Real Time Aging Testing for Medical Device Packaging
60 second video overview
Typical response within 1 business day.
15-minute consult with a packaging specialist.
Real-time aging provides the actual shelf-life evidence required for sterile barrier validation. Unlike 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 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 requires manufacturers to generate real-time data demonstrating that sterile barrier systems maintain integrity over the complete shelf-life duration.
60 Second Video Overview
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 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:
- Defining study duration (1, 2, 3+ years)
- Selecting required time points (6, 12, 18, 24 months)
- Allocating sterilized samples for each interval
- Placing samples in controlled 22–25°C rooms
- Pulling samples at each time point
- Performing package integrity testing
- Recording and reviewing results
- 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
- Study setup, chamber qualification, and sample intake
- Continuous temperature monitoring with alerting
- Scheduled time-point pulls
- In-house sterile barrier integrity testing:
- Data verification and documentation
- Final reporting aligned with 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 + 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, LSO’s specialists can help design and execute real-time and accelerated aging studies with full in-house testing support.
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.
Our Services
60 second video overview
Typical response within 1 business day.
15-minute consult with a packaging specialist.