Water is an essential part of everyday life, and certain cleanrooms are no different - especially in pharmaceuticals. But water is unique apart from other products and process ingredients because ultrapure water is not subject to testing or batch-lot release before use and is drawn from on-demand systems. Additionally, results from water testing are not always available immediately because it requires time for microbiological tests to be performed.
Thus, it is critical that ultrapure water is stored and produced correctly.
The World Health Organization (WHO) felt the same way. In 2017, the WHO Expert Committee on Specifications for Pharmaceuticals Preparations (ECSPP) issued a recommendation that the WHO Secretariat gather feedback on if they should update good manufacturing practices (GMPs) on water for injections (WFI). In early 2019, the WHO Secretariat issued a draft guidance that allowed for the production of WFI by different processes than distillation.
Now, we operate under these new guidelines for ultrapure water production and storage. And if you’re using ultrapure water in your pharmaceutical cleanrooms, it is vital you understand these GMPs.