fed batch process operating mode

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

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

SubClass Of: planned process operating mode

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › process characteristic › planned process operating mode › fed batch process operating mode

Definition

process operating mode of a planned process in which a finite quantity of process material is introduced before or at the start of the main processing interval, and additional process material is introduced during that interval while the process material is retained and processed as a single unit

Explanatory Notes

In fed batch process operating mode, the process remains organized around a finite quantity of process material processed as a single unit, but additional process material is intentionally introduced during the main processing interval. Fed batch process operating mode should be distinguished from batch process operating mode, where additional process material is not introduced during that interval, and from continuous process operating mode, where all input materials are introduced while all the output materials are concomitantly removed during the whole processing interval. Ancillary additions such as pH adjusters, antifoam, sparging gas, buffers, wash solutions, or cleaning solutions do not by themselves make the mode fed batch.

Examples

• CHO culture with bolus glucose feeds to maintain viable cell density, harvested in a single terminal step; Semi-batch polymerization where monomer is added gradually to control heat release, then reactor is emptied;

Counter-Examples

• Simple batch bioreactor run with no feeding; Perfusion culture

Adapted From

• https://www.cytivalifesciences.com/en/us/insights/what-are-the-different-types-of-bioreactors and https://gmpua.com/Process/ContinuousManufacturing/ContinuousManufacturing.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 define a set of necessary and sufficient conditions

Formal Axioms

First-Order Logic Axioms

FedBatchProcessOperatingMode(x) → PlannedProcessOperatingMode(x) ∧ ∃p∃i∃m∃r(PlannedProcess(p) ∧ processCharacteristicOf(x,p) ∧ MaterialAdditionProcess(i) ∧ hasOccurrentPart(p,i) ∧ (ProcessIntermediateMaterial(m) ∨ RawMaterial(m)) ∧ hasInput(i,m) ∧ TransferredMaterialRole(r) ∧ hasRole(m,r))

Semi-Formal Natural Language Axioms

if x is a ‘fed batch process operating mode’ then x is a ‘planned process operating mode’ that is the ‘process characteristic of’ some ‘planned process’ that ‘has occurrent part’ some ‘material addition process’ that ‘has input’ some ‘process intermediate material’ or some ‘raw material’ that ‘has role’ some ‘transferred material role’

Description Logic

constr:FedBatchProcessOperatingMode ⊑ constr:PlannedProcessOperatingMode

constr:FedBatchProcessOperatingMode ⊑ ∃ constr:processCharacteristicOf .(constr:PlannedProcess ⊓ ∃ bfo:has_occurrent_part .(constr:MaterialAdditionProcess ⊓ ∃ constr:hasInput .((constr:ProcessIntermediateMaterial ⊔ constr:RawMaterial) ⊓ ∃ constr:hasRole .constr:TransferredMaterialRole)))

SubClassOf: constr:PlannedProcessOperatingMode

SubClassOf: constr:processCharacteristicOf some (constr:PlannedProcess and bfo:has_occurrent_part some (constr:MaterialAdditionProcess and constr:hasInput some ((constr:ProcessIntermediateMaterial or constr:RawMaterial) and constr:hasRole some constr:TransferredMaterialRole)))