process parameter specification

IRI: https://spec.industrialontologies.org/ontology/construct/ProcessParameterSpecification

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

SubClass Of: information content entity

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › process parameter specification

Direct subclasses:

Definition

information content entity that prescribes a monitorable or controllable variable associated with some planned process

Explanatory Notes

1) Process parameters must be defined with its target value or acceptable range. A process parameter may be critical or non-critical. 2) Ranges for process parameters are established during process development, and changes to operating ranges will be managed within the quality system. 3) Process parameters are used to describe and control the conditions under which a process operates, ensuring that the process achieves its intended results. 4) Process parameters are essential for defining how a process should be carried out and are typically specified in process documentation or recipes. They provide the necessary details for operators and control systems to maintain the process within desired conditions, supporting consistent product quality and process performance.

Usage Notes

Process parameter specifications are used to prescribe process parameters, which may take the form of process profiles, qualities, or temporal regions. Process profiles may reflect the realization of capabilities inhering in equipment or consumables, such as the agitation speed of an impeller, or describe dynamic properties of participating entities, such as the flow rate of a fluid stream or the sampling frequency in a monitoring subprocess. Temporal parameters, such as incubation time or residence time, are modeled as temporal regions that represent the duration or timing of a process or subprocess. Qualities refer to intrinsic characteristics of process participants, such as temperature, pH, pressure, or concentration, which are constrained or controlled during the process. When prescribed by a specification, these qualities represent targeted or acceptable ranges of measurable features during the process. The axiom that a process parameter specification must prescribe some temporal region, process profile, or quality formally captures the scope of what qualifies as a process parameter.

Examples

  • agitation speed specification for the mixing process in a cell culture step; incubation time specification for the cell expansion process; temperature specification for the fermentation process; flow rate specification for the loading phase of a chromatography process; pH specification for the neutralization process in buffer preparation; and residence time specification for the viral inactivation process

Counter-Examples

  • a material specification for a raw material, which defines material properties rather than process behavior; and a specification stating the amount of glucose to be added to a bioreactor, which is an input specification describing material inputs rather than a process parameter; model number of a chromatography column or chromatography type (affinity)

Adapted From

  • https://www.biophorum.com/wp-content/uploads/bp_downloads/CPV-Case-Study-Interactive-Version.pdf; https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-manufacture-finished-dosage-form-revision-1_en.pdf and ISA88

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 monitorable and controlable.

Formal Axioms

First-Order Logic Axioms 

ProcessParameterSpecification(x) → InformationContentEntity(x) ∧ ∃y (PlanSpecification(y) ∧ continuantPartOfAtAllTimes(x, y)) ∧ ∃z ((TemporalRegion(z) ∨ ProcessProfile(z) ∨ Quality(z)) ∧ prescribes(x, z))

Semi-Formal Natural Language Axioms

if x is a ‘process parameter specification’ then x is an ‘information content entity’ and x is a ‘continuant part of at all times’ some ‘plan specification’ and x ‘prescribes’ some ‘temporal region’ or ‘process profile’ or ‘quality’

Description Logic

constr:ProcessParameterSpecification ⊑ constr:InformationContentEntity

constr:ProcessParameterSpecification ⊑ ∃ bfo:continuant_part_of_at_all_times .constr:PlanSpecification

constr:ProcessParameterSpecification ⊑ ∃ constr:prescribes .(bfo:temporal_region ⊔ bfo:quality ⊔ bfo:process_profile)

constr:ProcessParameterSpecification ⊓ constr:QualityAttributeSpecification ⊑ ⊥

SubClassOf: constr:InformationContentEntity

SubClassOf: bfo:continuant_part_of_at_all_times some constr:PlanSpecification

SubClassOf: constr:prescribes some (bfo:temporal_region or bfo:quality or bfo:process_profile)

constr:ProcessParameterSpecification DisjointWith: constr:QualityAttributeSpecification