How to Extend Your Medical Device Packaging Expiration Date by Two Years or More Through Validation Testing

Every sterile medical device package comes with an expiration date — not just for the product, but for the validated shelf life of its sterile barrier system (SBS). As that two-year mark approaches, many manufacturers assume they must start the entire validation process from scratch.

Fortunately, that’s not always necessary.

Through revalidation, you can often extend your existing packaging validation — and therefore your labeled expiration date — by up to two years or more, provided your packaging system, sealing process, and sterilization method remain unchanged.

“Many manufacturers don’t realize their packaging validation doesn’t have to expire,” says Alan Evans, Packaging & Validation Manager at LSO. “If the system hasn’t changed, revalidation can extend your expiration date and maintain full compliance — saving significant time and cost.”

What Determines Your Expiration Date

Your expiration date is defined by how long the package can maintain sterility and integrity under real-world conditions.
This is established during initial validation using aging studies (accelerated and/or real-time) that simulate the effects of time and environmental exposure.

When you approach the end of that validated shelf life, you can generate new data — using the same standards and test methods — to confirm continued performance and safely extend the shelf life.

How Revalidation Extends Shelf Life

Revalidation leverages your existing data, supplementing it with targeted testing.
The process typically includes:

1. Review of Original Validation Data

2. Accelerated Aging Study Extension (per ASTM F1980)

3. Package Integrity & Seal Strength Testing (ASTM F88, F1929, F2096)

4. Documentation & Regulatory Justification

If results meet all acceptance criteria, the data can support extending your labeled expiration date without a full revalidation cycle — saving time, money, and regulatory complexity.