design space
IRI: https://spec.industrialontologies.org/ontology/construct/DesignSpace
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › design space
Definition
information content entity that describes a manufacturing process through a multidimensional region of combinations of values of process parameters, input material attributes, or both, within which the process assures product quality
Explanatory Notes
The design space represents the highest level of operational flexibility. Operation within the design space does not constitute a regulatory change, whereas movement outside the design space may require justification or regulatory variation. The design space is defined by process understanding and risk assessment, and may apply to a single unit operation or span multiple operations.
Examples
- During ultrafiltration, all studied combinations within a two-dimensional region defined by a transmembrane pressure of 1.5–2.5 bar and a crossflow rate of 20–30 L m⁻² h⁻¹ were demonstrated to maintain product clarity and yield
Adapted From
- https://wolfson.huji.ac.il/purification/PDF/Others/GE_DOE_in_Protein_Production_and_Purification_Handbook.pdf and https://www.biophorum.com/download/cvp-case-study-interactive-version/ and https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-improving-understanding-normal-operating-range-nor-proven-acceptable-range-par-design-space-dsp-and-normal-variability-process-parameters_en.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 create necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
DesignSpace(x) → InformationContentEntity(x) ∧ ∃p (ManufacturingProcess(p) ∧ describes(x, p)) ∧ ∃v ((InputMaterialAttribute(v) ∨ ProcessParameter(v)) ∧ isAbout(x, v))
Semi-Formal Natural Language Axioms
if x is a ‘design space’ then x is an ‘information content entity’ that ‘describes’ some ‘manufacturing process’ and ‘is about’ some ‘input material attribute’ or some ‘process parameter’
Description Logic
constr:DesignSpace ⊑ constr:InformationContentEntity
constr:DesignSpace ⊑ ∃ constr:describes .constr:ManufacturingProcess
constr:DesignSpace ⊑ ∃ constr:isAbout .(constr:InputMaterialAttribute ⊔ constr:ProcessParameter)
SubClassOf: constr:InformationContentEntity
SubClassOf: constr:describes some constr:ManufacturingProcess
SubClassOf: constr:isAbout some (constr:InputMaterialAttribute or constr:ProcessParameter)