Medical Design Briefs - February 2024 - 62

n IVD Cartridges: Consistent, Repeatable Tests
A market leader in diagnostics developed an in vitro diagnostic
(IVD) system using a self-contained test cartridge. During development,
they experienced two issues that led to testing process
failures: 1) the syringe pump in their cartridge would fail by sticking
at the bottom of the cylinder, and 2) the valve used to control
the pumping of fluids would occasionally fail to actuate. In both
cases, the friction levels in these mechanisms were too high. Our
customer needed to lubricate both the pump and the valve to
improve their cartridge and make their testing process consistent
and repeatable.
The Challenge. To address the issue, the company was looking
for a lubricant to reduce the force required to actuate both
the pump and the valve. Given the location of the lubricant
and the potential for contact with the sample, the lubricant
also needed to be chemically inert to the sample, all cartridge
materials, and testing reagents. The lubricant also needed high
shelf stability to endure the many shipping and storage conditions
associated with decentralized testing in both developed
and developing economies.
The Solution. Working closely with the diagnostic company,
Chemours' technologists and technical team helped the customer
evaluate different Krytox™ lubricants in their application.
Based on the customer's requirements, they offered a few
lubricants that were most likely to succeed, and then worked
with the customer to determine which lubricant performed best
in their application. Subsequently, the customer qualified two
Krytox™ lubricants in their product, helping to ensure security
of supply through their growth phase.
Advantages in Diagnostic Applications. Krytox™ lubricants do
not support microbial growth and are chemically inert to nearly
all test reagents and analytes. These lubricants are compatible
with a wide range of plastics and other cartridge materials and are
thermally and oxidatively stable over long periods of time.
The Outcome. With Krytox™ lubricants in place, the customer's
equipment was able to run consistent, repeatable analysis. In
addition to understanding the customer's challenge, Chemours
technologists and technical team used their experience and expertise
to support the customer in improving their lubricant application
process and building the needed in-house expertise. The
team continues support by ensuring their in-house experience is
sustainable and partnering with them as they uncover other challenges
in their device development.
Solving Diagnostic Equipment Challenges. Reducing and
eliminating process failures is critical to reducing regulatory
risk in the product development cycle and maintaining user
acceptance after commercialization. Although lubricants may
not be the driving factor in diagnostic device design, proper
lubrication is crucial to ensure a consistent, repeatable process.
Chemours' technical service team can help reduce the burden
on our customers' engineers through assistance in selecting
and applying the right lubricant for the customers' application.
They are also available to help with training and troubleshooting
as needed.
When a life is on the line, every second
is crucial, just like every connection.
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62
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Medical Design Briefs, February 2024
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Medical Design Briefs - February 2024

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Medical Design Briefs - February 2024 - Cover Flap
Medical Design Briefs - February 2024 - Cover Flap1A
Medical Design Briefs - February 2024 - Cover1
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