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The concentration of microbial matter per unit volume. Microbial matter includes viruses, bacteria, yeast, mold, and parts thereof.
Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)
Publication Date: 2011
(ICH Q7) The level and type (e.g. 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.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
The number of viable contaminating organisms per product unit.
Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision
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