STUDYING ON APPLICATION OF STERILITY TEST PROCESS FOR TYPHOID VI POLYSACCHARIDE VACCINE USING MEMBRANE FILTER METHOD ON STERITESTTM SYMBIO LFH PUMP KIT, 2 MEDIA SYSTEM

Abstract

Currently, in Vietnam, there are some methods, such as direct cultivation or membrane filter methods that are used for sterility test for vaccines and biological products according to WHO guideline, European Pharmacopoeia,… in order to detect exogenous which is living organism.  The membrane filter method on the Steritest TM Symbio LFH Pump Kit System, 2 media is applied in vaccines and biological sterility test. This method uses acomplete closed system, simplizes process and gives high quality with high reliability. To ensure the suitability of steriled test by membrane filter for vaccines that contains phenol as a preservative, Typhoid Vi Polysaccharide vaccine was selected to test on Steritest TM Symbio LFH Pump Kit system, 2 media. After cultivate less than 100CFU of challenge microbial strain in samples’ media bottles, observe the growth appearance of microorganisms in 3 tests. The research results showed that sterility test on Steritest ^TM Symbio LFH Pump Kit System, 2 media for Typhoid Vi Polysaccharide vaccine is suitable. Therefore, the sterility test using  membrane filter method can be applied to Typhoid Vi Polysaccharide vaccine with high reliability