Accelerated and Real Time Ageing
What is accelerated ageing?
Accelerated ageing subjects samples to elevated temperatures for specific periods of time. It is used to simulate the effects of real-time ageing and provides data which allows the manufacturer to accurately predict the effect of real-time ageing on his package/product.
Concurrent with the accelerated ageing process, the manufacturer must also conduct real-time studies in order to substantiate the data generated during the accelerated ageing process.
Why do accelerated or real time ageing?
The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period (from one to five years) without any decrease in performance that may affect safety and efficacy when the products are used.
It is necessary to conduct accelerated ageing tests to generate data quickly to:
- Prove that the packaging provides a sterile barrier for the defined lifetime of the product or up to point of use
- Bring product to market at the earliest possible time
Accelerated ageing techniques are based on the assumptions that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate function. This function states that a 10°C increase or decrease in the temperature of a homogenous process, results in approximately a two times or ½ time change in the rate of a chemical reaction.
At 55°C, 6.5 weeks is equivalent to 1 year on-the-shelf. For example, at 55°C, two years would be equivalent to 13.0 weeks and five years would be 32.5 weeks.
Anecto Ltd. provides a range of accelerated ageing conditions with and without humidity control in chambers which accommodate both large pallets and small packages.
- ISO 11607 – Packaging for terminally sterilised medical devices
- ASTM F1980 – Standard Guide for accelerated ageing of Sterile Barrier Systems for Medical Devices
For more information on Ageing or any of Anecto’s testing, and technical support services, please…
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Case Study – Emerson Network Power
How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.