Armed with this new remote control capability the technician was able to monitor and control the process while making adjustments to the system all by himself. With the use of
this type of technology one technician was able to do what
previously took 2 technicians communicating via radio.
How are 21 CFR Part 11 and PAT changing automation practic-
es and the types of automation solutions that end-users seek?
Ullah: Automation practices need to be flexible enough to
keep up with the regulatory requirements
for new Process Analytical Technologies
as well as 21 CFR Part 11. The best scenario would be to invest in an automation
platform that can easily and quickly be
updated through simple software updates
without having to invest in a new control
platform every time there is a change.
Butler: The use of Electronic
Signatures/Records and Process Analytical
Technology have fueled the use of manufacturing execution systems (MES) within
the automation solutions market. The MES
acts like a bridge between the shop-floor automation (PLCs), supervisory control and data acquisition (SCADA)/human machine
interface (HMI) systems) and the enterprise solutions like enterprise resource planning (ERP) systems. The need for visibility in
the pharmaceutical production process has driven many companies to look at their process control and find solutions that
connect the different automation layers.
Edwards: Overall, quality is improving, but the devil is
in the details as more data does not necessarily yield more
usable information. Everything from nuisance alarms to
interlocks that force a certain sequence of events and conditions for moving forward can have tremendously positive
impacts on improving process control, but these constraints
can also reduce efficiency. Ultimately, an appropriate balance of automated controls and experienced operation of a
system or process is the best combination. There are many
steps in a number of manufacturing processes, but especially
pharmaceutical manufacturing that can be done by “robots.”
The key is that until you can teach a robot what to do when
things don’t go as planned, the job of the skilled manufacturing engineer or technician is very secure.
Do you notice that certain pharmaceutical manufacturers
are struggling to keep up with automation trends, or do
they seem to adapt quickly overall?
Ullah: How quickly manufacturers adapt to automation
trends largely depends on the size and scope of the facility.
Automation platforms are costly to implement and validate.
Process controls for cGMP are labor intensive so changes cannot be made on the fly. Instead we see a trend toward facility
automation for new construction rather than existing facilities.
In addition, dcs systems are being scaled “down” to accommo-
As you look toward the future, how to you predict that
date for single-use process equipment, while plc systems are
being scaled “up” to harmonize all unit operations for facilities.
Edwards: In any highly regulated industry, change is al-
ways difficult. In other industries with fewer safety implica-
tions, new technology can be implemented more quickly. Ten
years ago, I would have told you that the pharmaceutical in-
dustry moves much too slowly and that they are missing too
many opportunities for improvement. Today, now that I have
a more complete and complex understanding of what is re-
quired to effectively implement change, I would say that cer-
tain companies are doing a laudable
job in deploying new technologies.
Overall, though, there is great room
for improvement. With the reduced
cost of many automated processes
and systems, many smaller and mid-
sized pharmaceutical companies and
even CMOs are beginning to take on
projects and technologies previously
reserved only for big pharma. I believe
this is a very positive trend.
Butler: Companies that embrace
technology seem to be ahead of the
curve in implementing automation technology. In general
terms companies with lower profit margins such as Generic
Drug Manufacturers are not implementing as much process
automation compared to branded manufactures.
the process control and automation landscape will change
within the pharmaceutical industry?
Butler: Looking into the future of process control and automation, the landscape will continue to change as advancements in technology introduce new products. The convergence of smart sensors, internet and cloud computing and
other new advancements will continue to bring new solutions to the pharmaceutical market. Specifically these new
advancements will enable Automation to be used as a tool
for continuous improvements for smaller companies, with
far fewer resources. They will be able to adopt lean practices and achieve significant savings in Overall Equipment
Efficiency (OEE) for legacy systems and equipment.
Ullah: The automation landscape is expected to gravitate
towards more powerful, configurable systems for controlling
processes both upstream, downstream and allowing local instruments to be added, removed or swapped out depending
on the needs of the process. We anticipate that controllers will
become more plug-and-play to address continuous processing
and integration of multiple functions (e.g., on-demand media
prep, cell culture and harvest) into a single unit operation.
Edwards: I believe that process control and automation
will continue to decrease in cost and be better implemented
throughout a wider range of processes and companies. The
emphasis on data gathering will change to more information
and knowledge management to the benefit of the manufacturers and ultimately the patient. ■
"Looking into the future
of process control and
automation, the landscape
will continue to change as
advancements in technology
introduce new products."