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Packaging Testing For Medical Devices
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Divya Ganapathy
Technical Consultant (Medical Device
Regulatory Affairs),
UL India Pvt. Ltd., Bangalore |
Introduction
Medical
Device Packaging is highly regulated and must meet the
standard requirement. Historically devices have been
tested for degradation by accelerated aging and other
various material characteristics. Packaging testing is
measuring the characteristics and property of packing
material. Most precarious factor is the sterility
which should be maintained through the distribution
and storage. Packaging must comply with ISO 11607 and
EN 868-1, in order to satisfy European regulations and
obtain a CE Mark. Testing a new packaging design
before full scale manufacturing can save time and
money. Many manufacture conduct packaging testing
in-house or through third party lab (ISO/IEC 17025
accredited) which is accredited and certified (ISTA
certified, ISO 17025). The testing is vital to ensure
integrity of the package’s seal.
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Medical Device Stability
The
general factors that influence the product stability
are physical, chemical, microbiological and
toxicological. Most of the manufacturer conducts the
testing at different phases of product life cycle like
product design stage, product launch, and new package
design, resolve package damage issue and sometimes
based on client requirement.
Regulations And Standards For Packaging Testing
Packaging testing guidelines are listed in ISO 11607
describing the available ASTM packaging tests. The key
aspects of packaging validation are material
qualification, seal validation process and whole
package seal integrity. Physical tests like burst,
peal, creep and leak tests are performed as per ASTM
standards. ISO 11607 require both accelerated and real
time to be performed simultaneously. The key areas to
be focused in the packaging are stability,
performance, package integrity and strength testing
(Figure 1).
Package Integrity Test
Depending on package design, a variety of package
integrity testing methods may be employed. This is to
ensure the integrity of package seal and system. Visual
inspection, peel strength, burst strength, creeps and
bubble emission test are some of the package integrity
test. During the study conduct deformities break or crack,
blister can be observed (Figure 2).
Figure 2: Deformities from visual inspection
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Figure 3: Burst test (ASTM
F1140)
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Seal strength test is
conducted through a simple burst and / or creep test where
packages are pressurized and evaluated for the rupture
pressure points and time of failure. It is conducted to
measure the ability of package seal to resist separation.
Burst and creep testing entails pressurizing the inside of
the package and measuring the pressure required to either
cause seals to separate or packaging materials to rupture.
Some packages use porous materials, allowing the contents
to be gas sterilized through the porous package walls
after the package has been sealed; burst testing of these
packages can require higher inflow capability in order to
achieve sufficient pressure to challenge the package. |
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Figure 4: Dye
penetration
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Dye penetration test is
conducted to detect the presence of any leakage in the
seal, (Figure 4). This test method is limited to porus
material which can retain the dye penetrant solution and
prevent it from discoloring the seal for 5 seconds. The
study can be conducted through different methods like
injection, edge dip and eye dropper. |
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Bubble
test as per ASTM F2096 standard is conducted by
visually inspecting for bubble streams caused due to
affect in the packaging while it is submerged in
water. This destructive testing provides a practical
way to examine packages for gross leaks, which may
render the product non-sterile. This test may apply to
very large or long packages, which do not fit into any
other package integrity test method apparatus. |
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Figure 5: Bubble Test
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Peel Testing is performed in
accordance with ASTM F88 and EN 868-5 Standard Method for
Seal Strength of Flexible Barrier Materials. The test
results are not only related to package integrity, but
also to measuring the packaging processes’ ability to
produce consistent seals. Given that seal strength is a
necessary requirement for packaging, Peel Tests are
ubiquitous for all types of packaging. |
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