Medical Design Briefs - March 2023 - 6

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INSIDE STORY
As medical device companies are innovating new products, close attention needs to be paid
to the creation of safe packaging systems that will protect medical devices during shipment and
transport. Developing an appropriate test plan for package performance testing is of utmost
importance with the globalization of the medical device industry. In addition, packaging systems
need to comply with Food and Drug Administration (FDA) or international health and safety regulations.
To find out more about the expertise required to develop a testing plan for package performance
testing, MDB recently spoke with Sunny Modi, Director of Package Testing for Eurofins
Medical Device Testing in Lancaster, PA.
MDB: What are the expectations
from the FDA and the European
Union (EU) countries on medical
device packaging?
Sunny Modi: The Medical Device
Regulations (MDR) for many EU
countries provide general guidance
on how to design, manufacture, and
package medical devices to minimize
the risk posed by contaminants, pathogens, and residues to
patients. In addition, the medical device must remain sterile
and not adversely affected during transport and storage,
and the integrity of the packaging systems must be clearly
evident to the final user. Similarly, the FDA under 21 CFR
Part 820 on labeling and packaging control states, " Each
manufacturer shall ensure that device packaging and shipping
containers are designed and constructed to protect the
device from alteration or damage during the customary conditions
of processing, storage, handling, and distribution "
(21CFR820.130). The FDA expects the manufacturer to prove
the overall integrity and safety of the packaging system. The
packaging system is subject to rigorous validation processes
that include full validation of the packaging process, accelerated
and/or real-time shelf-life testing, package strength
testing via mechanical performance of the packaging materials,
verification of the sterile barrier system, and finally
performance testing via distribution testing.
MDB: What are distribution testing, shipping studies,
transit testing, and packaging simulations?
Modi: These terms are commonly used to describe the
testing of packaging materials, components, and shipping
containers. Furthermore, these tests measure the effectiveness
of the packaging systems and medical devices when
exposed to various real-world conditions and demands, such
as the mechanical and climatic stresses from being filled,
moved, stored, or transported. However, there are multiple
standards (ASTM, ISTA, and ISO) available to test the system
and evaluate the responses of a particular design or material
when exposed to different stresses. According to the ASTM
D4169-16, distribution simulation " provides a uniform basis
for evaluating, in a laboratory setting, the ability of shipping
container(s) to withstand the different distribution environments "
(ASTM D4169). " This is accomplished by subjecting
shipping container(s) to a test plan consisting of different
anticipated mechanical hazards " (ASTM D4169).
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MDB: What tests are included in the most common distribution
simulation?
Modi: The most common series of tests include manual handling,
vehicle stacking, loose load and vehicle vibrations, low
pressure/high altitude testing, and concentrated impacts.
These tests are further defined based on the modes of transportation
that will be used to deliver the medical devices to
their final destination.
MDB: Prior to performing distribution simulation, what
other conditioning should be considered?
Modi: Preconditioning of the samples at multiple environments
will affect the performance characteristics of
the packaging system, as different conditions are likely to
exist between the origin and final destination points. These
climatic changes play a vital role in the durability and performance
of the packaging system during warehousing and
transportation. As the packaging system goes through various
degrees of humidity and temperature cycles, the structural
properties of the material change, leading to potential
material and sterility failures.
MDB: After the distribution simulation is complete, how should
the packaging system and medical device be evaluated?
Modi: At a minimum, a visual inspection of the packaging
system should be completed to look for gross damages to
the shipper, the carton, or the medical device. In addition,
if a sterile environment is needed, then sterility testing on
the medical device or seal integrity testing on the packaging
system should be performed. Seal integrity testing would
include bubble emission, dye penetration, or seal strength
testing. Finally, the functionality of the medical device
should be evaluated by checking for mechanical properties,
or verifying the device operates as listed in the Instructions
for Use (IFU).
To learn more about Eurofins Medical Device Testing,
visit www.eurofins.com/medical-device.
www.medicaldesignbriefs.com
Medical Design Briefs, March 2023
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Medical Design Briefs - March 2023

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