The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance. his latest version describes new variations in the European Pharmacopoeia for the manufacture of Water for Injection by methods other than distillation. Additional changes include discussions on the global harmonization of water quality attributes, comprehensive pretreatment design, rapid microbial monitoring, ozone for ambient sanitization, and membrane technologies. This version is aligned with the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition).
The newly updated guide is the most comprehensive guide for Pharmaceutical Water and Steam systems with up-to-date international regulatory references, standards, and mandates. Hear from the guide team leads themselves as they catalogue how the new Water and Steam Baseline Guide Vol. 4 (published in October 2019) is different. The new document contains options, nuances, and design criteria for many different applications in water systems including but not limited to newer innovations, technologies, philosophies and approaches for the biopharmaceutical industry.
Come participate and discern for yourself how this comprehensive document can provide you with the professional knowledge you seek.