|
About Packaging Failures: The
Largest Source of Sterility Recalls
“Sterility Recalls” is a disturbing
issue within the healthcare industry. “The largest source of
sterility recalls [80% according to some sources] is packaging
failures. Packaging design has to match product complexity.
In the changing landscape of the
healthcare industry, one major change is the increase in more
complex products including:
i) Combination products, such as the
pairing of a delivery device and a pharmaceutical
ii) The growth of kits, and larger
products made up of more items connected together whereby reducing
the amount of manipulation and handling required by healthcare
pros
iii) More microbiologic-centric
products like skin tissues.
More complex products mean
packaging/sterilization pros must consider more complex material
structures, and understand that materials and products are likely
to be more sensitive to sterilization.
Another part of the changing
healthcare landscape is regulatory compliance. Major Factors
Responsible for Packaging Failure Recalls:
-
Lack Of Technical Expertise:
Technical talent require thorough on-the-job training and
expertise.
-
Not Validated Packaging Processes
-
Inappropriate Sealing
-
Supplier Quality Issues
-
Batch Sizes For Testing: Which may
cover the issues such as no. of batches of materials to be used,
sterilization stresses to be placed on packaging, etc.
-
Testing And Packaging Of Product
With The Maximum Stress Exposure
-
It may be useful to test the product
in the package, even though testing just the packaging is a
simpler, less costly process.
Sterility assurance and packaging
professionals need to work together to make sure that the testing
performed will provide a safe and effective package.
(Abstracted from Presentation by
Joyce Hansen, V.P. of sterile process technology, Johnson &
Johnson as reproduced in
http://www.packworld.com/applications/healthcare/greater-productcomplexity-demands-more-healthcare-packaging)
* * * * *
|
