Water for Injection (WFI)

Today’s industrial water treatment systems, usually meet the WFI chemical standards but not the bacterial standards as a regular pretreatment based on softeners and active carbon will actively generate bacterial growth.
In Water for Injection systems the pretreatment systems need to combine low life-cycle costs with high reliability.

Biopuremax, a system with no chemicals and no organic media, is perfect as a WFI water pretreatment system. As the system is guaranteed to have zero total count per ml, the Biopuremax pretreatment, in conjunction with RO and CEDI, is superior to all other membrane and distillation based Water for Injection systems.

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Standards and Regulation
Biopuremax technology is recognized by the ISPE Baseline GPG, by the European Pharmacopeia (EP) and ISO Organization:

  • Maintenance

    In contrast to other membrane based PW/WFI treatment systems, the only maintenance needed on the Biopuremax is replacement of the UV lamps twice a year. The scale precipitated in the ESR™ is automatically removed by a cleaning cycle.

  • Sanitization

    When the system is first started up it undergoes a heat sanitization cycle at 85°C (185°F). As heat sanitization is a pharmaceutical “golden standard” for Water for Injection, there is no other more suitable membrane system for WFI water production. The sanitization starts at the very beginning of the PW/WFI systems, at the city water tank, and includes all the equipment and piping in the system up to the feed to the product storage tank.

    Sanitization should be performed after a long shut down but can be performed daily.

  • Bacterial Reduction

    The Biopuremax system, consisting of ESRTM-HODTM, will operate continuously, and while operating, will reduce bacteria throughout the system. The bacterial reduction is achieved by the disinfection activity of free chlorine being generated by the Electrolytic Scale Reducer (ESR™). An additional disinfection effect is achieved as a byproduct of the Hydro Optical De-Chlorination unit (HOD™) unit. The high power unit will disinfect and dechlorinate at the same time. As there is Continues Bioburden Reduction (CBR™) though the system, there is no need to heat sanitize at short intervals, so the Biopuremax can be easily validated to PW/WFI pharmaceutical standards.

  • European Pharmacopeia (EP)

    The production of WFI with non-distillation technologies is now part of the European Pharmacopeia (EP). The EP has now harmonized with the USP that has allowed this technology for WFI production for over 30 years.
    By not installing and operating distillation equipment, the total life-cycle costs, both investment and operational, are drastically reduced.

  • ISO standard for Purified Water and WFI system equipment

    The ESR™ and HOD™ technology is now part of the ISO 22519 “Purified Water and Water for Injection system equipment” draft to be published 2018.

  • How does the Biopuremax pretreatment technology work?

    The first stage deals with the scale reduction.

    The ESR™ (Electrolytic Scale Reduction) unit is composed of a metallic, cylindrical reaction chamber, with a central electrode. Electrical current is passed from the central anode to the cylindrical cathode, through the water, which causes a high pH in the vicinity of the cathode. High pH causes scale to be deposited in the reactor.

    The ESR™ will precipitate all scale forming ions, not just magnesium and calcium but any other ions that are susceptible to high pH e.g. Silica, Ferum, Manganese etc.

    The second stage deals with free chlorine in the feed water.

    The ESR™ treated water is de-chlorinated with Hydro Optical De-Chlorination unit (HOD™), by exposure to ultra violet (UV) radiation which decomposes the oxidizer (free chlorine, chloramines, ozone  or chlorine dioxide).

    Through all the pretreatment stage the system continuously reduces the bioburden the further downstream the water progresses.

    In other systems, organic media will filter out the microbes on to fertile organic material with high surface area.

    In the Biopuremax, this will not happen as all the contact surfaces of the Biopuremax are SS 316 L or Quartz.

    Due to the high quality of the water produced by the Biopuremax pretreatment, you can generate WFI with membranes without a thermal distillation unit with high reliability and reduce drastically the investment cost as no distillation unit is required.

    Moreover, the operational cost will also be reduced drastically since the energy required while using membrane based technology in comparison to distillation is very low.
    Above all of that while using Biopuremax technology, in your water system, you will save thousands of euros on maintenance, labor hours, salt, and water consumption.