Sterile Water Manufacturing And QC Testing

Pharmaceutical water is not a single category, and treating it as one is a common source of compliance risk. Sterile waters intended for injection, inhalation, or irrigation require both sterility testing under USP <71> and bacterial endotoxin testing under USP <85>, while other water types, including water for hemodialysis and pure steam, require only endotoxin testing. Getting this distinction wrong can mean either over-testing or, more critically, under-testing products that contact the bloodstream. For endotoxin testing specifically, both traditional LAL methods and recombinant alternatives such as rCR under USP <86> are acceptable, giving laboratories flexibility without sacrificing regulatory standing. A clear map of which monograph applies to which water type is the foundation of a defensible quality program.

Review the full testing requirements for each USP water category to confirm your current approach holds up under scrutiny.