initial control limit value expression
IRI: https://spec.industrialontologies.org/ontology/construct/InitialControlLimitValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/TargetsLimitsRanges/
SubClass Of: control limit value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › limit value expression › control limit value expression › initial control limit value expression
Definition
control limit established from limited process data or process knowledge and applicable only until sufficient information is available to establish statistically justified control limits
Explanatory Notes
An initial (provisional) control limit is used at the start of continued process verification or after process changes when process history is still limited. It provides monitored boundaries for continued manufacturing while additional data are collected to confirm process stability and variability. Once adequate data are available, the initial control limits are replaced by control limits that represent the long-term state of control.
Examples
- After installing a new sparger system, dissolved oxygen is monitored using initial control limits of 33 %–47 %, pending evaluation of additional process data to establish long-term control limits; during the first 10 batches after scale-up, temperature is monitored using initial control limits of 36–38 °C until sufficient data are available to establish statistically justified control limits
Synonyms
- initial control limit
- provisional control limit
Adapted From
- https://www.biophorum.com/download/cvp-case-study-interactive-version/
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
This term is expected to remain primitive as it is not expected that a formalization of sufficient information will be available that can fit all use cases.
Formal Axioms
First-Order Logic Axioms
InitialControlLimitValueExpression(x) → ControlLimitValueExpression(x)
Semi-Formal Natural Language Axioms
If x is an ‘initial control limit value expression’ then x is a ‘control limit value expression’