specification limit value expression
IRI: https://spec.industrialontologies.org/ontology/construct/SpecificationLimitValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/
SubClass Of: acceptance limit value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › limit value expression › acceptance limit value expression › specification limit value expression
Definition
acceptance limit value expression that is part of a specification
Examples
- upper specification limit for host cell protein concentration in a drug substance; lower specification limit for protein concentration in a formulated product; upper and lower specification limits for osmolality of a process intermediate; specification limit for aggregate percentage in a monoclonal antibody product; specification limit for bioburden in a material prior to further processing
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 a set of necessary and sufficient conditions. In particular, formalization of a specification class in IOF Core is missing.
Formal Axioms
First-Order Logic Axioms
SpecificationLimitValueExpression(x) → AcceptanceLimitValueExpression(x)
Semi-Formal Natural Language Axioms
If x is a ‘specification limit value expression’ then x is an ‘acceptance limit value expression’