 2 retained 90 percent property retention at 1 percent strain. Property
retention: >90% (green), 80-90% (yellow), <80% (red).
Oncology Drugs
Cisplatin (1.0 mg/ml), Water
Carboplatin (10.0 mg/ml), 10 mg Mannitol, Water
Mitomycin (0.5 mg/ml), 1 mg Mannitol, Water
Gemcitabine (Gemzar) (38.0 mg/ml), Mannitol, Water
Oxaliplatin (2.0 mg/ml), 5% Dextrose, Water
5-Fluorouracyl (50.0 mg/ml), Water, pH 9.2
Epirubicin (Ellence) (2.0 mg/ml), Water, pH 3.0
Propofol (10.0 mg/ml), Soybean Oil, Glycerin, Egg
Phospholipids
Cyclosphosphamide (20.00 mg/ml), 0.9% Benzyl
Alcohol, Water
Ifosfamide (50.0 mg/ml), Additives, Water
Doxorubicin Hydrochloride (2.0 mg/ml), Water, pH 3.0
Paclitaxel (Taxol) (6.0 mg/ml), Castor Oil, Alcohol
Modulus
Strength
Crazing
No
No
No
No
No
No
No
No
No
No
No
No
Table 3. Tensile property retention for CYROLITE® Med 2 after 1.0 percent strain and exposure to
10 oncology drugs for 24 hours. Property retention: >90% (green), 80-90% (yellow), <80% (red).
and the percent change in tensile properties
of each material reported for each
reagent reported. Tensile property re -
tention was measured using an extensometer
at 10 percent based on 50 mm
gage length at a cross head speed of 2
in./min. Tensile strength and modulus
were reported to three significant figures
with standard deviation reported to
two significant figures. Elongation at
yield (percent) and elongation at break
(percent) were reported to two significant
figures (ASTM D6436).
Interestingly, the material shows tensile
property retention 95 percent,
specifically tensile strength, modulus,
and elongation at yield, after exposure
to IPA for 5 hours at all strain levels (see
12
Cov
Table 2). Certainly, the high performance
is a direct function of the composition
and the careful formulation of components
that present a compatibilized
blend. It is essential to understand that
the preconditioning enables sufficient
segmental motion during annealing to
potentially eliminate any residual molding
stresses and offer a homogenous
part with representative properties,
hence yielding a ductile, toughened,
and IPA-resistant material.
Exposure to Disinfectants
This test was conducted using Wet
Patch Method (ASTM D543 - 14). Stan -
dard type 1 ASTM tensile testing specimens
were mounted to strain jigs
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ToC
Modulus Strength
Elongation at Yield
Elongation at Break
Crazing
designed to apply a predetermined
amount of strain onto the specimens. A
saturated cotton patch (such as sterile
gauze) was draped over them such that
test specimen is in direct contact with
the disinfectant reagent being tested.
The length of exposure was 24 hours at
room temperature. Three sets of measurement
data were taken; a set of specimens
(five replicates) under no strain
and no reagent applied, strain and no
reagent, and strain and each disinfectant
reagent.
Table 3 shows the impact of disinfectant
exposure on CYROLITE Med 2 at
1.5 percent strain for 24 hours. The data
shows excellent chemical resistance to 6
of 10 disinfectants tested, with tensile
property retention 95 percent, and no
visual signs of crazing or stress cracking.
For the remaining four agents, the bars
show 75 percent tensile property retention.
The elongation at yield and break
had 90 percent retention for all 10 disinfectants
tested, indicating that the ductility
of the polymer is maintained after
chemical exposure and induced stress.
Exposure to Chemotherapy Drugs
in Carrier Solvents
ASTM type 1 tensile bars were
annealed at material-specific VICAT softening
temperature for ~4 hours. These
were mounted on jigs designed to
induce a 1 percent strain and held for 24
hours. Five test bars were tested per
chemotherapy drug in their carrier solvent
for 13 different drugs by wet patch
method.
Figure 8 shows the impact of chemo -
therapy drugs in their carrier solvents
for CYROLITE Med 2. CYROLITE Med
2 shows excellent tensile property retention,
95 percent after exposure to
chemotherapy drugs while strained at 1
percent for 24 hours. It is imperative to
understand the impact of the carrier solvents
these drugs are administered in;
they can potentially pose a more aggressive
interaction with the polymer material
than the therapeutic drug component
and lead to brittle catastrophic failures.
Conclusion
Ideally, the industry would benefit
from both objective and standardized
metrics to provide an overview of different
product offerings with their respective
pros and cons and performance
thresholds. However, the feasible implication
of these standardized metrics
would require industry-wide harmonizaMedical
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Medical Design Briefs - June 2021

Table of Contents for the Digital Edition of Medical Design Briefs - June 2021

Medical Design Briefs - June 2021 - Intro
Medical Design Briefs - June 2021 - Cov4
Medical Design Briefs - June 2021 - Cov1a
Medical Design Briefs - June 2021 - Cov1b
Medical Design Briefs - June 2021 - Cov1
Medical Design Briefs - June 2021 - Cov2
Medical Design Briefs - June 2021 - 1
Medical Design Briefs - June 2021 - 2
Medical Design Briefs - June 2021 - 3
Medical Design Briefs - June 2021 - 4
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Medical Design Briefs - June 2021 - Cov3
Medical Design Briefs - June 2021 - CovIV
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