In its 2020 water quality guideline, the European Medecines Agency requests that if detergent is diluted for the cleaning of an equipment, the water must be of the same grade as the final rinse water.
For parenterals, it is common practice to use WFI for the final rinse. That implies that WFI should be used for the cleaning step (if we caustic a caustic solution). The impact is huge in terms of cost while providing little or no risk reduction for the patient.
Do you know of pharmaceutical companies that have implemented this requirement in their procedures ?
Regards