Testing Water For Pharmaceutical Applications

By Lifecycle Biotechnologies

Water feeds nearly every stage of pharmaceutical, device, biologic, and cell- and tissue-based manufacturing, but the grade a process actually needs is rarely obvious.

Under USP <1231>, each water type is defined by the tests it must pass: TOC and conductivity at the base, then endotoxin, sterility, particulates, and others as the grade climbs. A comparison table shows which tests apply to Water for Injection, Purified Water, Pure Steam, and the sterile and bacteriostatic varieties, and a few grades carry pH, calcium, carbon dioxide, or sulfate checks of their own. Specify too low and the product is at risk; specify too high and you pay for testing you do not need.

Work through the table and the test definitions to check your own water types against them.