Accelerated Aging Testing for Medical Device Packaging
Takes about 60–90 seconds.
Typical response within 1 business day.
15-minute consult with a steam specialist.
Accelerated aging is a standardized method that uses elevated temperatures to simulate the long-term shelf life of a sterilized medical device package within weeks instead of years, following ASTM F1980.
LSO performs accelerated aging to help manufacturers establish initial shelf-life claims before real-time data is available. A product can be released to market based upon successful Accelerated Aging test results that simulate the period claimed for product expiration date (1 year, 2 years, etc). Accelerated Aging data is recognized by regulatory bodies as a conservative estimate of the shelf life but is only accepted until those tests can be repeated on “real time” aged samples.
90 Second Video Overview
Accelerated Aging Calculator (ASTM F1980)
This accelerated aging calculator uses the Arrhenius equation defined in ASTM F1980 to estimate how many days of elevated-temperature aging are required to simulate real-time shelf life.
Accelerated Aging Calculator
This calculator generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of Sterile Medical Device Packages.
Q: How does the accelerated aging calculator work?
A: It applies the Arrhenius equation from ASTM F1980 to calculate an aging factor and convert real-time shelf life into elevated-temperature aging duration.
Q: What temperature should I use for accelerated aging?
A: ASTM F1980 commonly uses 55°C with a Q10 of 2 unless material-specific data supports a different Q10.
Q: Can this calculator replace real-time aging?
A: No—real-time aging is still required; the calculator provides an initial estimate for shelf-life claims.
Example Aging Duration Calculation
Using an elevated temperature of 55°C and an ambient temperature of 23°C with Q10 = 2:
- Aging Factor (AF) = Q10^((Test Temp – Ambient Temp) / 10)
- AF = 2^((55 – 23) / 10) ≈ 9.2
- Three-year shelf life = 1,095 days
- 1,095 / 9.2 ≈ 119 days of accelerated aging
When Accelerated Aging Is Appropriate
Accelerated aging is used when the sterile barrier system is made from heat-stable, well-characterized materials, and the device has a shelf-life claim of five years or less. It provides a scientifically supported estimate of long-term stability when paired with real-time data.
Common applications include:
- Tyvek/poly pouches
- PETG trays with Tyvek lids
- Film-foil pouch systems
- Rigid and semi-rigid sterile barrier systems
- Devices sterilized by EO, gamma, steam, or e-beam
Q: When is accelerated aging acceptable for medical devices?
A: It is acceptable when packaging materials and sterilization methods are stable under elevated temperatures and supported by historical performance data.
When Accelerated Aging Should Not Be Used
Accelerated aging alone is not sufficient when:
- Packaging materials lack heat-stability data
- Components soften, deform, or absorb moisture at test temperatures
- Novel materials may degrade through oxidation or humidity, not heat
- Real-time aging is required for full regulatory verification
Q: When is accelerated aging not enough on its own?
A: It is not enough when material heat stability is unknown or when regulators require real-time aging to verify long-term performance.
Test Parameters and Methodology
LSO performs accelerated aging in accordance with ASTM F1980 using validated environmental chambers and continuous monitoring. The Arrhenius equation determines the relationship between elevated temperature and the equivalent real-time aging duration.
Typical parameters:
- Test temperature: 50–60°C (most commonly 55°C)
- Ambient baseline: 22–25°C
- Q10 factor: Default of 2.0 which indicates that the chemical reaction rate of the materials doubles for every 10°C unless material-specific data supports otherwise.
- Relative humidity: Can be controlled or uncontrolled depending if the package materials or device is hydrolytic or corrosive. If controlled, 45% to 55% is suggested by the standard. If uncontrolled, the relative humidity drifts below 20% RH throughout the course of the aging cycle.
- Duration: Determined by shelf-life claim and selected test temperature
Q: What is the standard temperature for accelerated aging?
A: Most studies use 50–60°C with a Q10 value of 2.0 to simulate long-term shelf life per ASTM F1980.
Q: How long does accelerated aging take to simulate 1 year?
