normal operating range value expression

IRI: https://spec.industrialontologies.org/ontology/construct/NormalOperatingRangeValueExpression

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

SubClass Of: value expression

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › normal operating range value expression

Definition

value expression that is a range around a set point within which a particular process parameter is expected to vary during normal operation of a process process and that lies within the proven acceptable range for that parameter

Explanatory Notes

NOR is the span within which process is designed to function under typical conditions. This range is distinct from the broader ranges, which may include values associated with abnormal operation or alarm conditions. When a process parameter remains within the normal operating range, no alarm is expected to trigger, as the process parameter is considered to be under control.

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) → ValueExpression(x) ∧ ∃y (ProcessParameterSpecification(y) ∧ continuantPartOfAtAllTimes(x, y)) ∧ ∃z (SetpointValueExpression(z) ∧ hasContinuantPartAtAllTimes(x, z))

Semi-Formal Natural Language Axioms

if x is a ‘normal operating range value expression’ then x is a ‘value expression’ and x is a ‘continuant part of at all times’ some ‘process parameter specification’ and x ‘has continuant part at all times’ some ‘setpoint value expression’

Description Logic

constr:NormalOperatingRangeValueExpression ⊑ constr:ValueExpression

constr:NormalOperatingRangeValueExpression ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:SetpointValueExpression

constr:NormalOperatingRangeValueExpression ⊑ ∃ bfo:continuant_part_of_at_all_times .constr:ProcessParameterSpecification

SubClassOf: constr:ValueExpression

SubClassOf: bfo:has_continuant_part_at_all_times some constr:SetpointValueExpression

SubClassOf: bfo:continuant_part_of_at_all_times some constr:ProcessParameterSpecification