Uniform interfaces unify biotech operations

Aug. 15, 2017
While working to consolidate and automate its manufacturing processes for raw-material antigens, Grifols Diagnostic Solutions in Emeryville, Calif., recently implemented a process that allowed staff to view data from process operations side-by-side.

While working to consolidate and automate its manufacturing processes for raw-material antigens, Grifols Diagnostic Solutions in Emeryville, Calif., recently implemented a process that allowed staff to view data from process operations side-by-side with information from plant utilities and building systems, compare their performance more quickly, and achieve efficiency levels and optimization that would've been a challenge with disparate data and controls.

Grifols' antigens are used by suppliers like Abbott and Siemens to manufacture diagnostic kits, which are used to check patients for blood ailments like hepatitis-C and others. Its Emeryville plant is a full-suite biotech facility with upstream yeast and e. coli, including fermentation processes, clean-in-place (CIP) and support equipment, and downstream purification processes, centrifugation, chromatography, filling and packaging applications, all controlled by PLCs and a variety of pressure, temperature, flow, dissolved oxygen (DO) and pH instrumentation.

The plant's challenge in past years was consolidating from multiple buildings into one, and migrating its mostly manual and separated applications into an integrated whole. It also added new tanks, pipes, utilities and skids for water purification and cell inactivation, and implemented a PlantPAx distributed control system from Rockwell Automation (www.rockwellautomation.com) for the fermentation, CIP, building automation and other units, such as portable tanks for preparing growth media.

"The available existing infrastructure created challenges to acquire data from our current facilities that are spaced in separate manufacturing islands," says Zubin Najmi, principal engineer at Grifols. "We also hadn't implemented a common historian, plus we didn't have adequate automation to get data to it, even if we did have an historian. We got the new building, so we could put in the necessary infrastructure to optimize our process with better efficiencies and yields based on data, and establish a common platform for our utilities, upstream and downstream process trains to assist our operators, maintenance people and managers."

Najmi reports that Grifols has already completed a handful of two-week production runs in its new one-building application, which includes a week in fermentation and transitions from 10-liter to 250-liter vessels. So far, he adds, the process controls are performing well. Formerly manual CIP processes, as well as mixing and transfer procedures are automated with recipes and Rockwell Automation FactoryTalk Batch and Sequence Manager software, which saves a lot of time for operators. 

Najmi explains, the Grifols plant's process and building controls begin to converge around its air handling units and HVAC systems, which are also run by the PlantPAx DCS, though their actual controls don't interact. "Our process, utilities and building controls run separately, but they're displayed on the same operator interface, and have the same look and feel," he says. "This makes it easier to troubleshoot and to correlate and optimize them in relation to each other, and that's what today's big data and easy access to information are all about."

The new process plant and its air handlers also use Rockwell Automation Allen-Bradley PowerFlex drives with EtherNet/IP networking, which generate valuable data about frequency, power and health information, which is also displayed by the PlantPAx system.

"We're also using Rockwell Automation FactoryTalk Alarms and Events software, which benefits from having a common alarm platform," adds Najmi. "We can view all of the facilities alarms in one place, historize them, and pull them up as needed. The U.S. Food and Drug Administration (FDA) and ISA 18.2 alarm standard stress having an alarm philosophy, and these tools make it a lot easier."

Najmi concludes, the first phase of Grifols' consolidation project was getting the new building and processes qualified, which is mostly complete. Additional phases are planned, including an expansion on the new building's second floor, which will house other new production processes.

"The environmental conditions are just as important as the process data to users in the life sciences, food and beverage, health and beauty, and other industries, and recording their process now includes collecting process control and environmental data, too," says Chris Steffas, application center manager for the global solutions delivery team at Rockwell Automation. "This is where the value of a common architecture is demonstrated. For instance, a common control platform makes it easier to show compliance with regulatory and quality requirements because users can present their process and environmental data together."

Steffas adds, the value of the PlantPAx DCS can be leveraged equally well by operations, engineering, quality/validation staff and managers, even though they have different skills and objectives. "Operations and facilities have different requirements, but each can use the common platform of the PlantPAx system," he explains. "For example, if a user knows how to add a valve or a temperature transmitter in one area, then a common platform means they can do it across all areas in their facility, and it will report back in the same way from all of them. Previously, users had to employ signal splitters to send data to different supervisory systems, but now they can add a device or alarm once, its data is shared with both systems, and anyone has access to the information."

For the full story, read "Process, power and plant controls join forces to achieve performance."

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