Medical Design Briefs - August 2024 - 8

Intelligent Testing Capabilities
The more EPRs a device includes, the greater opportunity
there is for something to go wrong in the data collection.
Autoinjectors are inherently complex devices with many different
modes of failure. Because failure can come from the
powerpack, fill volume, primary container, or one of many
other components, simply reviewing the data produced by
the system is in most situations not sufficient to understand
how or why something was out of specification. Qualitative
assessments are required to appropriately identify the
root cause.
Autoinjector testing systems should be equipped with visual
aids to capture the injection event and allow quality engineers
to review the information. Injections are not uniform processes
and have many different variables that can affect the measurement
of EPRs. Video footage can be utilized to capture
unexpected failures such as a needle protruding at an excessive
angle causing the fluid to miss the collection beaker and
result in abnormally low delivered volume. Needle depth can
be incorrectly measured if there is a lingering drop of fluid on
the needle tip. Capturing images and video during testing, to
be used at the time of analysis, can support quickly finding
these root causes.
The software should also offer built-in safeguards to ensure
all modifications are tracked in a traceable audit log and with
the necessary security to delineate who in the organization can
make the changes. Especially in the beginning of a program, as
operators are being onboarded, the security permissions can
ensure that the methods are revision controlled and that the
operator will only have access to the most recent version. Providing
the program and quality managers with the necessary
software tools to oversee and audit their method development
will ensure all client requests are addressed and implemented.
Conclusion
While mechanical testing may play a small role in the total
scope of CDMO competencies, a poorly equipped solution can
result in significant issues with time management, data integrity,
and root cause analysis. Investing in highly capable testing
systems should be considered a long-term investment and serve
to showcase a commitment to quality for potential clients.
Quality teams should emphasize the importance of systems
which enable efficient root cause analysis, and project managers
should actively seek systems built around intuitive user interfaces
to maximize flexibility. The decision-making process
around mechanical testing systems should demand a comprehensive
assessment of their larger impact on meeting client
needs and reflecting the drive for organizational success.
This article was written by Landon Goldfarb, Biomedical
Marketing Manager at Instron, Norwood. MA. For more information,
visit www.instron.com.
Watch the video to see Instron's latest generation Autoinjector Testing System. Developed in close partnership with pharmaceutical device manufacturers, it can perform
full functionality testing on a wide range of drug delivery devices, such as needle shield and button-activated devices, as well as safety syringes. (Credit: Instron)
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Medical Design Briefs - August 2024

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