material performance testing process
IRI: https://spec.industrialontologies.org/ontology/construct/MaterialPerformanceTestingProcess
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 performance testing process
Definition
material testing process that evaluates a capability of the input material entity through its use in a specified process or its exposure to specified test conditions
Explanatory Notes
The assertion that an input material entity has the capability evaluated by a material performance testing process does not imply that the capability is adequate for the intended application or that the material meets the applicable performance criteria. The testing may produce a favorable, unfavorable, or inconclusive assessment of the capability.
Examples
- small-scale performance testing of a culture-medium lot by preparing the medium according to a specified procedure, using it in a controlled mammalian cell-culture process, and evaluating viable cell density, viability, growth rate, and product titer against specified performance criteria; performance testing of a chromatography-resin lot by packing the resin into a small-scale column, operating it under specified loading, washing, and elution conditions, and evaluating dynamic binding capacity, product recovery, impurity clearance, and pressure-flow behavior against specified performance criteria
Adapted From
- https://database.ich.org/sites/default/files/Q7%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 a set of necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
MaterialPerformanceTestingProcess(x) → MaterialTestingProcess(x) ∧ ∃m∃c∃t(MaterialEntity(m) ∧ hasInput(x,m) ∧ Capability(c) ∧ hasCapability(m,c) ∧ MaterialTestingInformationContentEntity(t) ∧ hasSpecifiedOutput(x,t) ∧ describes(t,c))
Semi-Formal Natural Language Axioms
if x is a ‘material performance testing process’ then x is a ‘material testing process’ that ‘has input’ some ‘material entity’ that ‘has capability’ some ‘capability’ and ‘has specified output’ some ‘material testing information content entity’ that ‘describes’ that ‘capability’
Description Logic
constr:MaterialPerformanceTestingProcess ⊑ constr:MaterialTestingProcess
constr:MaterialPerformanceTestingProcess ⊑ ∃ constr:hasInput .(bfo:material_entity ⊓ ∃ constr:hasCapability .constr:Capability)
constr:MaterialPerformanceTestingProcess ⊑ ∃ constr:hasSpecifiedOutput .(constr:MaterialTestingInformationContentEntity ⊓ ∃ constr:describes .constr:Capability)
SubClassOf: constr:MaterialTestingProcess
SubClassOf: constr:hasInput some (bfo:material_entity and constr:hasCapability some constr:Capability)
SubClassOf: constr:hasSpecifiedOutput some (constr:MaterialTestingInformationContentEntity and constr:describes some constr:Capability)