Accelerated Aging Testing
Bring your medical device to market faster. Our Accelerated Aging studies simulate years of shelf life in a matter of weeks, providing the essential data needed to support your expiration dating and product stability.
Before a medical device can be launched, manufacturers must prove that both the device and its packaging will remain safe and functional until the expiration date. Since waiting years for „real-time” aging is often impractical for product launches, ASTM F1980 provides a scientifically validated method to speed up the process. At EBI, we utilize high-precision environmental chambers to simulate long-term storage under controlled thermal stress.
The Science of Accelerated Aging
Accelerated aging is based on the Arrhenius Reaction Rate Function, which states that a rise in temperature increases the rate of chemical reactions. By increasing the storage temperature, we can simulate the degradation that would occur over a longer period at ambient temperature.
We use accepted mathematical algorithms to calculate your study:
- Target Shelf Life: The desired expiration period (e.g., 1, 3, or 5 years).
- $Q_{10}$ Factor: The aging factor (defaulted to 2.0 per industry standard), which assumes the reaction rate doubles with every 10°C increase in temperature.
- Accelerated Aging Temperature ($T_{AA}$): Typically 50°C to 60°C, ensuring we do not exceed the glass transition temperature of your materials.
- Ambient Temperature ($T_{RT}$): The assumed real-world storage temperature (typically 20°C–25°C).
Why Accelerated Aging is Critical
Accelerated aging is rarely performed in isolation. It is the foundation for a suite of stability tests:
- Package Integrity: Proving that the sterile barrier (pouches, trays) does not degrade over time.
- Functional Testing: Ensuring the device still performs according to its specifications after „aging.”
- Toxicological Stability: Ascertaining that the materials do not leach new harmful substances as they age.
- Regulatory Requirement: Essential for MDR 2017/745 and FDA submissions to justify your product’s „Use By” date.
Methodology & Environmental Conditioning
EBI manages the entire aging process in our state-of-the-art microbiology and stability wing:
- Protocol Design: We help you calculate the required chamber time based on your target shelf life and selected temperatures.
- Chamber Loading: Test articles are placed in environmental chambers with strictly controlled temperature.
- Real-Time Parallel Study: Per regulatory requirements, we also initiate a real-time aging study to eventually validate the accelerated results.
- Post-Aging Testing: Once the „aging” cycle is complete, the samples undergo Seal Strength, Bubble Emission, or Functional Assays.
Sample Requirements & Timeline
- Turnaround Time: Calculated as the Accelerated Aging Time + 2 weeks (for final reporting and post-aging tests).
- Sample Quantity: Dependent on the number of intervals you wish to test (e.g., T=0, T=1 year, T=5 years) and your specific risk assessment.
- Compliance: Fully compliant with ASTM F1980 „Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.”
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ
Does Accelerated Aging replace Real-Time Aging?
No. While regulatory bodies allow you to market your device based on accelerated data, you are required to conduct a Real-Time Aging study in parallel to confirm the results as the product naturally ages.
What is the $Q_{10}$ value?
The $Q_{10}$ value is an aging factor. A value of 2.0 is the most common and conservative estimate used for medical devices. While it can be changed based on specific material data, EBI recommends holding this constant to ensure regulatory acceptance.
Can all materials be accelerated?
Most polymers and metals can. However, if your device contains components that melt or change properties at low temperatures (like certain waxes or biological components), the $T_{AA}$ must be carefully selected to avoid „unnatural” failure modes.
Does Accelerated Aging replace Real-Time Aging?
No. While regulatory bodies allow you to market your device based on accelerated data, you are required to conduct a Real-Time Aging study in parallel to confirm the results as the product naturally ages.
What is the $Q_{10}$ value?
The $Q_{10}$ value is an aging factor. A value of 2.0 is the most common and conservative estimate used for medical devices. While it can be changed based on specific material data, EBI recommends holding this constant to ensure regulatory acceptance.
Can all materials be accelerated?
Most polymers and metals can. However, if your device contains components that melt or change properties at low temperatures (like certain waxes or biological components), the $T_{AA}$ must be carefully selected to avoid „unnatural” failure modes.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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