edge of failure
IRI: https://spec.industrialontologies.org/ontology/construct/EdgeOfFailure
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › edge of failure
Definition
information content entity that describes a manufacturing process through a boundary of values of process parameters, input material attributes, or both, beyond which that process can no longer assure product quality
Explanatory Notes
1) The edge of failure marks the limit of process robustness. 2) It may correspond to a single threshold value for a parameter or to a multidimensional surface in a parameter–attribute space. 3) Edge-of-failure analysis can be performed experimentally by extending process conditions until failure occurs or by simulation of extrapolated design-space models. 4) It is a scientific and developmental concept used to understand process risk and robustness and is not essential to establishing a design space.
Examples
- In a study varying pH and temperature, the combinations of pH and temperature at which the proportion of acidic charge variants reaches its maximum acceptable value define a two-dimensional edge of failure; in a single-parameter study, the pH value at which the proportion of acidic charge variants reaches its maximum acceptable value represents a one-dimensional edge of failure
Adapted From
- https://www.biopharminternational.com/view/evaluating-design-margin-edge-failure-and-process-capability and https://www.fda.gov/media/71535/download
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
EdgeOfFailure(x) → InformationContentEntity(x) ∧ ∃p (ManufacturingProcess(p) ∧ describes(x, p)) ∧ ∃v ((InputMaterialAttribute(v) ∨ ProcessParameter(v)) ∧ isAbout(x, v))
Semi-Formal Natural Language Axioms
if x is an ‘edge of failure’ then x is an ‘information content entity’ that ‘describes’ some ‘manufacturing process’ and ‘is about’ some ‘input material attribute’ or some ‘process parameter’
Description Logic
constr:EdgeOfFailure ⊑ constr:InformationContentEntity
constr:EdgeOfFailure ⊑ ∃ constr:describes .constr:ManufacturingProcess
constr:EdgeOfFailure ⊑ ∃ constr:isAbout .(constr:InputMaterialAttribute ⊔ constr:ProcessParameter)
SubClassOf: constr:InformationContentEntity
SubClassOf: constr:describes some constr:ManufacturingProcess
SubClassOf: constr:isAbout some (constr:InputMaterialAttribute or constr:ProcessParameter)