EU Reflection Paper on Water for Injection (WFI) by RO
In March 2008 the EMEA issued a “Reflection Paper” on WFI by RO. Exactly why the EMEA wants to stimulate this discussion at this time is unclear. There does not appear to be a ground swell of opinion among users or suppliers to lobby for a change in the regulations to allow the use of membranes to manufacture WFI water such as there was in the 1990s. Rather, with the progression to hot water sanitisable systems there is probably a trend the other way and some companies are considering using distillation to make both WFI and Purified Water, particularly where the Purified Water volume requirement is relatively low compared with the WFI usage. Putting in a new Purified Water generation and distribution system is now around the same cost as putting in a new WFI generation and distribution system, not because the product quality requirement has changed but because the expectations of inspectors and industry approaches have changed.
All aspects of quality and regulatory requirements for WFI will be discussed in detail in our training course “Sterile Products Manufacture” to be held in Manchester in September.