A: At 55°C and 23°C with Q10 = 2, one year of real-time aging can be simulated in about 40 days.
What Follows Accelerated Aging
After accelerated aging, samples undergo sterile barrier integrity testing to confirm package performance throughout the simulated shelf life.
LSO performs:
Q: What tests follow accelerated aging?
A: Seal strength, bubble leak, dye penetration, and visual inspection are typically used to confirm sterile barrier integrity.
Regulatory Framework
Accelerated aging supports FDA 510(k) and CE marking submissions when paired with ongoing real-time studies. LSO conducts testing in alignment with:
- ASTM F1980 – Accelerated Aging of Sterile Barrier Systems
- ISO 11607-1 & 11607-2 – Packaging for Terminally Sterilized Medical Devices
- AAMI TIR22 – Guidance for Stability Testing of Medical Devices
Q: What standard governs accelerated aging?
A: ASTM F1980 is the primary standard for accelerated aging of medical device packaging.
How LSO Executes Accelerated Aging
LSO manages the entire accelerated aging workflow, including sample handling, chamber monitoring, and downstream sterile barrier testing. Our process includes:
- Define shelf life requirements
- Determine accelerated aging duration using Arrhenius modeling
- Place samples into validated aging chambers
- Continuously monitor temperature and humidity
- Withdraw samples at planned intervals
- Conduct sterile barrier integrity testing
- Compile complete, audit-ready documentation
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.
Q: Why choose LSO for accelerated aging?
A: LSO integrates validated chambers, in-house package integrity testing, and regulatory-focused reporting to deliver faster, audit-ready shelf-life data.
Talk to a Medical Package Testing Specialist
Speak with an LSO specialist to scope your accelerated aging study, calculate duration, or integrate downstream sterile barrier testing.
Frequently Asked Questions About Accelerated Aging
What is accelerated aging?
Accelerated aging is a test method that uses elevated temperatures in a shortened period of time to simulate the long-term shelf life of sterile medical device packaging.
Which standard governs accelerated aging for medical device packaging?
ASTM F1980 is the primary standard that defines how to perform accelerated aging for sterile barrier systems used with terminally sterilized medical devices.
How does the accelerated aging calculator work?
The accelerated aging calculator applies the Arrhenius equation from ASTM F1980 to calculate an aging factor. The equation considers elevated temperature, ambient (real-time) temperature, and a Q10 factor to determine actual aging durations that help support shelf-life claims.
What temperatures are typically used for accelerated aging?
Most accelerated aging studies use temperatures between 50 °C and 60 °C, with 55 °C being the most common test temperature for sterile barrier systems.
What is Q10 in accelerated aging, and what value does LSO use?
Q10 is a temperature coefficient that describes how reaction rates change with temperature, and LSO typically uses a Q10 value of 2.0 unless material-specific data supports a different value.
How long does accelerated aging take to simulate one year of shelf life?
At 55 °C with an ambient (real-time) temperature and a Q10 of 2.0, one year of real-time shelf life can be simulated in 40 days. If any of the temperatures or factors change, the duration changes.
Does accelerated aging replace real-time aging?
Accelerated aging does not replace real-time aging; it provides an initial estimate of shelf-life that must be confirmed with ongoing real-time aging studies.
What types of packaging are suitable for accelerated aging?
Accelerated aging is suitable for heat-stable, sterile barrier systems such as Tyvek pouches, PETG trays with Tyvek lids, film-foil pouches, and other packaging materials with documented temperature stability.
When is accelerated aging not appropriate?
Accelerated aging is not appropriate when packaging materials lack heat-stability data, when temperature is not the primary driver of degradation, or when regulators require real-time data for final shelf-life verification.
What tests are performed after accelerated aging at LSO?
After accelerated aging, LSO performs sterile barrier integrity testing such as visual inspection, bubble leak testing, dye penetration testing, and quantitative seal strength testing to confirm package performance over the simulated shelf life.
Our Services
Takes about 60–90 seconds.
Typical response within 1 business day.
15-minute consult with a steam specialist.
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