In order to explore the impact of sterilizing filtration in the produce process of semi-finished products on the quality attributes of trivalent rotavirus vaccines,and to evaluate the feasibility of implementing sterilizing filtration in this produce process,sterilizing filtration experiments of 22 batches of semi-finished product were conducted in two stages.The test filter membrane had a pore size of 0.22 μm and was made from polyvinylidene fluoride(PVDF).The effect of sterilizing filtration on virus titer,appearance,pH value,osmotic pressure,and clarity of the test products was investigated,and a bacterial interception test on the proposed selected filter membrane material was performed.The results indicated that the PVDF sterilizing filter with a pore size of 0.22 μm for the sterilizing filtration of the semi-finished trivalent rotavirus vaccines did not significantly affect the virus titer,appearance,pH value,and osmotic pressure of the test products(P＞0.05),but notably enhanced the clarity of the test products(P＜0.05).This research provides valuable data and insights for applying sterile filtration to the formulation process of the semi-finished trivalent rotavirus vaccines.
维普
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