# ISO 11607 Packaging Validation — Sterile Barrier Testing > ISO 11607-compliant packaging validation from protocol design through production release. Seal testing, accelerated aging, and distribution simulation. Source: https://lso-inc.com/solutions/packaging-validation/ --- # ISO 11607 packaging validation that passes audits the first time ISO 11607-compliant packaging from protocol design through production release [Get a Packaging Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [View Testing Standards](https://lso-inc.com/standards/) ![Packaging validation](https://lso-inc.com/api/media/file/Packagingvalidation.webp) FDA-Registered Manufacturing Facility ISO 13485 Certified Quality System 12 Cleanrooms Class 5–8 125,000+ Sq Ft Regulated Manufacturing 3 Facilities CA | NH | Costa Rica ISO 17025 Accredited Packaging Lab Medical device packaging failures are expensive and avoidable — yet they remain one of the most common sources of regulatory delays. Seal failures, aging test surprises, and incomplete protocols push back launches and trigger re-validation cycles that consume months. Most companies don't discover their packaging gaps until an auditor does. ## Full-Scope Packaging Validation ### Pre-Validated Packaging Systems LSO's pre-validated pouch and tray systems can eliminate 6 months from your validation timeline. Start production faster with a packaging system that's already been through seal testing, aging, and distribution simulation — with audit-ready documentation included. ### Protocol Design & Review Custom test protocols aligned to ISO 11607-1, ISO 11607-2, ISO 17025, ASTM, and ISTA — designed by packaging engineers who've validated thousands of sterile barrier systems. ### Seal Strength & Integrity Testing Comprehensive ASTM F88 seal strength, ASTM F1929 dye penetration, and ASTM F2096 bubble leak testing with calibrated equipment and ISO 17025-accredited procedures. ### Accelerated & Real-Time Aging ASTM F1980 accelerated aging and real-time shelf life studies with full ISO 17025 environmental chamber control and documentation. ### Distribution Simulation ASTM D4169 and ISTA 3A transit testing that validates your packaging survives real-world shipping conditions — not just lab conditions. Thousands of sterile barrier systems validated. ISO 11607, ISO 17025, ASTM F1980, ASTM D4169, ISTA — we know what auditors look for because we've seen what fails. ## From Protocol to Production Release 1 ### Protocol Review Review your device, packaging system, and sterilization method. Identify the right test matrix. 2 ### Sample Preparation Prepare test samples, set up aging chambers, and calibrate test equipment. 3 ### Testing Execution Seal strength, integrity, aging, and distribution testing per protocol. 4 ### Report & Documentation Complete test reports with raw data, statistical analysis, and audit-ready summary. 5 ### Submission Support Guidance on how to present packaging validation data in your regulatory submission. ## Does This Sound Familiar? You're weeks from your 510(k) submission and packaging validation hasn't started — or the data you have won't hold up. Seal failures in the field or during testing. Product is on hold and you need answers fast. You're switching packaging materials or suppliers, and the change triggers a full revalidation under ISO 11607. Your accelerated aging study didn't go as planned, and your shelf life claims are in question. An auditor flagged gaps in your packaging validation — incomplete protocols, missing test data, or undocumented changes. ## Related Standards & Testing [Medical Package TestingFull testing capabilities and standards](https://lso-inc.com/medical-package-testing/) [ISO 11607 StandardsPackaging validation standard requirements](https://lso-inc.com/medical-package-testing/standards/iso-11607/) [Pre-Validated PackagingSkip 8–12 weeks with pre-validated systems](https://lso-inc.com/prevalidated-packaging/) [Sterilization & ValidationNext step after packaging — sterilization method validation](https://lso-inc.com/solutions/sterilization-validation/) [OEM PathFor OEMs scaling or consolidating vendors](https://lso-inc.com/start-here/oem/) [Seal Strength vs. Seal IntegrityThe difference between ASTM F88 (strength) and F1929/F2096/F3039 (integrity).](https://lso-inc.com/seal-strength-vs-seal-integrity-testing/) ## Get your packaging validation plan reviewed Tell us about your device, packaging system, and submission timeline. Our packaging engineering team will identify the right tests, scope, and timeline