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PROCESS ANALYTICAL TECHNOLOGY (PAT)
Petr Beňovský

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PROCESS ANALYTICAL TECHNOLOGY
WHAT IS PAT?
FDA’s vision:
A system for designing, analyzing, and controlling manufacturing through timely measurements
(during processing) of critical quality and performance attributes of raw, and in-process materials
and processes with the goal of ensuring final product quality for a significant number of products
on the market or in development

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PROCESS ANALYTICAL TECHNOLOGY
WHAT IS PAT?
Any in-situ measurement that participate in control or gathering data for understanding of the
process;
E.g. FTIR, Raman, ATR-UV, NIR probes, MS, HPLC, FBRM, PVM, NMR;
PAT probe can measure either chemical or physical aspects (flow, temperature, pressure, pH value);
PAT role in development is process understanding;
PAT role in manufacturing is a control strategy tool;

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PROCESS ANALYTICAL TECHNOLOGY
WHY USE PAT?
•The use of PAT can improve R&D efficiency and minimize personnel hazard;
•Speeds up processes à sampling, analyses
•Reliable, rapid analyses of a process
•Significant data for developing process chemistry inderstanding (detection of reaction
intermediates, mechanisms, relationship between process variables);
•Reduction of the number of critical parameters;
•Results in set of controls (off-line or in-line);
•Fully supported by authorities;
•More frequent data collection;
•Automated measurement;
•Real time process control;
•Eliminates difficult and hazardous sampling

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PROCESS ANALYTICAL TECHNOLOGY
WHEN TO USE PAT?
Depends on many factors throughout the product life cycle:
•
•Development
•Manufacturing (e.g. heterogeneous reaction sampling)
•Troubleshooting
•Capacity of PAT tools
•Sensitivity of a PAT tool
•
Especially useful during continuous processes

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PROCESS ANALYTICAL TECHNOLOGY
WHEN TO USE PAT?

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PROCESS ANALYTICAL TECHNOLOGY


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PROCESS ANALYTICAL TECHNOLOGY
Chanda, A. et al Org.Process Res.Dev. 19, 63 (2015)

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PROCESS ANALYTICAL TECHNOLOGY
Chanda, A. et al Org.Process Res.Dev. 19, 63 (2015)