Boehringer Ingelheim Pharma GmbH & Co. KG needed to build a new multi-product biopharmaceutical plant at its site in Biberach, Germany. This new facility would be responsible for development and production of products related to diseases of the respiratory and central nervous system, and metabolic disorders. Fulfilling that charter required state-of-the-art automation technology matched with strong project execution skills, scalability, and compliance with regulations and guidelines, such as U.S. FDA 21 CFR Part 11, to meet its automation challenges and aggressive timetable.

Boehringer Ingelheim is a research-driven company dedicated to developing, manufacturing, and marketing pharmaceuticals that improve health and quality of life. With more than 37,400 employees and 143 affiliated companies spread over the globe, the company’s core businesses are human pharmaceuticals and animal health.

With a strong commitment to producing products which represent high therapeutic value for patients, physicians, and healthcare providers, the company depends on maintaining best-in-class research and development along with world-class manufacturing capabilities. As part of realizing that commitment, Boehringer Ingelheim launched the new facility on its Biberach site. The company says the operation is Europe’s largest biopharmaceutical and cell culture plant for the manufacture of proteins from mammalian cell cultures. Even with its ambitious scale, it set a new record in development and construction, and has emerged as a technology leader.

Process engineers guiding the project had to select an automation control system to monitor and manage all production processes, from fermentation via product harvesting, to protein purification, as well as all necessary utility systems. “We had to find a way to overcome a variety of automation challenges including complex batch implementation, management of movable equipment, and connection to package units, card readers, and full interoperability with a manufacturing execution system,” said Guenter Oswald, vice president of engineering and technology at the Biberach facility.

The company faced very stringent requirements and factors such as application complexity, strict regulatory requirements and an aggressive timetable to gain production capacity.

Boehringer Ingelheim selected Honeywell Process Solutions’ Experion platform for its advanced technology, robust software and monitoring, built-in redundancy, ability to integrate with manufacturing execution systems (MES), validation support, and competitive price.

“With this new biopharmaceutical plant we had very specific constraints such as the complexity of the application software, the mere size of the installation and the aggressive timetable,” Oswald adds. “Honeywell met our requirements with a superior technical solution and strong project execution, meeting our project schedule and leading us to a stable and reliable manufacturing process. Our decision was based on finding a solution that could meet specific automation requirements such as complex batch execution, high availability, data collection, and preservation that met manufacturing and regulatory requirements but at the same time let us get products out in time. We selected Honeywell because it was a better technical solution and because of its strong project execution skills.”

The new control system provides integration of field equipment and data, the distributed control system (DCS) for batch automation, and advanced process control (APC). Benefits included:

• Secure reproducibility of production and support processes by reliable process automation system;
• Fast commissioning and startup of the facility supported by enhanced diagnostic features;
• Paperless plant operation and documentation by 21 CFR Part 11 complaint data collection and storage, secure system access, and a full, real-time integration of an MES;
• System architecture scalable from small to huge manufacturing plants while maintaining high system performance;
• Easy configuration of continuous and batch control to add new products and newer technology units to the plant; and,
• Fast application development and verification supported by extended simulation features of the system.

Experion ties plant operations to business operations. To put such an enterprise-wide system in place, companies need an enterprise automation strategy—a long-term plan that blends leading-edge technologies, advanced applications and intelligently leveraged suppliers.

Oswald concludes, “We have found a long-term strategy for automation control that meets our requirements for biopharmaceutical production plants.”