Storage Delivery and Qualification of Pharmaceutical Waters T23 - Full Course Recording

Course Description: This training course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the Water and Steam Systems Baseline® Guide (3rd Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered. The course will include discussion of the upcoming European Pharmacopoeia regulatory change allowing alternative WFI production methods in addition to distillation. The change will align EP requirements closely with USP WFI production methods opening opportunities for membrane-based systems. The course will also include material from the new ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam and Process Gases and will review optimizing sampling plans to significantly reduce operational costs.