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ISPE

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ISPE Releases Updated Water and Steam Systems Baseline Guide

Guide has been FDA-reviewed and addresses 10 years of changes in regulations and industry practices

Published: Thursday, November 3, 2011 - 12:13

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 22,000 pharmaceutical science and manufacturing professionals who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions, will soon release the long-awaited ISPE Baseline Guide Volume 4: Water and Steam Systems (Second Edition).

The revised and expanded second edition builds on the groundbreaking Water and Steam Systems Baseline Guide first published 10 years ago. The second edition has been completely revised to address changes in industry practices and global regulations throughout the past decade. Additionally, this comprehensive, industry-driven document will 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 second edition can be pre-ordered now and will be ready to ship by Dec. 15, 2011.

The guide, which is the only comprehensive resource of its kind, 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. The guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to contribute to the revised guide, providing continuity and longevity of vision to the guide’s contents. The guide also has been reviewed by the U.S. Food and Drug Administration (FDA), and its comments have been taken into consideration in the final version of the guide.

“In light of the fact that ISPE has literally ‘written the book’ on water and steam systems, we know the industry is highly interested in this revision,” says Cameron Sipe, leader of the task team responsible for authoring the guide. “We’re glad to say that it is complete, the FDA has reviewed it, and the guide is headed to the printer. Water is involved in the manufacture of every pharmaceutical product in every facility around the world, so the updates in this guide are incredibly important to the manufacture of safe, pure medicines for patients all over the globe.”

The ISPE Baseline Guide: Water and Steam Systems (Second Edition) has been expanded to include 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 sanitizers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water.

The ISPE Baseline Guide: Water and Steam Systems (Second Edition) will be available for pre-order at the 2011 ISPE Annual Meeting, taking place Nov. 6–9, 2011, in Grapevine, Texas, and will be available for purchase on the ISPE website by Dec. 15, 2011.

For more information on ISPE guidance documents, including the FDA-reviewed Baseline Guides series, or to order copies in either bound or electronic form, visit the ISPE website.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.