ISO 22519: A Flawed and Counterproductive Standard

The article “New ISO Standard Available for Water Systems,” was recently published on the PDA Letter website. In our view, this article erroneously “promotes” the ISO 22519 Purified water and water for injection pre-treatment and production systems standard released in June.
In response, our team of recognized pharmaceutical water industry leaders encourages the prompt repeal of ISO 22519 based on technical criticism. Below is an outline of our criticism with information pulled from both the ISO 22519 standard and the PDA Letter article. This article highlights several critical technical inaccuracies and biases in the standard which render it unusable and irrelevant. Only the most serious f laws in the standard are discussed, although there are numerous other points of concern.