sterilization process
IRI: https://spec.industrialontologies.org/ontology/construct/SterilizationProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › sterilization process
Definition
planned process in which a material entity is rendered free of all viable microorganisms
Examples
- steam sterilization of stainless-steel bioreactor vessel prior to culture; autoclave sterilization of glassware and stainless-steel fittings used in upstream processing; filtration sterilization of culture medium through 0.22 µm membrane filter before inoculation; gamma irradiation of single-use tubing assemblies prior to installation
Adapted From
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-format-premarket-notification-510k-submissions-liquid-chemical-sterilantshigh-level
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 a set of necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
SterilizationProcess(x) → PlannedProcess(x) ∧ ∃m ∃s (MaterialEntity(m) ∧ hasInput(x, m) ∧ SterileMaterialState(s) ∧ hasPostMaterialState(x, s) ∧ hasMaterialState(m, s))
Semi-Formal Natural Language Axioms
if x is a ‘sterilization process’ then x is a ‘planned process’ that ‘has input’ some ‘material entity’ that ‘has material state’ some ‘sterile material state’ that is also the ‘post material state’ of x
Description Logic
constr:SterilizationProcess ⊑ constr:PlannedProcess
constr:SterilizationProcess ⊑ ∃ constr:hasInput .bfo:material_entity
constr:SterilizationProcess ⊑ ∃ constr:hasPostMaterialState .constr:SterileMaterialState
SubClassOf: constr:PlannedProcess
SubClassOf: constr:hasInput some bfo:material_entity
SubClassOf: constr:hasPostMaterialState some constr:SterileMaterialState