Why Medical Device
Packaging Fail ?
Medical device packaging plays vital role in safety and
quality of Medical Devices. The products have to remain
sterile throughout storage, handling and transportation.
Companies that package and ship medical devices are
responsible for the health and safety of patients.
Following are some of the common mistakes which result
in the failure of Medical Devices:
1. Losing sterile integrity
Most common defect in medical packaging , can happen
from fractured thermoforms along with pinholes, slits,
cuts, and tears in pouch packages, defects come from
.caused by dropping.
2. Cutting too many corners
Many people in medical device manufacturing unaware of
the need to test their packaging as per regulatory
requirements, Don’t validate properly, they unknowingly
risk letting suspect devices reach patients.
3. Not prequalifying package and product for
A common mistake , skips the preliminary evaluation,
increasing overall validation costs because some part of
the package fails. That means retests.
4. Ignoring the worst-case scenario
Need to decide the most common shipping configuration
before validating the package.
Before working on a validation, write a protocol. It
provides a blueprint for how testing will be done,
including its purpose, scope, responsibilities,
parameters, production equipment and settings, and
acceptance test criteria. Validation qualifies the
materials and processes that make the complete package.
If one process is not right, the entire system breaks
down and the manufacturer risks harm to patients.
5. Having the wrong sample size
Most common mistake is choosing a sample size that is
too small and that renders results with no statistical
significance. Determining the right sample size for
testing can be challenging. Many factors play a role in
determining sample size including what type of test it
is (e.g. quantitative/variables or
qualitative/attributes); what is the sample population;
how many samples are available for testing; what are the
economics; and what are the risk factors (e.g.
6. Using the wrong package type/material
Using the wrong package type or material for the product
is a package-product compatibility issue, which could
have been avoided if pre-qualification of the packaging
had been done at an early stage.
7. Squeezing oversized pouches into cartons
Pinhole defects in pouches can be reduced by inserting
the pouch into a carton without folding, wrinkling or
creasing the ends.
8. Not recognizing Tyvek® separation as a
One phenomenon that was discovered some years ago, but
only really came to light when medical device packages
began to be integrity tested routinely using bubble and
dye-leak methods, was ‘sheet separation’ of the porous
web of Tyvek®. In integrity tests, this ‘sheet
separation’ appears as false-positive when the material
is bent, folded, or wrinkled.
9. Performing accelerated aging at high test
In ill-conceived attempts to reduce costs and time, some
manufacturers decide to accelerate the shelf life or
expiration date studies to unrealistic and indefensible
limits, usually by raising the test temperature to a
level that causes packages to melt down, warp, or change
in other uncharacteristic behaviors. In addition,
temperatures over 65°C are indefensible based on the
rationale typically used to justify accelerated aging
protocols.Temperature selection for the accelerated
aging study should avoid unrealistic failure conditions,
such as deformation due to melting. This advice is
sometimes ignored in the haste to bring products to