Requirements for ultra pure water process and water quality for pharmaceutical industry

The requirements for pure water in the pharmaceutical industry are generally divided into purified water and water for injection. Purified water requires strict water quality and water preparation process. The requirements for water for injection are more stringent, especially for endotoxin. It is required to store, produce and classify the water under a qualified endotoxin production process. The process requires the use of secondary reverse osmosis plus distillation, and the equipment must be sterilized regularly. The transportation material of the equipment is required to be sanitary grade ss316L.

 The process of pharmaceutical ultrapure water equipment generally adopts two-stage reverse osmosis. The water quality requires conductivity less than 2us/cm, TOC content less than 0.5mg/l, and bacterial content less than 100cfu/ml. The process requirements include quartz sand filtration, activated carbon filtration, softening, two-stage reverse osmosis, ultraviolet sterilization and terminal microfiltration.