EMA paper on production of water for injections (WFI) by non-distillation methods

The European Medicines Agency has published a question and answer paper on the production of water for injections (WFI) by non-distillation methods.

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; or

·         By a purification process that is equivalent to distillation. Reverse osmosis, which may be single-pass or double-pass, coupled with other appropriate techniques such as electro-deionisation, ultrafiltration or nanofiltration, is suitable. Notice is given to the supervisory authority of the manufacturer before implementation.

The reference is:

EMA/INS/GMP/489331/2016: Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies

Posted by Dr. Tim Sandle