Chemical Engineering February 2022 - 12

Newsfront
PAT Framework Provides
Benefits in the CPI
Beyond product quality, process analytical technology (PAT) strategies optimize processes and
efficiency in the chemical process industries
IN BRIEF
BENEFITS OF PAT
TOOLS OF THE TRADE
DIGITALIZING PAT DATA
NEW APPLICATIONS FOR
PAT
T
he process analytical
technology
(PAT) initiative was started by the
U.S. Food and Drug Administration
(FDA) in 2003 to ensure quality of
product in the pharmaceutical industry; however,
many sectors of the chemical process
industries (CPI) had already been incorporating
similar strategies. Today's advancements
in analytical technologies and digitalization
have taken these practices further, providing
benefits in efficiency and optimization, as
well as product quality and consistency.
PAT provides an integrated framework that
enables real-time measurement of the quality
attributes of a product during the manufacturing
process. Companies can steer and
optimize these quality measurements via
multivariate control of critical process parameters.
While the framework reflects the
concept that quality cannot be tested into a
product but must be deployed throughout
the life of the product, adopters found that,
in addition to generating actionable insight
into processes to enhance product quality
and consistency, the in-depth understanding
that this framework provides can create additional
benefits.
Benefits of PAT
According to Merilee Whitney, head of the
BioContinuum platform, Millipore Sigma, the
U.S. and Canada Life Science business of
Merck KGaA (Darmstadt, Germany; www.
emdmillipore.com), employing PAT helps
processors in key aspects, including:
* Process improvement - monitoring, in
real time, process parameters and quality attributes
for greater process understanding
and optimization, control and reproducibility
during development phases
* Process automation - reducing off-line
sampling and manual feeding via an automated
nutrient control-loop strategy and decreasing
the risk of contamination and minimizing
the risk of batch failures
* Product yield and quality - understanding
real-time process knowledge through
12
Mettler Toledo
FIGURE 1. Shown here is a PAT-equipped Synthesis Workstation
for Process Development and Optimization. For accelerated
process knowledge, Easymax automated reactor is
equipped with ReactIR in situ FTIR and ParticleTrack particle
characterization PAT. Used in conjunction with Dynochem
process modeling, the technology facilitates rapid development,
optimization and scale-up of chemical reactions and
crystallization processes
PAT to help increase product yield and product
quality
Further, PAT frameworks can help lower
manufacturing and development costs and
processing times, as well as improve productivity
and efficiency, says Martin Gadsby,
CEO at Optimal Industrial Technologies (Bristol,
U.K.; www.optimal-ltd.co.uk). " These
frameworks can also enhance capability
and sustainability, facilitating the reduction
in the footprint of existing facilities. In effect,
the comprehensive overview offered by PAT
enables companies to clearly pinpoint where
and how processes can be improved from
both quality and commercial perspectives. "
PAT has been successfully applied to both
process development and manufacturing activities.
" In process development, PAT is used
for defining critical process parameters, quality
attributes and design space in which the
process operates in a manner that ensures
optimal yield, quality and safety and minimizes
byproducts that require additional workup
and waste disposal, " says Ulrich Schacht,
CHEMICAL ENGINEERING WWW.CHEMENGONLINE.COM
FEBRUARY 2022
http://www.optimal-ltd.co.uk http://www.emdmillipore.com http://WWW.CHEMENGONLINE.COM
Chemical Engineering February 2022

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