Shelf-life Q10 estimator

FAQ

What is the Q10 accelerated-aging rule of thumb?

A common planning formula is real-time equivalent ≈ accelerated days × Q10^((T_accelerated − T_realtime)/10). Q10 = 2 is a frequent default meaning the degradation rate roughly doubles for each 10 °C rise. It is a heuristic, not a universal material constant.

How does ASTM F1980 relate to this estimator?

ASTM F1980 is the widely cited standard guide for accelerated aging of sterile barrier systems and medical devices. It discusses Q10-based aging time calculations, temperature selection, and the need to justify assumptions. This page implements the familiar Q10 power formula as an educational sketch — follow F1980 and your stability protocol for the official study.

When is Q10 = 2 a bad assumption?

Humidity-sensitive packaging, protein assays, some adhesives, batteries and multi-mechanism failure modes often deviate from a single Q10. If your material system is not thermally dominated, do not treat the calculator output as a shelf-life claim.

Does this replace real-time aging?

No. Accelerated aging supports provisional dating; real-time confirmation is typically still required for the labeled shelf life. Regulators expect a protocol, acceptance criteria and justification, not a web-form printout.

How should sterilization interact with aging studies?

Age the product in the sterilized, finished configuration whenever the process can change materials or residuals. Changing modality or dose after aging may invalidate the claim. Pair this estimator with your sterilization validation plan.

What temperatures should I enter?

Use the accelerated chamber set point and the intended real-time storage temperature in °C, consistent with your protocol. Do not mix ambient “room temperature” hand-waves with a precise accelerated set point without documenting both.