Chemical Engineering June 2021 - 35

Act now for a competitive edge
A PAT system can already offer a
major advantage to chemical manufacturing
facilities by interfacing with
analyzers. The importance of PAT
will continue to increase as companies
need to create data-driven applications
and highly interconnected
infrastructures
to
realize
smart
Optimal
FIGURE 3. A data driven PAT framework, such as the commercial system shown here, can help manufacturers
to greatly improve flexibility, responsiveness and product quality
Moreover, cloud-computing solutions
are fully scalable, supporting
expansions and upgrades within
chemical manufacturing plants, even
for limited periods of time. This is
particularly beneficial for chemical
manufacturers during model validation,
as they can scale-up data processing
capabilities temporarily and
downsize when these activities are
not required.
Data transparency and availability
are also enhanced by the cloud, with
multi-user access and remote monitoring
supported. Also, if equipped
with
instant
reporting
capabilities,
a PAT solution that supports cloud
computing can facilitate and streamline
the creation of suitable documentation
for quality auditing or similar
purposes.
Finding the ideal PAT system
To get the most out of cloud computing
for process control and
quality assurance, companies
need to choose a PAT knowledgemanagement
platform that can effectively
pump data to the cloud.
This will either utilize either " push "
or " pull " methods for data transfer.
In the former, data are periodically
sent by each monitored system to
a central data lake located in the
cloud. Whereas in a " pull " architecture,
a central collector periodically
requests metrics from each monitored
system.
Each data-transfer method benefits
different applications and the
specific requirements of an enter34
prise.
For example, if advanced cybersecurity
is a top priority, a PAT
data pump system based on " push "
methods is likely to offer the best solution,
as it can support controlled
access. Setting up such a system
is therefore extremely important for
producers supplying highly regulated
industries, such as the pharmaceutical
sector. More precisely, a
" push " cloud-data pump prevents a
network opening to a secure goodmanufacturing
practice (GMP) area
containing the PAT's comprehensive
data. In either case, populating a
cloud-data
lake
provides companies
with the ability to expand their
data-driven science using their best,
established tools without accessing
secure systems directly.
In addition, it can prove extremely
beneficial for chemical processing
and manufacturing facilities to
adopt a PAT system that is able to
transfer and store data in the cloud
that complies with current goodmanufacturing
practices (cGMPs)
and directives for food and pharmaceutical
producers. In this case,
companies need a PAT solution with
cloud-data-pump capabilities that
can meet regulations on electronic
signatures and records (ERES),
such as the European Union's GMP
Annex 11 or the U.S. Food and
Drug Administration's (FDA) 21 CFR
part 11, or both. Examples of products
that support data " push " to the
cloud, while addressing governing
standards of the pharmaceutical industry,
are available.
manufacturing strategies. The opportunities
and innovations offered
by industry 4.0 technologies are also
able to enhance the capabilities of
PAT and increase the benefits of this
framework (Figure 3).
In particular, a PAT framework that
supports cloud computing for data
analysis, storage and reporting can
greatly
improve
flexibility,
responsiveness
and product quality while
reducing waste, costs, energy and
resource utilization. In order to fully
reap the benefits of this technology,
it is important for chemical manufacturers
to identify a solution that can
meet the needs of their enterprise
and is secure, regulatory compliant
and easy to access. By selecting the
right system, chemical manufacturers
can leverage a unique competitive
advantage while future-proofing
their operations.
n
Edited by Gerald Ondrey
References
1.
2.
Cogdill, R. P., Knight, T. P., Anderson, C. A., and Drennen, J.
K., The Financial Returns on Investments in Process Analytical
Technology and Lean Manufacturing: Benchmarks and Case
Study, J. of Pharmaceutical Innovation, 2(1-2), 38-50, 2007.
Lee, W. B., Widjaja, E., Heng, P. W. S., and Chan, L. W., DeRisking
Excipient Particle Size
Distribution Variability with
Automated Robust Mixing: Integrating Quality by Design and
Process Analytical Technology, European J. of Pharmaceutics
and Biopharmaceutics, 157, 9-24, 2020.
3.
Steinhof, O., Next Generation Manufacturing at Biogen. Presentation,
2020.
Available
at:
cast/10519/450488 (accessed: November 30, 2020).
4. Calabrese, G. S., and Pissavini, S., From Batch to Continuous Flow
Processing in Chemicals Manufacturing, AIChE Journal, 57(4),
828-834, 2011.
Author
Martin Gadsby is owner and director
of Optimal Industrial Technologies
Ltd. (5 Monarch Court,
Emersons Green, Bristol BS16
7FH,
U.K.; Phone:
+44-1454333222;
Fax: +44-1454-322240;
Email:
mgadsby@optimal-tech.
co.uk). He has over 30 years of
experience in process automation
and PAT. Before founding Optimal,
he worked as R&D European Group Leader for Kraft
Foods. Optimal Industrial Technologies is a market
leader in the field of PAT and has developed the PAT
knowledge-management system, synTQ (www.syntq.
com). Gadsby graduated in engineering with an honors
degree from the University of Bath in the 1970s.
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