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From April 2017, the new WFI monograph on EP (European Pharmacopoeia) no. 10 entered into force from a legislative point of view. Thus, WFI is conditioned by reverse osmosis, electrodeionization and ultra filtration. This convention also allows us to offer this type of water purification.
Obtaining highly purified water by the separation membrane method, respectively RO-EDI is accepted and described in EP in the same way as the method described by USP.
It is a big step forward from the classic, energy-intensive water distillation method to RO-EDI with similar results and a visible improvement in the reduction of endotoxins in WFI.
The cold WFI method, as it is known worldwide, allows the production of water for injections at high yields, on scalable installations and, as I mentioned earlier, with much lower operating costs due to the drastic decrease in energy consumption.
Practically, almost regardless of the amount of WFI obtained, the consumption does not exceed 2 – 2.5 KW if we take into account the pretreatment section of the feed water (drinking water).
The first WFI production, storage and distribution system by the method of separation membranes was requested in 2019 by the company PLUSH Biocosmetics from Ploiești for use in recipes for organic cosmetics, without added preservatives and with a degree of absolute purity.
The plant of coldWFI production by reverse osmosis RO and EDI electrodeionization uses RO membranes and EDI cell for pharmaceutical use, GMP and FDA approved, thermally sanitizable at 800C at a capacity of 350 l / h WFI.
The results speak for themselves:
- Conductivity after RO 2 µS / cm; after EDI 0.037 µS / cm at the outlet to the WFI storage tank and maximum 0.7 µS / cm in the recirculation loop
- TOC max. 5 ppb (parts per billion) in the recirculation loop
- Non-existent microbial load
- Endotoxins non-existent