bioburden
IRI: https://spec.industrialontologies.org/ontology/construct/Bioburden
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: bfo:relational quality
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:quality › bfo:relational quality › bioburden
Definition
relational quality of a material entity that is the extent to which viable microorganisms are present in or on the surface of the material entity
Explanatory Notes
1) In sterilization and aseptic processing contexts, bioburden is commonly assessed prior to a sterilization or other microbicidal process and is used to characterize the microbial challenge presented to that process 2) This quality refers only to viable microorganisms such as bacteria, yeast, or mold present within or on a material entity. It excludes viruses, endotoxins, and non-viable biological matter, which are represented by separate quality attributes.
Examples
- the bioburden of a raw material lot before use in manufacturing; the bioburden of a process intermediate before sterile filtration; the bioburden of equipment surfaces after cleaning; the bioburden of a water sample from a water system; the bioburden of a packaging component before sterilization
Adapted From
- https://www.sigmaaldrich.com/US/en/applications/microbiological-testing/bioburden-testing?srsltid=AfmBOooIv6z3mhn24wCBPWkNZ1d0tqxlOup_y_ and https://www.biophorum.com/download/cvp-case-study-interactive-version/
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs for creating a set of necessary and sufficient conditions. In particular located on is still missing
Formal Axioms
First-Order Logic Axioms
Bioburden(x) → RelationalQuality(x) ∧ ∃m (MaterialEntity(m) ∧ qualityOf(x, m))
Semi-Formal Natural Language Axioms
if x is a ‘bioburden’ then x is a ‘relational quality’ that is the ‘quality of’ some ‘material entity’
Description Logic
constr:Bioburden ⊑ bfo:relational_quality
SubClassOf: bfo:relational_quality