VALIDATION OF SAR (IVACRIG) STERILITY TESTING PROCESS BY MEMBRANE FILTRATION METHOD

Abstract

Purified anti-rabies serum (IVACRIG) is a product of the Institute of Vaccines and Medical Biological Products (IVAC), indicated for both adults and children in cases of bites, scratches, or licks on broken skin by animals suspected of being rabid. It helps to prevent infection locally while waiting for the vaccine to produce antibodies after 7-10 days [1]. In this study, we used 60 vials of IVACRIG(3 series) along with standard microorganisms to evaluate the suitability of the membrane filtration method for sterility testing through the growth of microorganisms in the culture. The study results showed that the sterility test of the 3 series IVACRIGmet the evaluation criteria: there was a clear growth of bacteria and fungi after inoculation with challenge microorganisms in the culture. Therefore, the validation test met the requirements, the sterility test procedure by membrane filtration method for purified anti-rabies serum (IVACRIG) produced at IVAC is suitable for implementation in practice.