THE RESEARCH IN THE IMPLEMENTATION OF MEMBRANE FILTRATION METHOD FOR STERILITY TESTING OF THE JEVAX JAPANESE ENCEPHALITIS VACCINE (VABIOTECH) ON THE STERITESTTM SYMBIO LFH PUMP KIT SYSTEM, 2 MEDIA
DOI:
https://doi.org/10.56086/jcvb.v4i1.137Keywords:
sterility testing, the membrane filtration method.Abstract
The sterility testing process using the membrane filter method is one of the standard methods to determine the safety of vaccines before they are circulated on the market. To determine the suitability of the aseptic process using the membrane filtration method, the Department of Experimental Environment researched and selected three series of test samples of the Jevax Japanese Encephalitis vaccine (Vabiotech) with the preservative content of thiomersal not exceeding ≤ 0.012% (w/v) and conducted sterility testing using the membrane filtration method on the Steritet TM Symbio LFH Pump Kit System in two media. The results showed clear growth of microorganisms in the environmental cups of 03 series of test samples after inoculating no more than 100 CFU of the challenge strain. This shows that the sterility testing process using the Steritest TM Symbio LFH Pump Kit system in two media for Jevax vaccine samples (Vabiotech) is completely suitable. Therefore, for vaccines containing thiomersal preservative content not exceeding ≤ 0.012% (w/v), the above sterility testing process can be applied with high reliability.
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