action limit value expression
IRI: https://spec.industrialontologies.org/ontology/construct/ActionLimitValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/
SubClass Of: limit value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › limit value expression › action limit value expression
Definition
limit value expression beyond which action is required to address a departure from normal operating conditions and prevent or mitigate potential impact on process performance or product quality
Explanatory Notes
1) Exceeding an action limit requires the response prescribed for that limit. Depending on the application, this may include process adjustment, investigation, deviation or nonconformance handling, assessment of potential impact, and corrective or preventive action. 2) Action limits are part of the internal process control framework and are not regulatory reporting limits.
Examples
- Chromatography column pressure has a normal operating range with an upper boundary of 1.5 bar and an action limit of 2.0 bar. A pressure value beyond 2.0 bar requires action to address potential fouling or blockage and prevent column damage or product loss; dissolved oxygen in a bioreactor has a setpoint of 40 % air saturation, a normal operating range of 35–45 %, a lower action limit of 30 %, and an upper action limit of 50 %. Crossing either action limit requires action to restore dissolved oxygen to normal operating conditions and prevent impact on cell culture performance
Synonyms
- action limit
Adapted From
- https://www.biophorum.com/download/cvp-case-study-interactive-version/ and https://www.thermofisher.com/rs/en/home/industrial/microbiology/pharmaceutical-microbiology/environmental-monitoring/applications.html and https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.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
ActionLimitValueExpression(x) → LimitValueExpression(x)
Semi-Formal Natural Language Axioms
If x is an ‘action limit value expression’ then x is a ‘limit value expression’