bioburden
- Guideline or reference source
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- The level and type (e.g. objectionable or not) of micro-organisms 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.
- Related Term
- contamination
- decontamination
- disinfection
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