Overview of the Requirements on WFI in the EU, USA and Japan
Recommendation
28/29 September 2021
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Again and again, the question arises about the limits laid down in the different GMP regulations and Pharmacopoeias and what procedures are applicable to the manufacture of water for injection (WFI). The table below gives you an overview of the current requirements on the production as well as on certain testing elements. It is remarkable to notice that only EU authorities are against the inclusion of membrane procedures for the production of WFI.
|
| USP | EP | JP |
| Production of WFI | Distillation or purification process proven to be equivalent or superior to distillation | Distillation only | Distillation or RO/UF |
| Conductivity [µS/cm at 25 °C or equivalent at other temperatures] | 1.3 | 1.3 | 1.3 |
| TOC [ppb] | ≤ 500 | ≤500 | ≤ 500 |
| Endotoxin | 0.25 EU/mL | 0.25 EU/mL | 0.25 EU/mL |
| Bacteria [cfu/100 mL] | 10 | 10 | 10 |
| Nitrates [ppm] | N/A | 0.2 | N/A |
| Ammonium [mg/L] | N/A | N/A | N/A |
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