Reducing time to market and total cost of ownership are two critical areas that pharmaceutical manufacturers can focus on heavily to be successful in a market
launch for a new drug. While a tremendous
amount of work goes into the discovery and
manufacturing of new drugs, it is important to
protect those drugs from when they are made to
when they are used by a patient.
One of the key areas that must be considered in
this crucial preservation stage is container closure
integrity. Failure to maintain an integral packaging
system risks danger to the patient, and can thus
affect a number of areas within a company
including revenue generation, equipment efficiency,
Since the publishing of USP <1207>, the
pharmaceutical industry now has a guidance
document that can aid in decision making
in relation to packaging and component
selection, as well as how to monitor for
container closure integrity over the entire product
This guidance chapter can be broken down further
to gain a comprehensive understanding of how to
monitor container closure integrity, and mitigate
drug shortages by effectively preserving products
from end to end with a well manufactured and
assembled package or delivery system.
When breaking it down into manageable
parts, there are six key areas to consider that,
when accounted for effectively, give a thorough
understanding of where the greatest risk to
container closure integrity failures are present.
Those six areas are materials, equipment,
process, environment, people, and measurement.
• Materials: When selecting packaging components
for a drug, it is important to understand the
design and intended fit of those components. In
vial systems, blowback features and inner neck
diameters are two crucial factors that need to be
considered when evaluating proper fit for purpose.
Certain stopper designs work most effectively with
certain vial designs, so it is important to look at
these relationships and select a package system
Six Key Considerations to Ensure
Container Closure Integrity
Understanding where the greatest potential failures exist can help
mitigate drug shortages and reduce avoidable supply chain disruptions.
By Christopher J. Barnes, West Pharmaceutical Services, Inc.