ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English
Deutsch
Francais

Bioburden

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

Bioburden

(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

Bioburden

The number of viable contaminating organisms per product unit.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:

Do you have a term that should be included in the glossary?
Submit a term for review

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift