contaminant role
IRI: https://spec.industrialontologies.org/ontology/construct/ContaminantRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: material impurity role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › contaminant role
Definition
material impurity role held by a material entity when it is adventitiously introduced during a manufacturing process
Explanatory Notes
1) Manufacturing contaminants are adventitiously introduced materials that were not intended to be present in the manufacturing process, and in biopharmaceutical manufacturing they include chemical or biochemical materials (e.g., microbial proteases) and microbial species. 2) This role is intended to distinguish contaminants from process-associated impurities that arise from planned or inherent aspects of executing the intended process. 3) Regulators expect manufacturing programs to prioritize avoidance, or controlled removal to meet drug substance or drug product specifications, using appropriate in-process acceptance criteria or measurable action thresholds for the affected material stream, while recognizing that adventitious viral or mycoplasma contamination is not managed by allowable-range action limits, and instead requires control strategies guided by dedicated ICH viral-safety and cell-substrate characterization guidance, as part of validated contamination-prevention or mitigation safeguards
Examples
- the contaminant role of mycoplasma adventitiously introduced into a mammalian cell culture; the contaminant role of an adventitious virus introduced through contaminated biological raw material; the contaminant role of bacterial cells introduced into a buffer preparation during manufacturing; the contaminant role of environmental particulate matter introduced during an open handling step of a manufacturing process
Adapted From
- https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
ContaminantRole(x) → MaterialImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is a ‘contaminant role’ then x is a ‘material impurity role’