splitting process
IRI: https://spec.industrialontologies.org/ontology/construct/SplittingProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: manufacturing process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › manufacturing process › splitting process
Definition
manufacturing process in which a batch or lot of a product or intermediate is divided into two or more separately managed portions for further processing, handling, storage or release
Explanatory Notes
1) This process is typically employed to create distinct manufacturing portions from a parent batch or lot for subsequent manufacturing activities. 2) The resulting portions remain traceable to the original parent batch or lot and are managed as distinct portions in further manufacturing. 3) Not to be confused with sampling or aliquoting, where material is subdivided solely for analytical, testing, or measurement purposes rather than to establish distinct manufacturing portions.
Examples
- An intermediate seed culture lot is divided into multiple separately managed portions for further parallel seed expansion; A bulk drug substance lot is divided into multiple separately managed portions for parallel processing; monoclonal antibody manufacturing process produces a single harvested intermediate batch that is divided into three separately managed portions for further downstream purification
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
This term is expected to remain primitive as formalization in OWL requires cardinality constraints.
Formal Axioms
First-Order Logic Axioms
SplittingProcess(x) → ManufacturingProcess(x) ∧ ∃i ((MaterialProduct(i) ∨ ProcessIntermediateMaterial(i)) ∧ hasInput(x, i)) ∧ ∃o1 ∃o2 (MaterialEntity(o1) ∧ MaterialEntity(o2) ∧ hasSpecifiedOutput(x, o1) ∧ hasSpecifiedOutput(x, o2) ∧ o1 ≠ o2)
Semi-Formal Natural Language Axioms
if x is a ‘splitting process’ then x is a ‘manufacturing process’ that ‘has input’ some ‘material product’ or some ‘process intermediate material’, and ‘has specified output’ at least two ‘material entities’
Description Logic
constr:SplittingProcess ⊑ constr:ManufacturingProcess
constr:SplittingProcess ⊑ ∃ constr:hasInput .(constr:MaterialProduct ⊔ constr:ProcessIntermediateMaterial)
constr:SplittingProcess ⊑ ∃ constr:hasSpecifiedOutput .bfo:material_entity
SubClassOf: constr:ManufacturingProcess
SubClassOf: constr:hasInput some (constr:MaterialProduct or constr:ProcessIntermediateMaterial)
SubClassOf: constr:hasSpecifiedOutput some bfo:material_entity