By implementing a PlantWeb™ field-based architecture based
on a DeltaV™ digital automation system and smart field devices
from Emerson Process Management, Grafton, Wisconsin's Cedarburg Labs
is cost-effectively filling a unique niche as a contract producer
of active pharmaceutical ingredients and intermediates.
Cedarburg Labs is a startup plant. As a contract manufacturer,
it's customers include some of the world's largest pharmaceutical
companies. The facility is designed to accommodate several
customers simultaneously in four "suites" containing
glass-lined reactors varying in size from 50 to 500 gallons.
So the control equipment has to handle multi-product situations,
accommodating frequent product and process changes.
The control requirements include simple to complex control
strategies, with production processes always rigorously documented
-- all batches must adhere to current good manufacturing practices
(cGMP). Further, for scheduling purposes, and to maintain
customer credibility and repeat business, the facility must
ensure that every customer's batch is executed correctly the
first time -- on time. Process repeatability and reliability
is crucial.
Configurations often must maintain customer confidentiality
among the suites. If different customers each use a different
suite, no part of a given suite's hardware or software can
be accessible to other suites. But a single customer's product
might occupy the entire facility, so Cedarburg must also be
able to create a single plant environment, with process control
and data seamlessly integrated among all the suites.
Cedarburg Labs selected Emerson's DeltaV
automation system and various Emerson smart field
devices to automate the processes in its suites. The DeltaV
system's flexibility, combined with the integration of field
devices allowed easy configuration on-the-fly for one-of-a-kind
products.
Because each suite has its own DeltaV workstation, the equipment
in that suite can be operated and monitored independent of
other suites. Yet all workstations are networked, so the entire
facility can be operated as a unified plant from a single
workstation if needed.
"We're impressed with the flexibility and ease of use
of Emerson's DeltaV and PlantWeb architecture solution,"
said Cedarburg Labs president, Dr. James Yarger, "We
chose it as the best answer to meet our complex production
needs within our multiple use manufacturing suites."
He added, "The system will provide us
with invaluable information for use in process development,
will provide us with supporting documentation for our full
cGMP facility, and will allow us to provide our customers
with highly reproducible manufacturing processes."
Reduced installation/startup cost
Working with a single supplier for the control system and
many of the field devices simplified set-up and ensured that
all the components of the whole process control solution worked
together harmoniously.
Lower engineering cost
The DeltaV system's ease of use allowed adjustment and reconfiguration
without an in-house process control staff. Once parameters
were set in the field devices, they could all be loaded into
the controller for implementation. Any modifications could
be made from the operator interface. The configuration could
be stored for use on subsequent or scale-up projects. The
DeltaV's graphical interface and batch recording allowed operators
to quickly view documentation and determine if the process
was executed as required.
Flexibility
The DeltaV system's Windows NT workstation makes changing from one customer
batch configuration to the next easy. The process operator
simply copies existing batch modules into the new configuration
file and modifies the parameters using the DeltaV graphical
user interface.
Reduced Error
The DeltaV system allowed Cedarburg operators to model new processes.
This helped anticipate process problems and ensured correct
process execution from the first run. Not only can customers
be assured all batches will be executed properly, they can
also get accurate information to perform the continued scale-up.
Real-Time Historian
Cedarburg Labs customers need full process documentation
of their product runs. The DeltaV system provides a continuous,
real-time plant historian and batch historian, along with
event data, and batch production data to keep the operation
100% cGMP. And all this information can be interlinked to
provide meaningful data to customers for analysis.
Expandability
The DeltaV scalable system can grow as Cedarburg adds suites
and reactors into a new building. In the same way, DeltaV
can accommodate additional control devices in the existing
suites, as well as adding on new automation systems for future
sites. When expansion becomes necessary, adding new reactors
to the process control system will be as simple as copying
existing reactor configurations and modifying them, using
the DeltaV system's graphical interface.
Smaller footprint
Because each manufacturing suite is small and requires its
own process automation system, the system must be economical
and scaled for available floor space. Placing DeltaV rail-mounted
controllers and I/O modules in wall-mounted cabinets next
to the system's windows NT workstations saved valuable control
room space. Additional controllers or modules can easily be
hung on the rail and plugged into the system wiring.
More on the Cedarburg story in a Pharmaceutical Technology
Supplement: Reflections on Becoming a Successful Pilot-Scale
Manufacturer in the Changing Pharmaceutical Industry.
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