The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, Active Pharmaceutical Ingredient (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.

In a medical device or pharmaceutical manufacturing environment, the main contributors of bioburden contamination come from personnel, raw materials, environment and water used in the manufacturing process.

Related Topics:

Antibiotic StewardshipShockDyspepsia

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