Medical Design Briefs - December 2021 - 8

Sponsored Content
I NS I DE STORY
Intertek Allentown, a member of Intertek's global Total Quality Assurance network, is one of more
than 1,000 laboratories and offices and over 43,800 people in more than 100 countries. The company
delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions
for our customers' operations and supply chains. MDB spoke to Paula McDaniel, PhD, Senior
Scientist and Business Development Director, Intertek Allentown, to find out more about addressing
material failure and prevention.
MDB: Why should your customers
try to understand what went wrong
or what caused their product to fail?
Paula McDaniel, PhD,
Senior Scientist and
Business Development
Director, Intertek
Allentown
Paula McDaniel: Problems are
almost unavoidable given the complexity
of our world today and the
time pressure we all encounter.
Failures can arise from supply chain
issues, manufacturing upsets or unintended
product use in the field.
Sometimes a problem will mysteriously
go away without understanding
the root cause. It is tempting to move
on without investing the time in understanding 'why'. The
potential cost in time, materials and customer confidence can
balloon if failures appear again. Performing a failure analysis
will give you the tools you need to improve raw material qualification,
monitor manufacturing conditions and refine your
customer guidance on product usage.
MDB: When do failures occur and what causes them?
McDaniel: We can see failures occur at every stage in a product's
lifecycle - design, manufacturing, packaging, storage/handling,
and end use of the product. These failures can be caused
by poor selection of raw materials and components during the
design phase, contamination, or compatibility issues during the
manufacturing process, product exposure to improper storage
and handling conditions, as well as improper use of the product
by the end user.
MDB: What is the first step in establishing a root cause?
McDaniel: It usually begins with lots of questions! Our material
scientists and failure analysis experts will dig deep into the conditions
and details surrounding the product's failure point to
identify sources of failure. They will key in on potential variations
in raw materials, processing conditions, chemical exposure,
contaminate sources, and environmental exposures to
compile a comprehensive analytical testing program to pinpoint
the failure source.
MDB: It can be a daunting proposition for a manufacturer to
perform a failure analysis investigation - what role does analytical
chemistry testing play in solving failure problems?
McDaniel: A comprehensive testing program should be part of
every failure analysis investigation. With over 50 analytical
techniques available at Intertek Allentown's site alone, we use
these techniques to pinpoint very specific and sometimes subtle
changes in the product that drive the potential failure. Even
though hundreds of routine test standards are available to
choose from, not all will work for your material, failure mode, or
article size and shape. We evaluate the relevance of a standard
test or develop a tailored approach to address your specific raw
material or finished device. Our tailored testing programs offer
a systematic approach to identifying failure modes specific to
your process. Examples include:
* Identification of imperfections, contamination, or residues
(FTIR, Raman Spectroscopy, SEM-EDS)
* Root cause crack formation and discoloration (exposure) in
devices or casings (Optical Microscopy, SEM, FTIR, GPC)
* Evaluation of volatile organic compound loss in association
with temperature and time to mimic process or manufacturing
conditions (TD-GCMS, TGA-IR)
* Correlate multilayer flexible packaging film chemical structure
to oxygen and water vapor transmission properties
(Confocal Raman, Permeation - WVTR/OTR)
* Determining heat seal failures or adhesion issues by understanding
surface contamination, roughness, or layer thickness
(XPS, Optical Profilometry, SEM/Light Microscopy)
* Evaluation of root cause differences in tubing construction -
material differences, processing window, polymer molecular
weight, and performance (DMA, NMR, GPC, DSC)
In addition, a common strategy to pinpoint the root cause is a
comparative analysis - 'good' versus 'bad'. We can look for
differences in chemistry, performance, and physical properties
between the good and bad samples to determine the
cause of the failure. The goal is to combine the context of the
part application or environment with the appropriate analytical
technique to enhance the chances of finding material
differences.
MDB: What if a manufacturer doesn't have a failure yet, but
rather is looking to prevent potential failures? Are there
testing programs/options for failure prevention?
McDaniel: Absolutely! We adapt routine measurement techniques
for novel sample types, as well as develop new methods
for emerging needs to help give our clients peace of mind
throughout their process. Our scientists have decades of
experience supporting client research, development and production
projects, manufacturing, quality control, and consulting.
Our capabilities and solutions help clients enhance discovery,
prototype, scale-up, troubleshooting, and process
monitoring activities.
Visit Intertek Allentown at www.intertek.com/analyticallaboratories/allentown.
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Design Briefs, December 2021

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Medical Design Briefs - December 2021

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