Accelerated Aging Testing
By artificially increasing stress on your products, you can learn how the cumulative effect of time, temperature, and humidity will affect product safety and efficacy. Accelerated aging helps manufacturers establish proper storage conditions and shelf-life dates.
The components used in the creation of medical devices and pharmaceuticals will change over time; this passage of time will have an effect on component materials, as can excursions in specified storage conditions, such as temperature and humidity. Understanding when and how changes occur to these products, especially changes that affect efficacy, stability, or safety, helps manufacturers establish proper storage conditions and shelf-life dates.
Real-time aging studies determine how long it actually takes for a product to fail specifications when stored at recommended storage conditions. This study, while highly accurate, takes time: years, in many cases. To decrease time-to-market, an accelerated aging study may be performed. By increasing the environmental stress on a product, such as elevated temperature or humidity, we can artificially simulate the effects of longer-term aging in a shorter period of time. Through the Arrhenius equation we can predict the impact of temperature on reactions, allowing us to scientifically estimate the shelf life of known components, or combinations of known components.
During an accelerated aging study, test articles are stored in an environmental chamber under controlled humidity and elevated temperature for a specific amount of time, which simulates real-time exposure in a shorter time frame.Following the accelerated aging, the test article may be further analyzed for sterility, concentration analysis, mechanical testing, potency assay, or other evaluations.
- Standards
-ISO / ANSI / AAMI 11607
-ASTM F1980
- Accelerated Aging Test Parameters
Biolink offers accelerated aging at all standard ICH conditions, as well as custom conditions, depending upon your test protocol. Our available conditions include, but are not limited to:
If you have additional questions about the test, or would like to consult with the experts at Biolink, ASK OUR EXPERT
