Production of Water for Injection by Membrane Process

Raverase osmosis or ultrafiltration systems have generally been regarded as hard to validate about WFI production. Though the Japanese and US Pharmacopoeias have allowed distillation and RO to be applied to WFI production process, only water stills, especially multiple effects have practically been employed for parenteral water production. On the other hand, the latest analysis has shown that even distillate contains such volatile organic matters as trihalomethanes and traces of heavy metals at a little higher concentration than supposed. The JP requires TOC to be monitored in WFI process based on RO or UF systems to control the concentration below 300ppb, but very few monographs or papers have so far been published about the concentrations of organic volatile matters in distillate. (See table 1-1) Therefore, this paper proposes a new applicable WFI systems based on the result of purified water analysis with some membranes used in the process. A well combined membrane system with other units could be expected to provide less amount of impurities in membrane-treated water than in distillate.