process excursion
IRI: https://spec.industrialontologies.org/ontology/construct/ProcessExcursion
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
SubClass Of: event
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › event › process excursion
Definition
event in which the value of a variable monitored during a planned process is beyond a predefined limit or outside a predefined range during that process
Explanatory Notes
A process excursion may or may not constitute a deviation event. Whether a process excursion constitutes a deviation event depends on the applicable plan, specification, limit, range, procedure, or other requirement.
Examples
- temperature excursion during a cell culture process when the monitored temperature exceeds the action limit; pH excursion during buffer preparation when the measured pH is outside the approved range; dissolved oxygen excursion during bioreactor operation when the monitored value falls below the control limit; conductivity excursion during chromatography when the monitored conductivity is outside the specified range
Adapted From
- https://www.biopharminternational.com/view/monitoring-biopharmaceutical-processes-present-and-future-approaches and https://insideautomation.net/workflow-for-biopharmaceutical-excursions/ and https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Points_to_Consider_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 a set of necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
ProcessExcursion(x) → Event(x) ∧ ∃p (occurrentPartOf(x, p) ∧ PlannedProcess(p) ∧ ∃m (hasOccurrentPart(p, m) ∧ MonitoringProcess(m)))
Semi-Formal Natural Language Axioms
if x is a ‘process excursion’ then x is an ‘event’ and x is an ‘occurrent part of’ some ‘planned process’ that ‘has occurrent part’ some ‘monitoring process’
Description Logic
constr:ProcessExcursion ⊑ constr:Event
constr:ProcessExcursion ⊑ ∃ bfo:occurrent_part_of .(constr:PlannedProcess ⊓ ∃ bfo:has_occurrent_part .constr:MonitoringProcess)
SubClassOf: constr:Event
SubClassOf: bfo:occurrent_part_of some (constr:PlannedProcess and bfo:has_occurrent_part some constr:MonitoringProcess)