within 48 hours. Best fit for sterile medical devices requiring ISO 11607-compliant validation. ## What Happens Next ### Who A packaging validation specialist with ISO 11607 expertise ### When Within one business day ### About Your device, packaging system, sterilization method, and submission timeline ## Frequently Asked Questions How long does packaging validation typically take? Timeline depends on scope. A straightforward seal and integrity validation for a single packaging configuration takes 6–8 weeks. If you need accelerated aging (ASTM F1980), add 4–8 weeks for the aging study itself. Distribution simulation (ASTM D4169/ISTA) adds another 2–3 weeks. Our pre-validated packaging systems can eliminate 8–12 weeks by starting with a system that's already been through these tests. What is included in an ISO 11607 packaging validation? A complete ISO 11607 validation includes three phases: packaging system qualification (material specs, seal parameters), performance testing (seal strength, burst, dye penetration, microbial barrier), and stability testing (accelerated and/or real-time aging). We also include distribution simulation testing per ASTM D4169 or ISTA protocols when required. The deliverable is a complete documentation package with test protocols, raw data, statistical analysis, and a summary report formatted for regulatory submission. What are pre-validated packaging systems and how do they save time? Pre-validated systems are LSO's standard pouch and tray configurations that have already completed seal testing, accelerated aging, and distribution simulation. If your device fits within a pre-validated format, you can skip those tests entirely and go straight to device-specific verification. This typically saves 8–12 weeks compared to validating a custom packaging system from scratch — a significant advantage when your submission timeline is tight. Can you validate packaging that we designed ourselves? Absolutely. We validate customer-designed packaging systems as well as our own pre-validated formats. We'll review your packaging design, identify the right test matrix based on your device and sterilization method, and execute the full validation. If we spot potential issues during protocol review — such as seal geometry concerns or material compatibility questions — we'll flag them before testing begins so you don't waste time on a design that won't pass. What happens if a test fails during validation? Failures during validation aren't uncommon — that's why we test. If a seal strength or integrity test fails, we investigate root cause (seal parameters, material specs, equipment calibration) and recommend corrective action. Depending on the failure, this might mean adjusting seal temperature or dwell time and retesting. We don't start the investigation from scratch — we build on the data we already have. You'll receive a deviation report with root cause analysis and the path forward. Do you support both FDA and EU MDR submissions? Yes. Our test reports and documentation packages are formatted to meet both FDA 510(k) requirements and EU MDR technical file expectations. We reference the applicable standards (ISO 11607, ASTM F1980, ASTM D4169, ISTA) and include the level of detail that reviewers expect. Many of our customers submit to both regulatory bodies using the same validation package. How do I know if I need accelerated aging? If your device has a labeled shelf life or expiration date, you need aging data to support that claim. Accelerated aging per ASTM F1980 lets you generate shelf life data in weeks instead of years — typically a 10:1 acceleration ratio. If you're launching soon and need shelf life claims for your submission, accelerated aging is almost always required. Real-time aging runs concurrently and serves as confirmation over the actual shelf life period. What are the most common packaging validation mistakes? The five mistakes we see most often: (1) starting accelerated aging before finalizing seal parameters — every parameter change forces a restart; (2) under-scoping distribution simulation to the lab and skipping ASTM D4169 or ISTA 3A; (3) using ASTM F1929 dye penetration alone without ASTM F88 seal strength as a baseline; (4) treating ISO 11607-1 (barrier system) and 11607-2 (process) as a single test instead of two separate qualifications; and (5) generating test data without traceable protocols, so an auditor can't link the data back to a controlled procedure. We catch these during protocol review, before they cost you weeks.