ISPE Releases ISPE Baseline® Guide: Water and Steam Systems (Third Edition)
23 October, 2019
ISPE announced the release of its latest guide, ISPE Baseline® Guide: Water and Steam Systems (Third Edition). This guide provides in-depth guidance for the design, construction, operation, and lifecycle management of water and steam systems. Industry professionals can better understand Good Manufacturing Practices (GMPs), to comply with established regulations and new expectations.
This guidance document explains recent changes in compendial documents for water for injection production methods in addition to traditional distillation processes with newer interpretations, technology, and definitions.
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.
The pharmaceutical industry can apply these guidelines to their facility operations to enhance systems knowledge and ensure water critical quality attributes in new and existing water systems.
Key topics discussed in this guide:
- Changes in traditional distillation methods
- Advancements in WFI procedures
- Global harmonization of water quality attributes
- Comprehensive pretreatment design
- Ozone for ambient sanitization
- Membrane technologies
ISPE and leading pharmaceutical water SMEs have contributed their combined experience and water knowledge of more than 500 years to produce a highly valuable resource document adhering to regulatory expectations in today’s industry.