sterile material state
IRI: https://spec.industrialontologies.org/ontology/construct/SterileMaterialState
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingExecution/
SubClass Of: material state
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › material state › sterile material state
Definition
material state in which a participating material entity is free of viable microorganisms
Explanatory Notes
sterile material state applies to a material entity when the relevant condition that remains unchanged is that the material entity is free of viable microorganisms. It may apply to process materials, vessels, equipment parts, containers, closures, filters, tubing assemblies, fluid pathways, or other product-contact materials expected to remain sterile. In regulated manufacturing contexts, sterile status is typically established through validated sterilization or aseptic processing controls and sterility assurance, rather than by direct demonstration of the absence of every viable microorganism. Sterile material state should be distinguished from clean state or disinfected state, which may involve reduction or removal of bioburden without necessarily rendering the material entity free of viable microorganisms.
Examples
- the sterile material state of culture medium after filtration through a sterilizing-grade membrane filter; the sterile material state of a stainless-steel bioreactor vessel after steam sterilization; the sterile material state of glassware after autoclaving;
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 represent absence of viable microorganisms
Formal Axioms
First-Order Logic Axioms
SterileMaterialState(x) → MaterialState(x)
Semi-Formal Natural Language Axioms
if x is a ‘sterile material state’ then x is a ‘material state’