Biopharmaceutical company optimizes manufacturing processes with modern DCS
Gilead Sciences used a new, flexible distributed control system (DCS) for a pilot lab to support research and development (R&D), clinical trials, and meet pipeline demands.
A new distributed control system (DCS) is helping a biopharmaceutical company in a pilot laboratory application support research and development (R&D) and meet pipeline demands. A system integrator helped with design, programming, and implementation of the new process control system. Process data collection and analysis helped with proactive maintenance and regulatory requirements and an industry-specific object library saved weeks of programming time.
For 30 years, Gilead Sciences, Inc., headquartered in Foster City, Calif., has developed treatments to address significant unmet medical needs. Gilead uses pilot labs, specifically designed for the research and development (R&D) phase, to manage the various, precise manufacturing processes for all of the different drugs it creates. To meet the growing demand within the biopharmaceutical industry, Banks Integration Group was tasked to design, program, and install a process control information system within a constructed pilot lab to provide an easier way to collect data, reporting, and provide enough flexibility to grow with Gilead.
Selecting a DCS for the new pilot lab
Gilead invested in constructing a facility within their Gilead Foster City campus. This state-of-the-art facility would house an active-pharmaceutical-ingredient, small-molecule pilot lab capable of supporting all R&D and clinical phase 3 trials. The 23,914-sq-ft facility needed to house two glass-lined reactor suites and one corrosion-resistant steel reactor suite in addition to various drying equipment.
Banks Integration wanted a system that could easily integrate with the new equipment and vendor-supplied control systems in the new pilot lab. The team also wanted a system that was not too different from the system in the old pilot lab reactor suites to reduce training time for operators and process chemists who regularly worked on the equipment.
Banks Integration selected a virtualized DCS to meet project requirements and reduce server hardware. Having one common system across all of the facilities would allow Gilead the flexibility to maintain the system and make necessary changes, which has something it had struggled to do in the past with other proprietary systems. The new system would be easy for employees to use and flexible enough to meet the company’s fast-paced needs and changeovers.
"There is a mix of people who use the system from day-to-day, including operators and scientists," said Angelo Puglisi, senior automation engineer, Banks Integration. "Each group has specific requirements for the control and software systems -whether it be mixing batches in reactors or reviewing historical reports for various equipment. The system needed to be flexible enough to adapt to whatever processes and drugs they are working on at any given time."
To help speed development time, Banks Integration leveraged the DCS library of process objects for life sciences. This "out-of-the-box" library of modules included preprogrammed code, modules, and faceplates customized for life sciences applications and a full set of design and testing documentation that followed the good automated manufacturing practice (GAMP) lifecycle model. Using the process objects library allowed Banks Integration completed the programming in days compared to weeks.
The built-in displays on the system enabled Banks Integration to troubleshoot issues in the development process. The simulation mode streamlined logic testing of motors and valves in the design phase. This testing environment meant Banks Integration didn’t have to manually force feedback status inputs in the control system during sequential logic testing.
Less programming, hardware
For Gilead, a big benefit of using the library of process objects for validation testing meant they had the necessary design and test documentation, knowing that the automation vendor had tested and verified the modules. This also meant Gilead could easily verify that the pilot lab would be ANSI/ISA-88-compliant for batch control.
The virtualized platform consisted of nine virtual servers, but only required two physical host machines onsite to run the human-machine interface (HMI) and historian software. The virtualized solution helped reduce costs by minimizing the amount of hardware and power needed to run additional machines.
The information-enabled functionality of the new system included redundant historian capabilities to provide production intelligence to operators and scientists. The system collected, tracked and recorded key process data from approximately 700 historian tags to pinpoint trends, allowing for proactive maintenance activities. The system automatically collected data on temperature, flow, pressure, and more. The system pulled the data into trend reports that the scientists rely on for day-to-day decision-making instead of manually collecting the data. In addition, the new system tracked individual user actions such as logins and setpoint changes, allowing the system to meet the requirements of 21 Code of Federal Regulations (CFR) Part 11.
Banks Integration implemented five thin-client HMI stations throughout the pilot lab as part of the system. At each station, scientists can easily access historian data to view trends and pull robust reports in real-time. In the pilot lab control room, there are two physical engineering workstations where Gilead engineers can manage version control, track programmable logic controller (PLC) code changes, program backups, and schedule email reports with comparison results. The HMIs include alarm notification software. The software is integrated with the alarms and DCS’ events component and automatically send alarm email notifications to the appropriate personnel to help make more informed decisions.
"If we have a batch running in a reactor and something goes out of spec, the system will alert the alarm notification software, which sends an email to a specified group of chemists with the tag, description and additional details about what triggered the alarm," said Andy Chong, senior automation engineer, Gilead. "The chemists then have all the necessary information to identify next steps and solve the problem."
Because the DCS was built on open software and communication protocols, it could be integrated with the PLC-based original equipment manufacturer (OEM) skid equipment deployed across the pilot lab.
Improved visibility, flexibility, and scalability
It didn’t take long for Gilead to reap the benefits of their new system after the facility was completed.
"Our process chemists were very pleased with the new system’s ease of use," said Chong. "It allows for tighter control of our manufacturing process and has improved visibility at every phase."
The new system is also flexible, which allowed Gilead to adapt each manufacturing process for each different drug at the lab. The facility produces a wide range of products for research and experimentation, rather than one drug consistently. So, they created a DCS based on a reusable, maintainable library of code modules to help ensure system changeovers are streamlined. Scientists can spend more time focusing on the R&D process, rather than having to program the system software.
System scalability also means the company can expand and integrate additional systems as the future pipeline grows.
- Meet industry demand with production of new pilot lab using latest automation technology to ease reporting and enable growth.
Virtualized PlantPAx modern DCS with production intelligence
- Scalable system streamlines production and provides flexibility for future growth
- Information-enabled system improves reporting procedures through production intelligence software.
System design and delivery
- Banks Integration Group, a solution partner within the Rockwell Automation PartnerNetwork program, designed and delivered the solution.
- Robust historian and reporting capabilities help meet 21 CFR Part 11 requirements.
- Scientists are able to make system changes as needed for different production needs
- Scalable system allows for future expansions.
Stephen Rose, account manager, Rockwell Automation. Edited by Emily Guenther, associate content manager, Control Engineering, CFE Media, firstname.lastname@example.org.
KEYWORD Distributed control system (DCS)
- How a DCS can help streamline manufacturing processes
- Choosing a DCS for production improves intelligence
- How to improve the data collection and reporting process.
How can other industries optimize their manufacturing processes with more modern control systems?
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Learn more about Banks Integration Group in the Global System Integrator Database.