Preparation of water for injection by distillation
Answers
Explanation:
Water for Injection (WFI) can be produced with a number of water treatment processes to meet the United States Pharmacopeia (USP) standards. Among the water treatment processes, distillation is the only WFI method of production that is approved by the European Pharmacopeia (EP). Distillation can produce water with low microbial levels and can also remove endotoxin. A vapor compression distillation system meets all pharmacopoeial requirements and offers other advantages. However, it may produce pyrogenic product water and the product water from the still may even fail the endotoxin test. A number of other separation methods can remove endotoxin. Heat, distillation, ultrafiltration, reverse osmosis, filtration, ozone, ultraviolet light, and chemical methods can all achieve low microbial levels in the product water. Four such case studies are discussed on using membrane-based technologies to produce WFI and to illustrate the advantages of these methods.