# > Discover how real-time aging measures packaging performance over time, ensuring safety and compliance under ISO 11607. Source: https://lso-inc.com/medical-package-testing/services/real-time-aging/ --- # Real-Time Aging and ISO 11607 Requirements Explained [Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) ![Real-Time Aging and ISO 11607 Requirements Explained](https://lso-inc.com/api/media/file/Real-timeagingandISOcomplianceinfographic.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 Real-time aging provides the **actual shelf-life evidence** required for sterile barrier validation. Unlike [accelerated aging](https://lso-inc.com/medical-package-testing/services/accelerated-aging/)—which estimates long-term performance using elevated temperatures—real-time aging measures how a packaging system performs **over the true passage of time** under controlled room temperature conditions.  Real-time aging is **mandatory under** [**ISO 11607**](https://lso-inc.com/medical-package-testing/standards/iso-11607/) for verifying the shelf-life claims of terminally sterilized medical devices. It confirms that sterile barrier systems maintain integrity, material stability, and seal performance throughout the entire claimed shelf life.  **Q: Why is real-time aging mandatory under ISO 11607?**  A: [ISO 11607](https://www.iso.org/standard/70799.html) requires manufacturers to generate real-time data demonstrating that sterile barrier systems maintain integrity over the complete shelf-life duration.  ## What Real-Time Aging Is and Why It Matters Real-time aging evaluates how packaging materials, seals, and sterile barriers perform **at normal storage temperatures** over months or years. It provides:  - True, empirical shelf-life data  - Verification of accelerated aging assumptions  - Evidence required for regulatory submissions  - Long-term sterile barrier performance validation Real-time aging is the foundation for demonstrating stability and durability of sterile packaging over its intended lifespan.  **Q: Does real-time aging provide the actual shelf-life data regulators want?**  A: Yes. Real-time aging is the only method that produces direct, time-based shelf-life evidence for sterile barrier systems.  ## Environmental Conditions Used for Real-Time Aging (22–25°C) Real-time aging must reflect real-world storage conditions. ISO 11607 requires manufacturers to maintain stable, controlled environments throughout the study.  Typical conditions:  - **Temperature:** 20°C–25°C  - **Most common range:** **22°C–25°C**  - **Humidity:** Ambient unless otherwise justified  - **Lighting:** Controlled, non-degrading exposure  - **Monitoring:** Continuous environmental logging with excursion alarms  LSO’s real-time aging rooms are fully mapped, monitored, and designed to ensure reproducible stability conditions throughout multi-year studies.  **Q: What temperature is used for real-time aging?**  A: Real-time aging is typically performed at 22–25°C, reflecting standard ambient storage conditions.  ## LSO’s Real-Time Aging Capabilities (California Facility) LSO conducts real-time aging exclusively in our **California facility**, equipped for long-term stability studies requiring strict environmental control and traceability.  **Facility Highlights**  - Temperature-controlled rooms maintained between **22°C–25°C**  - Full **temperature mapping** prior to study initiation  - Continuous environmental monitoring with excursion alarms  - Segregated shelving for study groups and time points  - Co-located sterile barrier integrity testing (no cross-facility transport)  - Long-term capacity for multi-year studies and multiple SKUs  **Q: Why does LSO conduct real-time aging in California only?**  A: Our California facility houses mapped, monitored rooms purpose-built for long-duration stability studies and co-located package integrity testing.  ## Real-Time Aging vs Accelerated Aging: What’s the Difference? Real-time aging and accelerated aging serve different—yet complementary—roles in shelf-life validation.  | Category | Real-Time Aging | Accelerated Aging (ASTM F1980) | | --- | --- | --- | | Purpose | Establishes actual shelf-life data | Estimates shelf-life before real-time results exist | | Temperature | 20–25°C (typically 22–25°C) | 50–60°C depending on material limits | | Basis | Measured passage of time | Arrhenius equation (aging factor) | | Regulatory Role | Mandatory under ISO 11607 | Supports initial shelf-life claims only | | Testing | Integrity tests at every time point | Integrity testing after AA duration | | Timeframe | Months to years | Weeks to months | | When Used | All sterile barrier claims | Early validation + pre-launch justification | | Relationship | Confirms AA assumptions | Provides early data before real-time completes | **Q: Can accelerated aging replace real-time aging for shelf-life validation?**  A: No. [Accelerated aging](https://lso-inc.com/medical-package-testing/services/accelerated-aging/) is useful early in development, but real-time aging is mandatory for confirming shelf-life claims.  ## How Real-Time Aging Studies Are Planned and Executed Because real-time aging cannot be compressed, study planning should begin early in the development cycle.  A typical study includes:  1. Defining study duration (1, 2, 3+ years)  2. Selecting required time points (6, 12, 18, 24 months)  3. Allocating sterilized samples for each interval  4. Placing samples in controlled 22–25°C rooms  5. Pulling samples at each time point  6. Performing package integrity testing  7. Recording and reviewing results  8. Issuing a final real-time aging report  **Q: How early should real-time aging be started?**  A: As early as possible, because real-time duration cannot be shortened and is required for all final shelf-life claims.  ## Real-Time Aging Workflow at LSO LSO manages the full workflow to ensure data integrity and regulatory acceptance.  **Our Process**  1. Study setup, chamber qualification, and sample intake  2. Continuous temperature monitoring with alerting  3. Scheduled time-point pulls  4. In-house sterile barrier integrity testing:  5. - [Seal strength](https://lso-inc.com/medical-package-testing/services/peel-strength-testing/)  - [Bubble leak](https://lso-inc.com/medical-package-testing/services/bubble-emission-testing/)  - [Dye penetration](https://lso-inc.com/medical-package-testing/services/dye-penetration-testing/)  - [Visual inspection](https://lso-inc.com/medical-package-testing/services/visual-inspection/)  6. Data verification and documentation  7. Final reporting aligned with [ISO 11607](https://lso-inc.com/medical-package-testing/standards/iso-11607/) requirements  **Q: What happens at each time point?**  A: Samples are removed from aging rooms and undergo required package integrity testing to verify sterile barrier performance over time.  ### Why Medical Device Manufacturers Choose LSO LSO provides:  - ISO 13485-certified facilities  - Validated aging and environmental chambers with continuous monitoring  - Integrated [accelerated aging](https://lso-inc.com/medical-package-testing/services/accelerated-aging/) + sterile barrier testing  - Accelerated turnaround  - Regulatory expertise for 510(k), PMA, and global submissions  - Complete documentation packages for audits and submissions You reduce handoffs, shorten timelines, and receive shelf-life data with full regulatory alignment.  ## Talk to a Medical Package Testing Specialist If you’re planning a new shelf-life claim, updating your packaging system, or aligning your validation program with [ISO 11607](https://lso-inc.com/medical-package-testing/standards/iso-11607/), LSO’s specialists can help design and execute real-time and accelerated aging studies with full in-house testing support.  [Talk to a Packaging Specialist](https://lso-inc.com/contact/) ## Frequently Asked Questions About Real-Time Aging What is real-time aging? Real-time aging involves storing sterile packaging at controlled ambient temperatures (22–25°C) for the full claimed shelf life to generate actual aging data. Why is real-time aging mandatory? ISO 11607 requires real-time evidence to substantiate sterile barrier shelf-life claims. How long does real-time aging take? Exactly as long as the shelf-life claim. Real-time aging cannot be compressed. How often is testing performed? Testing occurs at each defined time point, commonly every 6–12 months. Where does LSO conduct real-time aging? In our mapped, monitored California facility. Can accelerated aging replace real-time? No. Accelerated aging provides early estimates; real-time aging provides mandatory confirmation. ## Ready to get started? [Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Explore Solutions](https://lso-inc.com/#solutions)