“With this new biopharmaceutical plant we were faced with various automation challenges. In addition, we had very specific constraints such as the complexity of the application software, the mere size of the installation and the aggressive timetable. 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.”

Guenter Oswald, Vice President Engineering and Technology, Boehringer Ingelheim

Boehringer Ingelheim Pharma GmbH & Co. KG needed to build a new multi-product biopharmaceutical plant at its site in Biberach, Germany. Responsible for the production of several products, this biopharmaceutical plant required state-of-the-art automation technology matched with strong project execution skills, scalability and compliance with regulations and guidelines, such as FDA 21 CFR Part 11, to meet its automation challenges and aggressive timetable. All of those factors were met with the installation of Honeywell’s Experion^® Process Knowledge System (PKS). 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
• Support paperless plant operation and documentation by 21 CFR 11 complaint data collection and storage, secure system access and a full, real-time integration of a Manufacturing Execution System (MES)
• System architecture scalable from small applications 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
• Fast application development and verification supported by extended simulation features of the system

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

Boehringer Ingelheim is committed to the goals of discovering, developing and producing products which represent high therapeutic value for patients, physicians and healthcare providers. This is achieved by best-in-class research and development and world-class manufacturing capabilities. Boehringer Ingelheim built a new biopharmaceutical facility on its site in Biberach, Germany. The plant is Europe’s largest biopharmaceutical plant for the manufacture of proteins from mammalian cell cultures. As the largest cell culture plant in Europe, it set a new record in development and construction, and currently surpasses all others in terms of technology.

Boehringer Ingelheim 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 Engineering and Technology at Boehringer Ingelheim, Biberach.

The company was faced with very stringent requirements and factors such as application complexity, strict regulatory requirements and an aggressive timetable to gain production capacity. In order to meet these challenges, Boehringer Ingelheim turned to Honeywell’s proven Experion system.

Boehringer Ingelheim selected Experion for its advanced technology, robust software packages and monitoring, built-in redundancy, ability to integrate with MES systems, full validation support, competitive price and Honeywell’s strong project execution skills. Another key criterion was the commitment of Honeywell’s management to the life sciences industries.

“Our decision to go with Experion 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,” said Oswald. “We selected Honeywell because it was a better technical solution and because of its strong project execution skills.”

Experion provided integration of field equipment and data, the distributed control system (DCS) for batch automation and advanced process control (APC). 

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