This calculator can be used to determine appropriate conditions for an accelerated ageing protocol based on your intended real-time storage conditions.
Accelerated ageing techniques are based on the theory that chemical reactions which involve the deterioration of materials are related to the Arrhenius reaction rate. We use this equation to develop accelerated test protocols and mimic real-time storage.
ASTM F1980 uses the Arrhenius equation to provide information on developing accelerated test protocols. We follow guidance from this standard when developing these protocols and this calculator and accompanying information has been constructed using guidance in the standard.
Why do an accelerated test?
When taking a new drug to market, it's essential to know that the product in combination with its packaging will maintain its quality for the duration of its shelf life. This is why the pharmaceutical industry places a heavy emphasis on shelf-life testing or stability testing. It's for drug manufacturers to investigate and prove that their product and packaging selection can withstand the time and defined environmental conditions.
Shelf-life or stability testing can be conducted as an accelerated test which gives an indication of the performance of the product and packaging under the intended storage conditions without having to wait for the duration of the shelf life. Using scientific principles we can create a protocol for a shorter and more aggressive test to mimic longer term conditions at a lower/less aggressive temperature. Although ‘real-time’ stability studies are essential for ensuring the validity of results an accelerated test can quickly flag any potential issues and allow manufacturers to rectify these before making final decisions on their storage protocol.
The calculator – input your data in each field
What each input means (explanation)
- TAA – Accelerated Ageing Temperature
- TRT – Ambient Temperature
- Q10 –The Q10 is a constant. It is an ageing factor for 10°C increase or decrease in temperature. The value is determined through testing of materials at a variety of temperatures and is generally considered outside the scope of the development of accelerated test protocols. Q10 values between generally range between 1.8 and 2.5 however a value of 2 is common practice for these test protocols and is considered conservative.
- AAF – Accelerated ageing factor. In this case it is a calculated ratio to equate the same level of physical property change as product stored at the real time conditions.
- RT – Real-Time