Risk Assessment—Management of Plant Utilities during COVID-19 Pandemic
| Materials— Plant Utilities | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Pharmaceutical-grade water | Incoming potable water | Low | Maintain existing microbial monitoring program |
| Pharmaceutical-grade plant air | Distribution lines and delivery nozzles | Low | Assure sanitary design |
| Compressed gases | None | Low | Maintain existing microbial monitoring program |
| HVAC system | Poor temperature, humidity, and air exchange; Recirculation and lack of segregation | Low to Moderate | Reduced recirculation in more critical areas; Higher air change rates; High room ultraviolet germicidal irradiation |
| Domestic and clean steam | None | Low | None |
| Vacuum | Discharge | Low | Review vacuum discharge |
| Washing facilities | Poor design and opportunities for cross-contamination | Low to Moderate | Access to detergents, hot water, and hand sanitizing agents;Segregation of clean and dirty materials |
| Waste and sewage disposal | Poor separation | Moderate | Backflow elimination;Segregation of clean and dirty materials |