Revised water for injections guidelines offer greater choice of techniques

摘要

Distillation has long, been the method o f choice for the production of .water for injection (WFI) for the biopharmaceutical industry. Although the United States and Japanese Pharmacopoeias have allowed the use of other technologies for some years, it was not until April 2017 that their European counterpart amended its guidelines to permit the use of alternative techniques that generate water of an equivalent quality.