water for injection classifier
IRI: https://spec.industrialontologies.org/ontology/construct/WaterForInjectionClassifier
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: compendial grade classifier
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › denoter › classifier › material grade classifier › compendial grade classifier › water for injection classifier
Definition
compendial grade classifier that classifies a portion of water that conforms to the requirements stated in a Water for Injection pharmacopeial monograph and thus has very high purity
Explanatory Notes
1) The Water for Injection (WFI) grade is a compendial classification applied to water when conformance to an applicable WFI monograph has been demonstrated. In the European context, EMA guidance points to compliance with the European Pharmacopoeia WFI monograph. In the U.S. context, FDA inspection guidance frames WFI as a USP monograph-defined water grade. 2) In regulatory and GMP practice, WFI is best treated as a compendial-grade designation: a batch or portion of water is WFI because it meets the applicable WFI monograph requirements, and it can lose that designation if storage or distribution conditions allow microbial proliferation, endotoxin risk, or other quality risks to rise. 3) The classifier is constrained to classify water and to indicate that purity is a relevant reported quality for the classified water;
Examples
- USP Water for Injection classification of a pharmaceutical water lot; Ph. Eur. Water for Injection classification of water used in sterile drug product manufacturing; WFI classification of water supplied from a qualified pharmaceutical water system; WFI classification of water used for final formulation of an injectable drug product;
Adapted From
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmaceutical-use and https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-quality-water-pharmaceutical-use_en.pdf and https://www.cytivalifesciences.com/en/us/insights/what-is-water-for-injection
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs for creating a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
WaterForInjectionClassifier(x) → CompendialGradeClassifier(x) ∧ ∃w (PortionOfWater(w) ∧ classifies(x, w) ∧ ∃p (Purity(p) ∧ hasQuality(w, p)))
Semi-Formal Natural Language Axioms
if x is a ‘water for injection classifier’ then x is a ‘compendial grade classifier’ that ‘classifies’ some ‘portion of water’ that ‘has quality’ some ‘purity’