Risk Assessment—Management of Plant Utilities during COVID-19 Pandemic

Materials— Plant UtilitiesRisk IdentificationRisk RatingRisk Mitigation/Critical Process Controls
Pharmaceutical-grade waterIncoming potable waterLowMaintain existing microbial monitoring program
Pharmaceutical-grade plant airDistribution lines and delivery nozzlesLowAssure sanitary design
Compressed gasesNoneLowMaintain existing microbial monitoring program
HVAC systemPoor temperature, humidity, and air exchange; Recirculation and lack of segregationLow to ModerateReduced recirculation in more critical areas; Higher air change rates; High room ultraviolet germicidal irradiation
Domestic and clean steamNoneLowNone
VacuumDischargeLowReview vacuum discharge
Washing facilitiesPoor design and opportunities for cross-contaminationLow to ModerateAccess to detergents, hot water, and hand sanitizing agents;Segregation of clean and dirty materials
Waste and sewage disposalPoor separationModerateBackflow elimination;Segregation of clean and dirty materials