Define Bio burden? : Pharmaceutical Guidelines

Define Bio burden?


The level & type (i.e. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

It means the bioburden is the number microbes present in the raw material or water sample. Bioburden does not claim any specific microorganism.



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