Understand Accelerated Aging Testing
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
- ICH Q1A-Q1F
Accelerated Aging Test Parameters
Toxikon 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:
| Test Name | Sample Needed | Turn-Around Time |
|---|---|---|
| 25°C / 60% RH | Depends on testing requirements | 1 week after study ends |
| 30°C / 65% RH | Depends on testing requirements | 1 week after study ends |
| 35°C / 65% RH | Depends on testing requirements | 1 week after study ends |
| 40°C / 75% RH | Depends on testing requirements | 1 week after study ends |
| 45°C | Depends on testing requirements | 1 week after study ends |
| 50°C | Depends on testing requirements | 1 week after study ends |
| 55°C | Depends on testing requirements | 1 week after study ends |
| 60°C | Depends on testing requirements | 1 week after study ends |
| 65°C | Depends on testing requirements | 1 week after study ends |
| 70°C | Depends on testing requirements | 1 week after study ends |
| 75°C | Depends on testing requirements | 1 week after study ends |
Toxikon’s Expertise in Accelerated Aging Testing
Our accelerated aging facility features state-of-the-art environmental stability chambers, supported by an on-site metrology and qualification department. Chambers are continuously monitored by an environmental monitoring system that alerts staff instantaneously in the rare event of an excursion. We understand the importance of sound science for drug and medical device development, and we are committed to supporting you through the entire product development cycle, from concept to final product.