ABB Hungary Kft. has won the first CEE Pharmaceutical Excellence Award for solution providers. ABB Hungary Kft has been honoured with the Award for the automation and BMS solutions it delivered to Gedeon Richter Plc’s biotechnological facility.

The first CEE Pharmaceutical Manufacturing Excellence Award, sponsored by the Hungarian Pharmaceutical Manufacturers Association and applied for in two categories, was bestowed at the highly acclaimed PHARM Connect Congress, the most important pharmaceutical and biotechnology business summit in the Central Eastern European and the CIS region. PHARM Connect Congress took place in February 2015 and is the most important pharmaceutical and biotechnology event in the Central Eastern European and the CIS region, which was attended by about 600 decision-makers of the largest pharmaceutical and biotechnological companies operating in the region.

Industry	Pharmaceutical and life sciences
Customer	Gedeon Richter
Country	Hungary
Solutions	Complete process control system 800xA Facility automation (boilers/ cooling equipment, air-baffle units) Building Management System (BMS) Integrated Environment Monitoring System (EMS)

ABB’s award-winning project is based on an order placed by Gedeon Richter Plc, the well-known pharmaceutical company. According to the project scope, ABB supplies automation and management systems to Richter’s biotechnology facility in Debrecen.

The project represents a most important investment of Richter and is regarded as a real breakthrough in health care and unique in the pharmaceutical industry of the region. The biotechnological facility in Debrecen commissioned in 2013 uses mammalian cell fermentation to manufacture products with exceptionally high intellectual and technological added value to treat immunological and oncological diseases.

Richter has installed a fully automated, integrated and validated production, building management and environmental monitoring system in its new facility. To ensure successful project execution, Richter selected ABB 800xA technology and ABB’s engineering team, supported by international expertise and experience. 

“ABB has global and local experience as well as reliable technology and well-proven engineering background both in pharmaceutical and petrochemical industries. These values have played a key role in the successful cooperation between Gedeon Richter Plc. and ABB over the last 16 year” – said Lajos Kovács, Technical Director of Gedeon Richter Plc.“

"System 800xA provides Richter with a comprehensive automation solution, which includes the complete supervision of the buildings and utilities, in addition to that of the production units. Our experience gained in the biotechnology and ABB’s pharmaceutical solutions advocate the further developments in Batch Management, Building and Facility Automation and enable us to give state-of the-art and flexible responses to the challenges met with in this new industry”- said Bence Tóth, the ABB manager responsible for the project.

ABB has delivered the following solutions to the facility: complete process control system, facility automation (boilers/ cooling equipment, air-baffle units) as well as integrated Environment Monitoring System, all in compliance with the Good Manufacturing Practices (GMP).

The Process Automation System (PAS) has to comply with biotechnology requirements, like the requirements set forth in the Recipe-based Production Management (S88), FDA 21 CFR Part 11, and those of GAMP 5 Guidance specifying the best practices in the life-science industries

In addition to the upstream processes (including media preparation, bioreactor control, integration of centrifuges) and downstream processes (including virus activation, separation/purification and ultrafiltration), PAS controls the monitoring systems of clean-rooms, PW & WFI distribution system as well as equipment cleaning and equipment sterilization

Building Management System (BMS) is responsible for supervising the air-handling units in the production building and injection plant, ensures the integration of the utilities, manages the Environment Monitoring System (EMS) and supervises the machines.

Process Automation is an essential requirement for a modern biotech manufacturing facility. Microbiological & environmental safety is paramount and hence an effective EMS system is a key enabler. Certain elements of the technology can only be enabled by an appropriate and overarching PAS system, like the one ABB has delivered. PAS system, which drives effectiveness and efficiency, allows for the necessary integration of technology steps and the remote control of the process technology. PAS is a key element that makes Richter’s Debrecen biotechnology plant a ‘world class’ facility