atline monitoring process

IRI: https://spec.industrialontologies.org/ontology/construct/AtlineMonitoringProcess

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/

SubClass Of: monitoring process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › monitoring process › atline monitoring process

Definition

monitoring process consisting of one or more measurement processes that are preceded by a material sampling process, in which material representing the entity of interest is collected from a process stream or in-process material and transferred to analytical equipment located within the same physical area

Explanatory Notes

1) The measurement is performed using analytical equipment located in a physical area that environs a planned process during which the material sampling process occurs. That planned process provides the spatial reference and is not thereby asserted to be the entity being monitored. 2) At-line monitoring differs from on-line monitoring because on-line material sampling and measurement occur through analytical equipment connected by a material-transfer arrangement to process equipment, whereas an at-line material sample is brought to separate analytical equipment. 3) FDA PAT describes at-line measurement as analysis in close proximity to the process stream. In this ontology, the physical area that environs the planned process provides the governed operational boundary for that proximity.

Examples

• Monitoring cell viability and concentration by measuring a freshly withdrawn bioreactor sample using a local analyzer within the same cleanroom suite

Adapted From

• https://www.hamiltoncompany.com/knowledge-base/article/bioprocess-monitoring-and-control?srsltid=AfmBOopxhhPv6WbMS7X9JSrLqEcmh6O53_Ap2y2HugM4ZBwyhECSjEa-

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

AtlineMonitoringProcess(x) → MonitoringProcess(x) ∧ ∃s∃t∃m∃a∃r∃p (MaterialSamplingProcess(s) ∧ MaterialLocationChangeProcess(t) ∧ MeasurementProcess(m) ∧ MaterialSample(a) ∧ PhysicalArea(r) ∧ PlannedProcess(p) ∧ hasOccurrentPart(x, s) ∧ hasOccurrentPart(x, t) ∧ hasOccurrentPart(x, m) ∧ occurrentPartOf(s, p) ∧ hasSpecifiedOutput(s, a) ∧ hasParticipantAtAllTimes(t, a) ∧ hasInput(m, a) ∧ precedes(s, t) ∧ precedes(t, m) ∧ occursIn(m, r) ∧ environs(r, p))

Semi-Formal Natural Language Axioms

if x is an ‘atline monitoring process’ then x is a ‘monitoring process’ that has occurrent parts including a ‘material sampling process’ s, a ‘material location change process’ t, and a ‘measurement process’ m, and s is an ‘occurrent part of’ some ‘planned process’ p, and s ‘has specified output’ some ‘material sample’ a that t ‘has participant at all times’ and that is an ‘input’ of m, and s ‘precedes’ t, t ‘precedes’ m, and m ‘occurs in’ some ‘physical area’ r that ‘environs’ p

Description Logic

constr:AtlineMonitoringProcess ⊑ constr:MonitoringProcess

constr:AtlineMonitoringProcess ⊑ ∃ bfo:has_occurrent_part .(constr:MaterialSamplingProcess ⊓ ∃ bfo:precedes .(constr:MaterialLocationChangeProcess ⊓ ∃ bfo:precedes .(constr:MeasurementProcess ⊓ ∃ bfo:occurs_in .(constr:PhysicalArea ⊓ ∃ bfo:environs .constr:PlannedProcess) ⊓ ∃ constr:hasInput .constr:MaterialSample) ⊓ ∃ bfo:has_participant_at_all_times .constr:MaterialSample) ⊓ ∃ constr:hasSpecifiedOutput .constr:MaterialSample)

constr:AtlineMonitoringProcess ⊓ constr:InlineMonitoringProcess ⊑ ⊥

constr:AtlineMonitoringProcess ⊓ constr:OfflineMonitoringProcess ⊑ ⊥

constr:AtlineMonitoringProcess ⊓ constr:OnlineMonitoringProcess ⊑ ⊥

SubClassOf: constr:MonitoringProcess

SubClassOf: bfo:has_occurrent_part some (constr:MaterialSamplingProcess and bfo:precedes some (constr:MaterialLocationChangeProcess and bfo:precedes some (constr:MeasurementProcess and bfo:occurs_in some (constr:PhysicalArea and bfo:environs some constr:PlannedProcess) and constr:hasInput some constr:MaterialSample) and bfo:has_participant_at_all_times some constr:MaterialSample) and constr:hasSpecifiedOutput some constr:MaterialSample)

constr:AtlineMonitoringProcess DisjointWith: (constr:InlineMonitoringProcess, constr:OfflineMonitoringProcess, constr:OnlineMonitoringProcess)