SUITABILITY VALUATION OF BCG VACCINE STERILITY TESTING PROCEDURE BY DIRECT INOCULATION METHOD

Abstract

The live BCG (Bacille Calmette-Guérin) tuberculosis vaccine that derived from the Calmette-Guérin strain, is a product of the Institute of Vaccine and Medical Biologicals (IVAC). The sterility test is one of the essential tests recommended by the World Health Organization (WHO) to ensure the quality control of vaccines and biologicals by detecting foreign agents, including live microorganisms contaminating the product. At the National Institute for Control of Vaccines and Biologicals (NICVB), we conducted a study to evaluate the suitability of the BCG vaccines sterility testing procedure using the direct inoculation method. The study was performed on three batches of BCG vaccine. The results showed that the negative control, positive control, and sterility test of three batches of BCG vaccine met the required evaluation standards. All three time of trials showed the obvious growth of bacteria and fungi after inoculating the challenge microorganisms in the tubes containing the test samples. The study confirms that the procedure is capable of detecting microorganisms in the test samples at a concentration of <100 CFU. Therefore, the presence of the vaccine does not affect the growth of the strain. The sterility testing procedure using the direct inoculation method for BCG vaccine is suitable for application at NICVB