Accelerated Aging

Reduce the time it takes to learn how your products will change over time with 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.

What is Accelerated Aging?

The components used in the creation of medical devices and pharmaceuticals will change; the 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

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 35°C / 65% RH
  • 40°C / 75% RH
  • 45°C
  • 50°C
  • 55°C
  • 60°C
  • 65°C
  • 70°C
  • 75°C

Sample Needed

Depends on testing requirements

Turn-Around Time

1 week after study ends.

Toxikon’s 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.

Toxikon’s Expertise in Accelerated Aging

At Toxikon, 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. Our approach involves three main values:
  1. We are committed to quality and scientific excellence.
  2. Our client-centric, collaborative approach will give you confidence knowing that our scientists understand your application.
  3. The know-how to navigate the regulatory landscape for your product’s development path
Test NameSample NeededTurn-Around Time
25°C / 60% RH
Depends on testing requirements1 week after study ends
30°C / 65% RH
Depends on testing requirements1 week after study ends
35°C / 65% RH
Depends on testing requirements1 week after study ends
40°C / 75% RH
Depends on testing requirements1 week after study ends
45°C
Depends on testing requirements1 week after study ends
50°C
Depends on testing requirements1 week after study ends
55°C
Depends on testing requirements1 week after study ends
60°C
Depends on testing requirements1 week after study ends
65°C
Depends on testing requirements1 week after study ends
70°C
Depends on testing requirements1 week after study ends
75°C Depends on testing requirements1 week after study ends