Moisture And Oxygen Risk in the Medical Device Industry
The majority of medical device packaging
is porous in nature. Some medical devices
require a different layer of defense protecting
against oxygen or moisture ingress. For some
devices the ingress of moisture or oxygen over
the shelf-life of the product can impact the
device performance. Any time a foil barrier
comes into play with a high-risk application,
detection of microleaks is absolutely critical to
assuring the shelf-life of the products.
Drug coated stents. Moisture sensitive
bone cement. Oxygen critical diagnostic kits.
Each application has a significant risk associated
with microleaks impacting product performance
over the shelf-life of the product. Ultimately the
risk associated with package integrity failure is
based on the impact of container system failure.
While non-porous medical device packages often
still require sterility, moisture and oxygen will be
the first environmental contaminants to lead to
product failure. Identifying moisture critical
leaks at the point of manufacture and assuring
proper secondary package transportation
performance are two of the most beneficial steps
one can take to guarantee product performance
and patient safety.