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OPERATIONS

Manufacturing Process Automation


Finding a Pathway Forward

by Randy Tatlock

W
hen you think of futuristic two kinds of people: manufacturing
manufacturing facilities technology innovators/implementers
and processes, robots might and users. If users are not fully
come to mind in a science involved in prioritizing their needs,
fiction setting where humans are then innovators may continue down a
absent and production lines are path of developing and implementing
directed by computerized drones that technology that users do not
perform tasks we can’t even imagine necessarily want or have the time to
today. As the pace of technology understand and operationalize. Here
shuttles us swiftly into the real future, are two components at work: need
however, life-science manufacturers and understanding. Programmers
need to pause to examine the purpose should develop innovations that meet
of automation and how we can best actual needs — rather than simply,
steer its course. “cool tech” looking for a problem to
In bioprocess manufacturing and solve.
other industries, technology is As Figure 1 shows, the gap widens
growing more powerful and between the rapid pace of technology
sophisticated for solving problems. and users’ ability to learn new
General users and implementers of applications in ways that make that
www.photos.com
new technologies, however, don’t fully technology useful. That gap can
tap into available technology shrink when IT professionals and
smart-phone applications and consumer-
capabilities that exist. Sometimes the users collaborate to ensure that
based technologies. Ten years ago,
complexity overwhelms technology solutions address real-
people couldn’t imagine the plethora of
manufacturing teams and (because of world manufacturing problems — and
programs and services such as Yelp,
layoffs and consolidation) information that adequate training is offered.
Skype, or the innumerable “apps” for
technology (IT) departments’ Regulation: Second, life-science
the Apple iPhone. Imagination is the
available time. So the options are manufacturers operate under many
only true limit of future technology
outpacing the industry’s ability to regulatory requirements that
evolution, so it is presumptuous to
understand and correctly apply ultimately drive the agenda for
predict what will exist in another 10
technological solutions to its technology development. Over the
years — much less how we will keep
manufacturing challenges. past decade, quality by design (QbD)
pace with future inventions.
Despite advancing technology, the has been touted as a means to reach
same manufacturing quality problems biomanufacturing’s “desired state” of
Steer the Course of Invention
persist and are being carried into the predictability and control. The FDA’s
Technology for process manufacturing
future while untapped information Janet Woodcock has described this
grows exponentially. What prevents
capabilities may sit idle on your server. desired state: “Manufacturers have
manufacturers from leveraging
To escape this fate, manufacturers extensive knowledge about critical
available technology for the right
need to ensure that future product and process parameters and
problems is threefold and boils down
developments are implemented to solve quality attributes. . . . Manufacturers
to communication, regulation, and
the most critical problems rather than strive for continuous improvement”
education.
pursued simply for innovation’s sake. (1). Some companies have put process
Communication: First,
Both types of development are analytical technology (PAT) solutions
manufacturing industries are home to
exemplified in everyday life by new into place, but they may not fully
12 BioProcess International 10(1) January 2012
understand them or use them to their resources, and controlling costs to every action. With improved process
full potential. match benefits. understanding, teams can end up
Education: Finally, the United Cultural Change: Improved training moving toward the ideal QbD
States is struggling with an education and communication can help environment. Such process
system that may not be adequately technologists and users speak the same understanding requires collaboration
preparing the next generation of language. IT needs to do a better job across geographical and functional
scientists and manufacturing operators of training users on what technology boundaries. When appropriately
to understand and solve problems with is available and how it can be applied applied, enabling technologies can
advancing technology. Specialized to facilitate process improvements. assist with such work and in the
training is required, as well as a shift Conversely, users need to tell IT what future could lessen the effects of
to a problem-solving and collaborative will be useful and applicable and what specific manufacturing geographic
type of organization. is needed to improve their job and locations around the world.
In a 2010 article, Nyenrode business performance. Instead of Reallocate Human Resources: If
Business University professor John operating cut off from one another in manufacturers understand their
Psarouthakis shared his perspective on processes well enough and have IT
how and why the United States has Figure 1:  The IT learning curve goes up tools in place to facilitate quick
lost its manufacturing base to foreign quickly, but user knowledge doesn’t rise as reactions to problems, then some of
nations. One thought-provoking point quickly, so the gap gets bigger over time (not those processes can be automated to
really taking advantage of technology).
he made is that today’s first-graders run with fewer people.
will be entering the workforce in 2020 IT Innovation
Biomanufacturing supply chains will
underprepared as a generation, “which be more predictable, with reduced
Technology

