Gross leak, or bubble leak, testing is a core component of a robust package validation strategy. Combined with other methods like dye penetration and seal strength testing, it provides assurance that packages maintain sterility throughout manufacturing, storage, and distribution. 

For medical device manufacturers, packaging shelf life is more than a printed date — it’s a measure of compliance, stability, and product confidence. Most sterile packaging validations establish a two-year shelf life, but that’s often a conservative starting point. With accelerated aging studies, manufacturers can often extend that shelf life to three, four, or even five years — without repeating a full validation.

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

Environmental conditioning matters — but it’s not the whole story. ASTM D4332 is a critical first step in packaging validation, yet standing alone, it leaves gaps that can put your product — and your regulatory timeline — at risk.

Too often, shelf life is treated like a fixed, static number printed on a label—the inevitable result of a formula, test, or aging chamber. But for medical device manufacturers, shelf life is a claim that must be defended.

Learn how a Realistic Worst Case (RWC) configuration impacts your medical package testing and influences regulatory evaluations.

Medical device packaging doesn’t just need to pass sterility and shelf-life validation—it must also survive the rigors of distribution. Transportation testing is critical for proving that your packaging can protect devices from real-world hazards like vibration, drops, compression, and temperature fluctuations. We’ll break down the standard tests used to evaluate packaging performance during transportation, and how they help ensure regulatory compliance.

Life Science Outsourcing (LSO) is excited to announce the release of the updated 2025 edition of our comprehensive white paper, “Medical Device Packaging: Mastery of Design, Sterile Defense, and Compliance.” This revised guide reflects the latest advancements in medical package testing and the growing regulatory landscape surrounding sterile packaging.