There is a lot that happens behind the scenes before a medical device package is ready for use.
One important part of that process is making sure the packaging can continue protecting the
product throughout its intended shelf life.

Our team is currently performing an accelerated aging study as part of a general packaging
validation program. The packaged samples are placed inside a controlled temperature and
humidity chamber, where they are exposed to elevated environmental conditions for a defined
period of time.

In the image above, the chamber is operating at approximately
55°C and 65% relative humidity.
These controlled conditions allow the effects of time to be evaluated more quickly than they
would be under normal storage conditions.

What Is Accelerated Aging?

Accelerated aging is a method used to support shelf-life evaluation by storing packaged
products at an elevated temperature. Increasing the temperature speeds up certain aging
processes, allowing manufacturers to gather useful information without waiting several years
for real-time aging to be completed.

The study does not simply involve placing packages in a heated chamber. The temperature,
humidity, exposure time and sample configuration are defined in a controlled protocol. The
chamber conditions are monitored to make sure the samples receive the intended aging exposure.

Why Packaging Validation Matters

Medical device packaging has an important job. It must protect the device during handling,
transportation and storage, while also maintaining the integrity of the package until the
product is ready to be used.

Accelerated aging helps provide evidence that the packaging system can continue performing as
intended after the simulated aging period. Once aging is complete, the samples may be evaluated
using applicable package tests, such as seal strength, visual inspection, package integrity or
other tests defined within the validation plan.

A Controlled and Documented Process

Validation work depends on consistency and documentation. Chamber settings, exposure time,
sample identification and test results must all be recorded carefully. This helps ensure the
study can be reviewed and that the final conclusions are supported by objective evidence.

Accelerated aging is only one part of the overall packaging validation process, but it provides
valuable information about how packaging may perform over its intended shelf life.

Our Commitment to Quality

At InSitu Technologies, quality is considered throughout the product lifecycle. From design and
manufacturing to packaging and validation, each step contributes to the safety, reliability and
performance of the final product.

Studies like this may not always be visible to the end user, but they are an important part of
the work carried out every day to support dependable medical device packaging.