expired material state
IRI: https://spec.industrialontologies.org/ontology/construct/ExpiredState
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterialProcurementAndStorage/
SubClass Of: material state
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › material state › expired material state
Definition
material state during which the participating material entity can no longer realize a particular specified capability and that temporally ends with the destruction or disposal of the material entity.
Explanatory Notes
1) The expired state ends only with the end of the material entity’s lifecycle, since the material entity cannot regain the lost capability. This state is considered terminal with respect to the function or disposition that has ceased, and no restoration to the original functional condition is possible under normal or intended circumstances. 2) A specified capability refers to a capability that the material entity is intended designed, or qualified to realize, as defined by product design, quality specification, regulatory requirement, or intended use. 3) Expired state does not correlate with the best before date which is applied to cases (typically food industry) where an items capability may only deteriorate slightly , and is thus are unlikely to become dangerous as a result. The notions sorrounding best before should be modeled separately from this term. 4) The first instant of the expired state corresponds to the point in time when the material entity is no longer capable of realizing its specified capability. This point is typically predicted or determined in advance based on stability studies, predefined shelf life, or other empirical criteria, and may be documented through quality specifications, labeling, or regulatory filings.
Examples
- The state of a vaccine vial starting from its expiration date, during which it can no longer realize the capability to elicit an immune response, and which ends when the vial is discarded as biological waste; The state of a prepacked chromatography column beginning after it exceeds its validated number of separation cycles, during which it can no longer realize its specified separation capability, and which ends when the column is discarded
Counter-Examples
- The state of a chromatography column that temporarily fails performance specifications but is undergoing regeneration for reuse.
Adapted From
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to represent the association between the state and the capability not being realizable during the duration of the state
Formal Axioms
First-Order Logic Axioms
ExpiredState(x) → MaterialState(x)
Semi-Formal Natural Language Axioms
If x is an ‘expired state’, then x is a ‘material state’.
Description Logic
SubClassOf: constr:MaterialState