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Physical containment of biotechnology processes requires the following: (1) the selection of an appropriate fermenter and associated equipment, (2) suitable exhaust gas treatment, (3) consideration of the potential for overpressurization and its subsequent relief, (4) the installation of suitable inoculation and sampling systems, and (5) the collection and inactivation of condensate that may contain viable organisms. When the system is properly operated and adequately maintained, the potential for an unplanned release of viable biological agents is minimal. However, plans must be developed to deal with this eventuality to provide simultaneous employee and environmental protection. Three scenarios that must be considered are spills confined to the interior of a biological safety cabinet, unconfined spills in the open facility, and catastrophic failure of a large fermenter. Each is a unique situation that requires a specialized response by spill cleanup personnel. This paper describes an effective spill control program that is proactive and anticipatory in approach and focused primarily on prevention and secondarily on emergency response.
bioprocessing, spills, confined spills, unconfined spills, large-scale spills, physical containment, contained sampling, contained inoculation, disinfectants, exhaust gas treatment, closed system
Van Houten, J
Corporate manager, Biological Safety, Merck & Co., Inc., Rahway, NJ