extractable and leachable impurity role
IRI: https://spec.industrialontologies.org/ontology/construct/ExtractableAndLeachableImpurityRole
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: material impurity role
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:specifically dependent continuant › bfo:realizable entity › bfo:role › material impurity role › extractable and leachable impurity role
Definition
material impurity role held by a material entity in virtue of that material entity being present in a target material as a result of transfer from an artifact that contacts the target material
Explanatory Notes
1) This role groups cases commonly termed extractables and leachables: Extractables: material entities intentionally extracted from manufacturing components/systems, packaging components, or delivery device components under specified laboratory test conditions; often treated as potential leachables for a given target material and use scenario. Leachables: material entities that migrate from manufacturing components/systems, packaging components, or delivery device components into a target material under established conditions of manufacture and/or labeled storage conditions (or, more generally, established handling/transport/use conditions). 2) “Artifact that contacts the target material” includes, for example, containers/closures, bags, tubing, filters, seals/gaskets, connectors, pumps, and relevant equipment surfaces.
Examples
- the extractable and leachable impurity role of a plasticizer extracted from single-use tubing during an extractables study; the extractable and leachable impurity role of an antioxidant degradation product leached from a polymer bag into a process intermediate; the extractable and leachable impurity role of silicone oil transferred from a syringe component into a drug product; the extractable and leachable impurity role of a rubber stopper-derived compound detected in a filled vial during storage;
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-q3e-guideline-extractables-leachables_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
ExtractableAndLeachableImpurityRole(x) → MaterialImpurityRole(x)
Semi-Formal Natural Language Axioms
if x is an ‘extractable and leachable impurity role’ then x is a ‘material impurity role’