GXPERIA
Quality Compliance Solutions
Stability & Storage · Excursion Assessment
Shelf Life Impact After a Temperature Excursion
Estimates the loss of labeled shelf life caused by a short, out-of-range temperature exposure, using an accelerated-stability degradation rate.
months
%
%
%
months
From the accelerated stability study at the relevant elevated condition.
°C
hrs
Duration is converted to days (÷24) for the calculation.
Conclusion
—
Enter values to calculate.
Method:
Reference: Schofield, T. — "Assuring Continued Efficacy of Biopharmaceuticals After Distribution Temperature Excursions," AAPS, 2007.
loss/day = (loss % ÷ period days) → loss during excursion = loss/day × excursion days → shelf-life loss = (shelf life ÷ spec range) × loss during excursion.Reference: Schofield, T. — "Assuring Continued Efficacy of Biopharmaceuticals After Distribution Temperature Excursions," AAPS, 2007.
Rafat Alghubari
Founder & Managing Director
Gxperia.com