expired 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 state
Definition
material state during which the participating material entity is no longer qualified to 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. Once the established expiry, use, or lifecycle limit has been exceeded, the material entity does not return to its qualified state 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 should not be confused with a state associated with a best-before date, which is typically used where deterioration in quality may occur without necessarily making the material unsuitable or unsafe for use. Concepts associated with best-before dating should be modeled separately. 4) The first instant of the expired state corresponds to the point at which the material entity is no longer qualified to realize its specified capability. This point may be established in advance based on stability studies, predefined shelf life, validated use limits, 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 is no longer qualified to realize its specified capability for use as a vaccine, 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 is no longer qualified to 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 a set of necessary and sufficient conditions.
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