proven acceptable range value expression
IRI: https://spec.industrialontologies.org/ontology/construct/ProvenAcceptableRangeValueExpression
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 › proven acceptable range value expression
Definition
value expression range that has been validated through testing or documented experience and that is a prescribed range 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 it is typically narrower than the full instrument span. It defines the boundaries for making saleable product, and excursions outside this range are considered process deviations that may require investigation and 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) → ValueExpression(x) ∧ ∃y (ProcessParameterSpecification(y) ∧ continuantPartOfAtAllTimes(x, y))
Semi-Formal Natural Language Axioms
if x is a ‘proven acceptable range value expression’ then x is a ‘value expression’ and x is a ‘continuant part of at all times’ some ‘process parameter specification’
Description Logic
constr:ProvenAcceptableRangeValueExpression ⊑ constr:ValueExpression
constr:ProvenAcceptableRangeValueExpression ⊑ ∃ bfo:continuant_part_of_at_all_times .constr:ProcessParameterSpecification
SubClassOf: constr:ValueExpression
SubClassOf: bfo:continuant_part_of_at_all_times some constr:ProcessParameterSpecification