Blending

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Chapter: Pharmaceutical Microbiology : The Manufacture And Quality Control Of Immunological Products

Blending is the process in which the various components of a vaccine are mixed to form a final bulk. It is undertaken in a large, closed vessel fitted with a stirrer and ports for the addition of constituents and withdrawal of the final blend.


BLENDING

 

Blending is the process in which the various components of a vaccine are mixed to form a final bulk. It is undertaken in a large, closed vessel fitted with a stirrer and ports for the addition of constituents and withdrawal of the final blend. When bacterial vaccines are blended, the active constituents usually need to be greatly diluted and the vessel is first charged with the diluents, usually containing a preservative. Thiomersal has been widely used in the past but is now being phased out and replaced by phenoxyethanol or alternatives. A single-component final bulk is made by adding bacterial suspension, bacterial component or concentrated toxoid in such quantity that it is at the required concentration in the final product. A multiple-component final bulk of a combined vaccine is made by adding each required component in sequence. When viral vaccines are blended, the need to maintain adequate antigenicity or infectivity may preclude dilution, and tissue culture fluids, or concentrates made from them, are often used undiluted or, in the case of multicomponent vaccines, merely diluted one with another. After thorough mixing, a final bulk may be divided into a number of moderate-sized volumes to facilitate handling.

 

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