PDA Letter Article

New ISO Standard Available for Water Systems

by Shlomo Sackstein, Biopuremax


7 Major Highlights from the New ISO 22519 Purified Water and Water for Injection Standard

The final water specifications for Purified Water (PW) and Water for Injection (WFI) are given in national and international standards and are well defined and well understood. On the other hand, water systems come in all shapes and sizes; some need daily maintenance and some are grossly inefficient. Some have excellent microbial standards and some require close supervision. Water systems must adapt in response to feed water quality, meet budgetary constraints and keep in accordance with both company policy and cGMP.