material impurity role

IRI: https://spec.industrialontologies.org/ontology/construct/MaterialImpurityRole

Defined In: https://spec.industrialontologies.org/ontology/biopharma/ReferenceOntologyCandidates/

SubClass Of: bfo:role

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role

Direct subclasses:

• contaminant role
• extractable and leachable impurity role
• manufacturing process related impurity role
• pharmaceutical product related impurity role

Definition

role of a material entity that is present within a process intermediate material, raw material, production consumable, or material product and that is not included in the material composition defined for the relevant stage of manufacture, handling, storage, or release

Explanatory Notes

1) A material entity bearing a material impurity role is a non-target constituent in the material entity it is a part of arising from manufacturing, storage, handling, or use. 2) In pharmaceutical manufacturing, impurities are controlled because their presence or amount may affect product quality, safety, efficacy, or stability. Acceptable levels may be established as part of the control strategy based on the known or potential impact of the impurity, available qualification data, and the capability of the manufacturing process to control its formation or removal. An impurity may be progressively reduced or cleared across multiple manufacturing steps rather than controlled by a limit at every intermediate stage. 3) Bearing material impurity role does not imply that the impurity exceeds an acceptance criterion.

Examples

• material impurity role of residual solvent remaining after synthesis; material impurity role of oxidation product formed during storage of a biologic; material impurity role of a trace contaminant present in a raw material lot

Adapted From

• http://purl.allotrope.org/ontologies/role#AFRL_0000364 and http://purl.obolibrary.org/obo/CHEBI_143130 and 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. In particular all the constructs necessary for representing not being a defined or specified part of the entity in question are missing

Formal Axioms

First-Order Logic Axioms

MaterialImpurityRole(x) → Role(x) ∧ ∃a∃b(roleOf(x,a) ∧ MaterialEntity(a) ∧ continuantPartOfAtSomeTime(a,b) ∧ (MaterialProduct(b) ∨ ProcessIntermediateMaterial(b) ∨ ProductionConsumable(b) ∨ RawMaterial(b)))

Semi-Formal Natural Language Axioms

if x is a ‘material impurity role’ then x is a ‘role’ that is the ‘role of’ some ‘material entity’ that is a ‘continuant part of at some time’ some ‘material product’, ‘process intermediate material’, ‘production consumable’, or ‘raw material’

Description Logic

constr:MaterialImpurityRole ⊑ bfo:role

constr:MaterialImpurityRole ⊑ ∃ constr:roleOf .(bfo:material_entity ⊓ ∃ bfo:continuant_part_of_at_some_time .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial ⊔ constr:ProductionConsumable ⊔ constr:RawMaterial))

SubClassOf: bfo:role

SubClassOf: constr:roleOf some (bfo:material_entity and bfo:continuant_part_of_at_some_time some (constr:MaterialProduct or constr:ProcessIntermediateMaterial or constr:ProductionConsumable or constr:RawMaterial))