EVALUATION OF EQUIPMENT SIMILARITY AND THE ROBUTNESS OF PYROGEN TEST PROCEDURE IN VACCINES AND BIOLOGICALS ON EXPERIMENTAL RABBITS AT NICVB

Abstract

Evaluating the similarity of equipments and the robustness of the pyrogen test procedure in vaccines/biological products on experimental rabbits was performed on on two pyrogen measuring systems currently available at NICVB: Pyrogen Monitor and Pyromon Pro. The procedure was repeated 3 times on each machine system by the same technical persons, same materials, same working environmental conditions and on the same batch of SAT samples. Test results show that the average total temperature response of rabbits on 2 machines over 3 times was 0.54⁰C and 0.35⁰C respectively. Comparing the variance of the two machines shows that there is equal, from which the t-test = 1,044 is calculated, which is smaller than the t-table (t-table = 2,776) with 95% confidence. In addition, the coefficient of variation (CV) values of the two machine systems both reached under 50%, meeting the CV standards for an invivo test.  Thus, these two pyrogen measuring systems are similar equipment, and the process of testing pyrogens in vaccines and biological products on experimental rabbits at NICVB meets requirements of the robustness.