Addresses changes to industrial practices and global regulations
The US International Society for Pharmaceutical Engineers (ISPE) is to publish the ISPE Baseline Guide Volume 4: Water and Steam Systems (Second Edition) next month.
The revised and expanded second edition builds on the Water and Steam Systems Guide first published 10 years ago. It has been updated to address changes in industry practices and global regulations, which have occurred over the past decade. It aims to promote consistent and practical interpretation of regulatory requirements for water and steam systems worldwide. It includes tools to help pharmaceutical manufacturers meet safety requirements while avoiding unnecessary cost.
The new guide aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing regulations and related guidance.
Many of the team responsible for the original guide have returned to contribute to the revised edition, providing continuity and longevity of vision to the contents.
The US FDA has also reviewed the guide, and its comments have been taken into consideration in the final version.
The ISPE Baseline Guide: Water and Steam Systems (Second Edition) includes new chapters on laboratory water systems and the latest theories and industry practices addressing the rouge phenomenon in high purity water and pure steam systems.
New chapters also cover microbiological considerations, such as biofilm formation, use of sanitisers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water.