WFI production with Reverse Osmosis based system
Of the various different qualities of water used in the pharmaceutical industry, the most critical is Water for Injection (WFI). This is the water that is used for the manufacture of parenteral solutions; products such as vaccines and intravenous drips that are injected directly into the body. The quality of WFI is prescribed in the three principal pharmacopoeias – the US, European and Japanese – and they are in broad agreement: conductivity <1µS/cm, total organic carbon (TOC) <0.5mg/l, total bacteria count <10cfu/100ml and endotoxins <0.25EU/ml. Where they have differed is in the method of production. Whilst the US and Japanese pharmacopoeias accept distillation or reverse osmosis, the European Pharmacopoeia (Ph. Eur.) has always insisted on distillation. But that is about to change.
A revision to the Ph. Eur. Monograph 169 Water for Injection allows, from April 2017, production “by distillation … or by a purification process that is equivalent to distillation. Reverse osmosis (RO), which may be single-pass or double-pass, coupled with other appropriate techniques such as electro-deionisation, ultrafiltration or nanofiltration, is suitable”. This brings Ph. Eur. in line with the US and Japanese pharmacopoeias, but what does it mean for pharmaceutical engineers?
Veolia’s Orion packaged Purified Water system has, as standard, single or twin pass RO, membrane degassing to remove dissolved carbon dioxide, volatile organics and oxygen, and final continuous electro-deionisation to achieve a conductivity of less than 1,0µS/cm at the point of use. It is fully heat sanitisable and with the addition of an optional ultrafiltration module to ensure endotoxin removal - it meets all the requirements of the new WFI Monograph.
For more information download our Concise Guide to Ph. Eur. WFI Monograph Changes http://form.jotformeu.com/70153268674359