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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