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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