Reverse osmosis for Water for Injection

This website has previously reported on forthcoming change to the European Pharmacopeia on the use of reverse osmosis, in addition to distillation, for producing WFI-bulk (Water for Injection).

This is now spelt out in the applicable monograph “Water for injections (0169)”. The proposed text reads:

“Water for injections in bulk is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority or from purified water.

It is produced either:

– by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz or a suitable metal and which is fitted with an effective device to prevent the entrainment of droplets; The correct maintenance of the apparatus is essential. the first portion of the distillate obtained when the apparatus begins to function is discarded and the distillate is collected; or

– by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable

techniques such as deionisation and/or ultrafiltration.”

Posted by Tim Sandle