normal operating range value expression
IRI: https://spec.industrialontologies.org/ontology/construct/NormalOperatingRangeValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/
SubClass Of: range value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › range value expression › normal operating range value expression
Definition
range value expression that is an interval around a setpoint within which a particular process parameter is expected to vary during normal operation of a process and that lies within the proven acceptable range for that parameter
Explanatory Notes
NOR is the span within which a process parameter is expected to vary during normal operation. This range is distinct from broader ranges, which may include values associated with abnormal operation or alarm conditions. When a process parameter remains within its normal operating range, it is considered to be operating within its expected region of normal variability.
Examples
- 36.5–37.5 °C as the normal operating range around the setpoint 37 °C for bioreactor temperature during mammalian cell culture; 15–25 minutes as the normal operating range for residence time in a chromatography column during protein purification
Synonyms
- normal operating range
Adapted From
- https://www.fda.gov/media/179081/download and https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-improving-understanding-normal-operating-range-nor-proven-acceptable-range-par-design-space-dsp-and-normal-variability-process-parameters_en.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 necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
NormalOperatingRangeValueExpression(x) → RangeValueExpression(x) ∧ ∃z (SetpointValueExpression(z) ∧ hasContinuantPartAtAllTimes(x, z))
Semi-Formal Natural Language Axioms
if x is a ‘normal operating range value expression’ then x is a ‘range value expression’ and x ‘has continuant part at all times’ some ‘setpoint value expression’
Description Logic
constr:NormalOperatingRangeValueExpression ⊑ constr:RangeValueExpression
constr:NormalOperatingRangeValueExpression ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:SetpointValueExpression
SubClassOf: constr:RangeValueExpression
SubClassOf: bfo:has_continuant_part_at_all_times some constr:SetpointValueExpression
Provenance
- Moved from
BiopharmaParameter(https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/) on 2026-07-10T12:41:00