is now struggling with the basic skills mistakes, and human resources can
of early grammar school” (2). The Potentially thus be freed up for other tasks.
Useful
article focuses on competitive threats Daniel Pink’s bestselling book A
to discreet manufacturing industries, Whole New Mind: Why Right-Brainers
but Psarouthakis wisely proposes, Will Rule the Future discusses
“Very simply, we need to solve three User Capability to Apply computer automation trends that will
dilemmas: how to develop and deploy Time replace human jobs with robots and
new technologies, how to more technology. Pink proposes that
effectively manage our manufacturing although computers can replace (and
organizations, and how to develop “silos,” technologists and business outperform) humans in many tasks,
human resources for the future.” users can instead work toward their missing element of empathy can
Those potential roadblocks to progress common goals on a common platform be delivered by humans alone. The
intersect for most biomanufacturing that involves collectively mapping out empathetic element is what enables
organizations and thus need to be “where do we go from here?” to help humans to retain their roles when
considered by companies hoping to close the gap between them. creative solutions are required (3).
move rapidly toward the desired state Organizations can look for learning In process manufacturing, there
of QbD and take full advantage of opportunities and ways to integrate will always be a role for the
IT’s potential. those into curriculums or enlist “empathetic” human. With more
distance-learning tools that can automation, companies can refocus
Freeing Humans rapidly reach far-flung users. people on tasks that are more
for Critical Tasks Better Process Understanding: important and productive. But the
Future manufacturing processes are Manufacturing problems primarily potential speed of future automation
likely to include increasing levels of stem from two sources: making depends on the complexity of what
automation. If designed appropriately mistakes due to “the human element” you are trying to automate. The
through collaboration, process and unexpected outcomes due to a automotive industry has done it well.
manufacturing technologies will lack of process understanding. When Robots do much of what people used
enable greater process understanding the goal of process automation is to to do in vehicle assembly, freeing up
that leads to QbD and automated reduce the risk of human error, employees for more value-added,
continuous quality verification bioprocesses need to be so predictable intellectually stimulating, and
(CQV). If employees are freed from that they can be automated to work revenue-generating work. Similar
repetitive manual tasks, they can the same way every time. results can be obtained in more
focus more on problem solving. The Manufacturing teams can then complex biomanufacturing, for which
following elements are required to understand what might happen and automating mundane processes could
keep pace with technology and how to react to problems as they arise. allow for more focus on drug and
leverage it as an agent for progress: That relates to QbD’s goal of process development, for example, in
cultural change, better process understanding the boundaries of a which decisions must be made
understanding, reallocating human process and potential reactions for creatively — by “empathetic” humans.
14 BioProcess International 10(1) January 2012
Controlling Costs to Match Benefits: users, technology can fall more in line advantage of technologies in place.
Return on investment will always be a with QbD goals of future process Ultimately, these combined efforts will
major consideration in life-science manufacturing facilities. free valuable human resources to work
manufacturing. Benefits of automation Manufacturing processes must be diligently on the next phase of life-
have to justify associated costs. For understood and technologies science innovation.
technology investments to make smart implemented according to such
business sense, a company needs understanding so that solutions are References
adequate resources and a well thought- developed for productive reasons. 1 Woodcock J. Pharmaceutical Quality in
the 21st Century: An Integrated Systems Approach.
out plan for retooling its organization. Only then can organizations truly
AAPS Workshop: October 2005.
Implemented technology cannot be reduce costs and save time. Cultural
2 Psarouthakis J. The Future of American
overburdensome to its users. shifts are required to keep pace with Manufacturing. The Business Thinker
Implementation teams need to access technology development as companies 2 December 2010.
the retraining needed to effectively use focus on reallocating human resources 3 Pink DH. A Whole New Mind: Why
new technology and determine to keep their processes on a path of
Group: New York, NY, 7 March 2006. •
Right-Brainers Will Rule the Future. Penguin
whether that will lead to a more continuous improvement.
cumbersome workflow rather than an Change will enable organizations to
improved situation. Such teams should correctly apply technological solutions Randy Tatlock is manager of customer
understand the total cost of ownership to solve the most important process development at Aegis Analytical Corp., 1380
for technology and automation. The manufacturing challenges. Supporting Forest Park Circle, Suite 200, Lafayette, CO
costs of retooling organizations and a productive QbD culture requires 80026; 1-303-625-2100, fax 1-303-926-1161;
redeploying staff members should not implementing available technology to rtatlock@aegiscorp.com.
consume all resources freed up by the gain access to data and provide efficient
new system. analysis capabilities to allow better
When cost–benefit analysis points process understanding; using increased To order reprints of this article, contact
Rhonda Brown (rhondab@fosterprinting.com)
to automation technologies that are process understanding to apply the
1-800-382-0808. Download a low-resolution
developed and implemented with right technologies for monitoring and PDF online at www.bioprocessintl.com.
collaboration among IT teams and control; and training people to take full