key process parameter specification
IRI: https://spec.industrialontologies.org/ontology/construct/KeyProcessParameterSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: process parameter specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › process parameter specification › key process parameter specification
Definition
process parameter specification that prescribes a variable which must be tightly controlled to ensure process consistency and that does not directly impact any critical quality attribute
Examples
- temperature specification for media hold, which is necessary to prevent microbial growth without affecting downstream CQAs; flow rate specification for diafiltration buffer addition, important for maintaining steady-state conditions but not directly impacting product purity;
Adapted From
- https://www.biophorum.com/wp-content/uploads/bp_downloads/CPV-Case-Study-Interactive-Version.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
KeyProcessParameterSpecification(x) → ProcessParameterSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘key process parameter specification’ then x is a ‘process parameter specification’