ACCELERATED DEGRADATION TESTS ON SOME IMMUNOLOGICAL PRODUCTS

The accelerated degradation test was applied for predicting the stability of Schick test toxin, fluid-killed Japanese encephalitis vaccine and freeze-dried BCG vaccine. The predicted degradation rate at a given low temperature was calculated on the basis of the hypothesis that the deterioration rate was a monomolecular reaction from the results obtained with experiments at some appropriate elevated temperatures. In both the first two cases the calculated values were fairly equivalent to the empirical ones obtained on actual prolonged storage at the corresponding low temperature. As the degradation rate of BCG vaccine did not necessarily follow the hypothesis of monomolecular reaction, some devices were attempted. © 1979 The International Association of Biological Standardization.