Risk Management and Safety Engineering in Large‐Scale Biomanufacturing

Large-scale biomanufacturing involves complex processes involving life forms, hazardous chemicals, high-pressure equipment, and sterile plants which present significant risks to people/items and the environment. Throughout this chapter, the safety engineering and risk management frameworks along with the impending risk management processes dependent on the level of the large-scale biologics manufacturer will be thoroughly analyzed. It discusses common working hazards; environmental safety concerns and some engineering control measures put in place to mitigate them. The combination of process safety, levels of biosafety, engineering controls, and digital technologies of risk prediction used in the chapter are focused on the ability to meet the international regulation standards (e.g., OSHA, GMP, ISO, WHO). Pragmatic applications are implemented using the case studies of prior incidents and their mitigations. The chapter concludes by looking at the future of introducing smarter safety systems, enhanced surveillance with the help of AI and implementing strong biomanufacturing processes in relation to the sustainability of production and pandemic preparedness.