material stability testing process

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

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

SubClass Of: material testing process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › material testing process › material stability testing process

Definition

material testing process that evaluates the capability of an input material entity to maintain one or more specified attributes or performance characteristics over time under specified conditions

Examples

• stability testing of a drug substance batch after refrigerated storage to determine whether purity, potency, and appearance remain within specified stability criteria; stability testing of a formulated drug product after storage at long-term and accelerated conditions to determine whether assay, degradation products, pH, and visible particles remain within specified criteria; stability testing of a cell culture medium lot after storage at 2–8 °C to determine whether pH, osmolality, appearance, and key nutrient concentrations remain within specified limits;

Adapted From

• https://database.ich.org/sites/default/files/Q1A%28R2%29%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 present to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

MaterialStabilityTestingProcess(x) → MaterialTestingProcess(x) ∧ ∃m∃s∃o(MaterialEntity(m) ∧ hasInput(x,m) ∧ Stability(s) ∧ hasCapability(m,s) ∧ MaterialTestingInformationContentEntity(o) ∧ hasSpecifiedOutput(x,o) ∧ describes(o,s))

Semi-Formal Natural Language Axioms

if x is a ‘material stability testing process’ then x is a ‘material testing process’ that ‘has input’ some ‘material entity’ m that ‘has capability’ some ‘stability’ s and ‘has specified output’ some ‘material testing information content entity’ that ‘describes’ that same ‘stability’ s

Description Logic

constr:MaterialStabilityTestingProcess ⊑ constr:MaterialTestingProcess

constr:MaterialStabilityTestingProcess ⊑ ∃ constr:hasInput .(bfo:material_entity ⊓ ∃ constr:hasCapability .constr:Stability)

constr:MaterialStabilityTestingProcess ⊑ ∃ constr:hasSpecifiedOutput .(constr:MaterialTestingInformationContentEntity ⊓ ∃ constr:describes .constr:Stability)

SubClassOf: constr:MaterialTestingProcess

SubClassOf: constr:hasInput some (bfo:material_entity and constr:hasCapability some constr:Stability)

SubClassOf: constr:hasSpecifiedOutput some (constr:MaterialTestingInformationContentEntity and constr:describes some constr:Stability)