Process Analytical Technology (PAT) A System for-
• Designing,
• Analyzing &
• Controlling Manufacturing through Timely Measurements (i.e., during processing) of Critical Quality and Performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.
There are main 3 phases for implementation of PAT System:
Phase 1 : Designing Phase
After Risk Identification, High Risk Critical Factors, i.e. risks identified as CMAs & CPPs, are optimized with respect to CQAs through QbD at Lab Scale Developmental level with AT LINE / OFF LINE Analyzers for Prediction of Real Time Data & then Control Strategies for each CMAs & CPPs are proposed for Commercial Scale by:
1. Designing of Experiments (RSM)
2. Evaluation of Regression Model Statistics
3. Development of Design Space
4. Proposal of Control Space
Phase 2 : Analyzing Phase
In Analyzing Phase, Real Time Data are analyzed at Scale UP/Exhibit Manufacturing Scale by IN LINE/ ON LINE / AT LINE / OFF LINE analyzers & Real time data are compared with Raw scale OFF LINE / AT LINE data for Finalization of Control Strategies for Commercial Scale by:
1.In Line Analysis: Sample is not removed from process stream, can be invasive or non-invasive
2.On Line Analysis: Sample is diverted from process stream, may be returned to the process stream
3.At Line Analysis: Sample is removed , isolated from & analyzed in close proximity to the process
4.Off Line Analysis : Sample is removed , isolated from & analyzed in far apart lab afterwards
Phase 3 : Controlling Phase
According to the ranges specified in final control strategies derived through QbD,
Autonomous Controllers are utilized at Real Time Manufacturing Scale for Continuously attaining Acceptable ranges of CMAs &/or CPPs to achieve desired in-process &/or finished product CQAs
Through implementation of PAT system along with QbD; Gains in quality, safety and/or efficiency will vary depending on the process and the product, and are likely to come from:
· Reduce production cycle times by using on-, in-, and/or at-line measurements and establishing real time controls
· Facilitate Real time release (Parametric Release) ability to ensure the in-process and/or final product quality based on in-process measurements
· Increase Process Automation which can improve operator safety and reduce human errors
· Improve energy and material use and increasing capacity
· Reduce or Prevent Product rejections, scrap, and re-processing
· Facilitate continuous processing with use of dedicated series of small-scale equipment to eliminate certain scale-up issues & to improve efficiency and manage variability
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