Water and steam systems: water used as excipient, cleaning agent or product dilutent, and water quality selection criteria; generation, storage, and distribution systems; bio-burden control; USP PWS (purified water systems) and USP WFI (water for injection) systems; engineering considerations, including specification, design, installation, validation, operation, testing, and maintenance; common unit operations, including deionization, reverse osmosis, distillation, ultrafiltration, and ozonation systems; process considerations, including pretreatment, storage and distribution, materials of construction, microbial control pyrogen control, and system maintenance; FDA requirements; clean-in-place systems; and steam generation and distribution systems.