A kind of sterilization method of adjuvant for foot-and-mouth disease vaccine

Abstract

The invention discloses a sterilization method for an adjuvant used in a foot-and-mouth disease vaccine, which uses an on-line system for steam sterilization and integrity detection of the adjuvant sterilization filter, and sequentially includes: the integrity detection of the adjuvant sterilization filter before filtration , Adjuvant sterilizing filter online high-pressure steam sterilization, adjuvant filtration, integrity testing of adjuvant sterilizing filter after filtration. The sterilizing method adopts a filtering method to sterilize the adjuvant, which can more completely retain the active ingredients of the adjuvant, thereby more effectively improving the quality of the vaccine product, and making the foot-and-mouth disease vaccine safer, more stable and more effective.

Description

technical field [0001] The invention relates to a sterilization method in the technical field of biopharmaceuticals, in particular to a method for removing bacteria from an adjuvant used in a foot-and-mouth disease vaccine. Background technique [0002] Foot-and-mouth disease is an acute, febrile, highly contagious infectious disease caused by the foot-and-mouth disease virus that occurs on artiodactyls, mainly against artiodactyls. The disease has many transmission routes and fast speed, and has repeatedly broken out worldwide, causing huge political and economic losses. The World Organization for Animal Health (OIE) listed it as the first class A infectious disease. At present, the foot-and-mouth disease vaccine is one of the most important weapons to prevent and control the occurrence and prevalence of foot-and-mouth disease. [0003] Foot-and-mouth disease vaccine is an emulsion formed by emulsifying fat-soluble adjuvant and water-soluble antigenic substance. Therefore...

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Problems solved by technology

[0004] Since the foot-and-mouth disease vaccine is an emulsion, the adjuvant in the oil phase and the antigenic substance in the water phase need to be sterilized separately before mixing, otherwise the vaccine will be polluted and scrapped, making it unusable

Autoclaving is currently the most commonly used adjuvant sterilization method in the industry, but autoclaving will oxidize the surfactant contained in the adjuvant. The role of the surfactant is to promote the uniform mixing of the water phase and the oil phase to form an emulsion. Oxidation of surfactants prevents the water phase from being evenly dispersed in the oil phase, so autoclaving adjuvants will affect the quality of the foot-and-mouth disease vaccine by destroying the stability of the adjuvant

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