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.”
Posted by Dr. Tim Sandle
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