batch process operating mode
IRI: https://spec.industrialontologies.org/ontology/construct/BatchProcessOperatingMode
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 › 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 processed as a single unit, without additional process material being introduced or removed during that interval
Explanatory Notes
In batch process operating mode, a finite quantity of process material is processed as a single unit. The defining feature is that the process material is introduced before or at the start of the main processing interval and is not supplemented by additional process material during that interval. This does not exclude sampling, gas exchange, venting, minor control additions, or other ancillary operations that do not change the batch mode character of the process. Batch process operating mode should be distinguished from fed batch process operating mode, where additional process material is intentionally introduced during the run, and from continuous process operating mode, where material is introduced while output material is concomitantly removed over an operating interval.
Examples
- batch process operating mode of Protein A capture chromatography with a finite clarified-harvest load processed as a single unit to generate a product pool; batch process operating mode of mammalian cell culture in which process material is introduced before or at the start of cultivation and processed as a single unit without additional process material addition during cultivation; batch process operating mode of API crystallization in which a finite solvent/solute quantity is processed as a single unit before solids recovery
Adapted From
- https://www.cytivalifesciences.com/en/us/news-center/what-are-the-different-bioreactor-processes-10001 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
BatchProcessOperatingMode(x) → PlannedProcessOperatingMode(x)
Semi-Formal Natural Language Axioms
if x is a ‘batch process operating mode’ then x is a ‘planned process operating mode’