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