Shelf-Life Extension for Sterile Medical Devices

What is shelf-life extension?

Shelf-life extension is the process used to demonstrate the packaged product can maintain sterile integrity, strength, and functionality for an extended duration after the product’s original defined expiry date with the aim of achieving longer shelf-life.

What are the options when a medical device shelf-life expires?

Manufacturers of medical devices whose labelled shelf-life has expired have a number of options available:

Dispose of the product and manufacture new product
Use the initial shelf-life testing data to repack and re-sterilize the product
If the product has multiple sterile parts separately packed in a kit, replace the part with the lowest shelf-life, repackage the product and relabel
Set up a study on the current aged products to extend the shelf-life

What is the shelf-life extension process for sterile barrier systems?

ISO 11607 requires packaged sterile medical device manufacturers to demonstrate the shelf-life of their packaging system. Manufacturers can extend the expiration date of the device by testing and documenting the evidence in the technical file.

Testing should be carried out using the same tests as had previously been carried out during the original validation when the original shelf-life was established. This should be carried out before the product shelf-life expires.

What needs to be defined in order to extend the shelf-life of a sterile medical device?

Establish the overall number of sterile packaged medical devices that are expiring
Establish the sample size to be assessed through each of the tests (this should be based on previous validation studies or current best practice)
Define the duration that you want to extend the shelf-life for
Establish if new products are going to be used or if the current aged products are available
Define who is going to write the test protocol
Define the requirements in a test protocol
Define the statistical analysis that will be carried out
Define the acceptance criteria for each test
Define the integrity testing required
Define the strength testing required
Define the product testing required
Establish what the requirements for the technical file will include

What product tests may be required to extend the shelf-life of a sterile medical device?

Sterility testing
Functionality testing
Materials testing

How many timepoints should be used when extending shelf-life?

It is recommended that you use multiple, shorter shelf-life timepoints, for example 3 months, 6 months, 9 months to achieve the new shelf-life date. This way you have a backup in the event that your post aging tests do not meet your acceptance criteria for a particular timepoint. You can then revert to the previous successful timepoint and set that as your extended shelf-life.

What package tests are required to extend the shelf-life of a sterile medical device?

Accelerated aging is used to simulate the effects of real-time aging by subjecting samples to elevated temperatures and realistic relative humidity levels for specific periods of time, thereby generating data more quickly and allowing for the extension of the shelf-life.

In parallel with accelerated aging, the manufacturer must also conduct a real-time study in order to validate the data generated during the accelerated aging process.

Product temperature storage labelling considerations:

Where a product is labeled with specific storage temperature range, the upper temperature listed should be used when calculating the accelerated aging duration. This is instead of the normal ambient temperature ( )which is typically 20°C to 25°C. If the labelled range is 15°C to 35°C then the 35°C should be used as the ambient temperature TRT in the calculation.

STERIS offers a range of accelerated aging chambers, which can accommodate both large pallets and single shipping units.

Technical Support

Our technical support team also offers guidance toward:

Packaging evaluations and concept reviews
Test planning and protocol development
Evaluating prior validations and gap analysis

Shelf-Life Extension for Sterile Medical Devices