Process Analytical Technology (PAT)

Pharmeuropa Volume 30, Issue 1 (January 2018) contains a new monograph on ‘Process Analytical Technology’.

The introduction reads:

“Process analytical technology (PAT) can be defined as a system for designing, analysing and controlling manufacturing processes through timely measurements (i.e. during processing) of critical quality attributes (CQA), and critical performance characteristics of raw materials, in-process materials and processes, in order to ensure the quality of the final product. It is important to note that the term ‘analytical’ in PAT is used in a broad sense to include chemical, physical and microbiological measurements conducted in an integrated manner and combined with data analysis. The goal of PAT is control of the manufacturing process and enhanced process understanding, guided by risk management. Interfacing manufacturing processes with analytical techniques is therefore essential in PAT, as it facilitates process development in accordance with quality by design (QbD) principles, enables real-time release testing (RTRT) and supports continuous manufacturing processes.

Time delays between obtaining a sample for testing, analysis of that sample and any consequent outcomes must be taken into consideration when applying PAT. When the analytical results are used on a continuous basis to monitor and control a process, it is important to minimise such delays. This can be achieved most effectively with sensor-based continuous measurement systems directly interfacing with the process stream during a specific unit operation. The sensors continuously measure the process conditions and material characteristics within the process environment (in situ) and send the measured data (e.g. a spectrum) to an operating system where it is recorded and analysed, and where any necessary adjustments to processing conditions can be determined on a continuous basis. These in situ measurements can generate very large volumes of data representative of the process.”

For details see: Pharmeuropa

Posted by Dr. Tim Sandle