production culture production phase

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

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

SubClass Of: manufacturing process

Class Hierarchy

owl:Thing β€Ί bfo:entity β€Ί bfo:occurrent β€Ί bfo:process β€Ί planned process β€Ί manufacturing process β€Ί production culture production phase

Definition

manufacturing process that is a temporal part of a production culture process and during which process conditions are managed primarily to support target product production

Explanatory Notes

1) A production phase is an operational window within a production culture process, not the production culture process as a whole. During this phase, process conditions are managed to support accumulation of the target product. It is distinguished from an expansion-focused part of the same process because operating decisions and process monitoring are organized around product accumulation rather than increase in cell number. 2) The word β€œphase” here does not imply that this process is prescribed by an ISA88 phase

Examples

  • production-focused window after a planned process transition; culture window managed primarily for target product production; production culture period where monitoring and control is organized around titer, productivity, viability, and product quality

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs present to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

ProductionCultureProductionPhase(x) β†’ ManufacturingProcess(x) ∧ βˆƒc (CellCulture(c) ∧ hasParticipantAtSomeTime(x, c)) ∧ βˆƒp (ProductionCultureProcess(p) ∧ temporalPartOf(x, p))

Semi-Formal Natural Language Axioms

if x is a β€˜production culture production phase’ then x is a β€˜manufacturing process’ that β€˜has participant at some time’ some β€˜cell culture’, and is a β€˜temporal part of’ some β€˜production culture process’

Description Logic


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