ISPE Baseline Guide Volume 4: Water and Steam Systems soon will be released by Tampa-based International Society for Pharmaceutical Engineering.

The second edition was revised to address changes in industry practices and global regulations over the past decade. It includes tools to help pharmaceutical manufacturers meet safety requirements while avoiding unnecessary cost. It can be pre-ordered now and will be ready to ship by mid-December.

“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. We’re glad to say that it is complete, the FDA has reviewed it, and the guide is headed to the printer,” says Cameron Sipe, leader of the team responsible for revising the guide. “Water is involved in the manufacture of every pharmaceutical product in every facility around the world, so the updates in this guide are important to the manufacture of safe, pure medicines for patients all over the globe.”

New chapters address laboratory water systems and the rouge phenomenon in high purity water and pure steam systems; microbiological considerations such as biofilm formation, use of sanitizers, sampling, testing and control levels; and the overall impact of microbial considerations on unit operations and finished water.