Medical Design Briefs - August 2024 - 7

mately, this advanced level of capability shows a potential client
a commitment to data integrity, testing efficiency, cost awareness,
and a thorough understanding of testing requirements.
Agility and Flexibility
During the ramp up phase, when bringing a program to production
readiness, a significant amount of communication takes
place between client and their CDMO. This communication includes
modifications to testing parameters, acceptance criteria,
and, in rare cases, device specifications. It is imperative that the
CDMO be able to implement these changes quickly and accurately
with minimal vendor involvement. In terms of mechanical
testing systems, these modifications will most often manifest in
the system method (or recipe as it is sometimes called).
Especially when considering autoinjector testing, there are
many different parameters which may be modified, so investing
in a test system with an intuitive and customizable machine interface
will be important. The machine interface should also be
simplistic in its design, ensuring the user can change what they
need but isn't at risk of accidentally changing other parameters.
For full flexibility and agility, the CDMO must have full ownership
of their test methods. They should be capable and empowered
to make the necessary modifications independently of vendor
support. The following interface shows an example of setting
up a functional autoinjector test, with only the necessary callouts
for critical test parameters in industry standard terminology. The
ease of method setup and modification ensures CDMOs can
confidently address dynamically changing requirements.
Speed of Problem Resolution
In any production environment, device failure can mean significant
delays in the batch release and affect the client's confidence
in the CDMO. Any device failure will be treated as mission
critical and result in an extensive root failure cause analysis. Depending
on the data available, this analysis could take weeks or
even months to complete. As such, CDMOs need to invest in
technologies which provide visibility into failures, and integrated
tools to identify issues after they occur. The quicker the analysis
can be performed, or an exception be identified, the shorter the
resulting delay in release and shipment.
Right: Measurement of the injection time and needle depth during the injection of fluid
is a critical piece of data to ensure the device is working as therapeutically intended.
(Credit: Instron)
Left: The Instron Autoinjector Testing System allows for full functionality testing of
autoinjectors, pen injectors, and safety syringes. (Credit: Instron)
Medical Design Briefs, August 2024
Instron's Bluehill Universal software test method for autoinjectors. (Credit: Instron)
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Medical Design Briefs - August 2024

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