# Extend Medical Device Packaging Expiration Date - LSO Validation > Extend your medical device packaging expiration date by 2 years with revalidation testing from LSO. Stay compliant and avoid costly retesting Source: https://lso-inc.com/news/expiration-date/ --- NewsNovember 6, 2025 ![Seal\_Integrity\_600x250](https://lso-inc.com/api/media/file/Seal_Integrity_600x250-3.jpg) 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 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. ### **Why Revalidate with LSO** Life Science Outsourcing (LSO) provides **end-to-end packaging validation and revalidation services** — including accelerated aging, seal strength testing, and regulatory documentation support — all under one roof. Our team ensures your packaging remains compliant with **ISO 11607-1/2**, **FDA 21 CFR part 820**, and **EU MDR** requirements while minimizing disruption to your production schedule. **Don’t let your packaging validation expire.** Talk to an LSO packaging validation specialist today to explore revalidation options that can extend your shelf life — and keep your supply chain running smoothly. ## Related Articles [Jan 29, 2026 ### What the FDA’s QMSR Means for Medical Device OEMs and Manufacturing Partners Read Article](https://lso-inc.com/news/fda-qmsr-what-it-means-for-oems/) [Dec 19, 2025 ### ASTM D4169 Schedule E: Random Vibration Testing Read Article](https://lso-inc.com/news/astm-d4169-schedule-e/) [Dec 19, 2025 ### ASTM D4169 Schedule I: Low Pressure (Vacuum) Testing Read Article](https://lso-inc.com/news/astm-d4169-schedule-i/) ## Ship faster with fewer vendors LSO consolidates assembly, packaging, validation, and sterilization under one roof — FDA-registered, ISO 13485-certified, across three facilities. Tell us about your device and we'll map the fastest path to production. [Request a Quote](https://lso-inc.com/contact/) Or call us directly: [(714) 672-1090](tel:7146721090)