proven acceptable range value expression
IRI: https://spec.industrialontologies.org/ontology/construct/ProvenAcceptableRangeValueExpression
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 › proven acceptable range value expression
Definition
range value expression that has been validated through testing or documented experience and that is a prescribed interval within which a single process parameter may vary without adversely affecting product quality, assuming all other process parameters are held constant at their target values
Explanatory Notes
The PAR is established based on process development and validation activities and is typically narrower than the full instrument operating span. It defines the demonstrated boundaries for acceptable operation of the process parameter, and excursions outside this range may be treated as process deviations requiring assessment, investigation, or corrective action.
Examples
- 35.0–38.0 °C as the proven acceptable range for bioreactor temperature during mammalian cell culture; pH 6.5–7.5 as the proven acceptable range for culture medium pH during fermentation
Synonyms
- proven acceptable range
Adapted From
- https://www.fda.gov/media/71535/download (Guidance for Industry Q8 R2 Development)
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
ProvenAcceptableRangeValueExpression(x) → RangeValueExpression(x)
Semi-Formal Natural Language Axioms
if x is a ‘proven acceptable range value expression’ then x is a ‘range value expression’
Description Logic
SubClassOf: constr:RangeValueExpression
Provenance
- Moved from
BiopharmaParameter(https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/) on 2026-07-10T12:41:00