Accelerated stability model for predicting shelf-life.

Abstract

Second- and higher-order degradation reactions sometimes cannot be approximated with linear or exponential relationships and need to be appropriately modeled. Events above the COULTER HmX Analyzer white blood cell (WBC) counting threshold were recorded for the HmX PAK reagent system stored at five elevated temperatures. An accelerated stability model for a second-degree polynomial degradation pattern was used. The shelf-life of the reagent, along with 95% lower bound confidence intervals, is predicted using the same pattern of degradation as well as the Arrhenius approximation. Experiments indicated that the degradation of the HmX PAK reagent occurred in two phases, the lag phase and the degradation phase, in all tested temperatures. The phase durations are temperature-dependent, and the Arrhenius approximation is appropriate (P=0.639). The degradation of the reagent during the lag phase was experimentally undetectable. Changes of the reagent were nonsignificant for a predicted period of 164 days at 25 degrees C. The rate of degradation increased significantly later on during the degradation phase. The lower bound of the 95% confidence interval of this prediction indicated that it would take at least 326 days before the HmX PAK reagent would have any performance issue related to aging at storage temperature.