Pharmaceutical water-for-injection skid with stainless distillation column, storage tanks and in-line sterilising-grade membrane filtration
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Pharmaceutical water · PW / WFI

From mains
to WFI,
in control.

Every stage that turns mains water into purified water and WFI — multi-media pre-treatment, carbon and ion-exchange protection, 0.2 µm PES filtration at pretreatment, process-water and points of use, the sterile tank breathers and the clean steam that sanitises the loop — needs protecting against bioburden and particulate. We supply the filters for each of these duties.

Explore the eleven points ↓ Talk to a pharma specialist
7days
Typical dispatch
from Hilden
0.2µm
0.2 µm PES membrane
PF-PES · LRV ≥ 7 (ASTM F838)
USPCl. VI
Materials USP <88> Class VI
PF-PT · PF-PES
135°C SIP
PF-PT vents · 30 min cycles
FDA 21 CFR 177–182
What's at stake

One breach
fails the
loop.

Bioburden excursion · endotoxin · failed integrity test · a quarantined WFI batch.

Pharmaceutical water is built up stage by stage — and every stage is a place it can be lost. Mains water carries scale, chlorine and colloidal particulate that foul the carbon bed and ion-exchange resin. Filters protect pretreatment, downstream equipment and points of use; bioburden control in the loop remains the job of the water system's design and sanitisation. WFI itself is produced by distillation or an equivalent process such as reverse osmosis with electrodeionisation (Ph. Eur. 0169 since 2017). And once the water is pure, the storage and distribution loops have to stay that way: every tank that breathes draws in airborne micro-organisms, and the clean steam that sanitises the loop must itself be filtered.

Ultrafilter has supplied filtration to pharmaceutical-water systems for decades — PF-PP depth pre-filters for pre-filtration ahead of membranes, process water and resin fines; PF-PES 0.2 µm sterilising-grade PES membrane for pretreatment, process-water and point-of-use filtration (steam in place: multiple cycles, 30 min at 135 °C (275 °F)); PF-PT sterile vents for the DI and WFI tanks, with P-BE vent filter elements as an alternative on ambient tanks; and P-GS VE sintered-stainless clean-steam filters. Each element ships with its datasheet and FDA 21 CFR 177–182 materials conformity; validation guides for PF-PP, PF-PES and PF-PT are available on request; USP <88> Class VI materials for PF-PT and PF-PES.

Your water system · eleven filtration points

Find your point.
We spec the filter.

From multi-media pre-treatment and the carbon-bed / ion-exchange / UV protection filters through the final 0.2 µm membrane polish to the sterile DI and WFI tank vents, the culinary-steam filters and the loop-return membranes — the full PW/WFI build-up on one live schematic. Hover a point to preview it; click to pull the risk, the exact Ultrafilter element and a one-tap quote into the read-out.

UF-PW-WFI-LINE · live schematic
Computing layout…
Gas · sterile vent Liquid · water Steam · SIP Utilities
Point read-out
Select a point
on the line.

Each of the eleven markers is a real filtration duty on the pharmaceutical-water build-up. Pick one — the read-out shows what's at risk, the exact Ultrafilter element and how to spec it.

    The PW/WFI stack

    Five product lines.
    One water system.

    Every filtration duty in your plant is covered by one of these product families. Each ships with its datasheet and conformity documentation. Validation guides for PF-PP, PF-PES and PF-PT are available on request.

    PF-PES PES membrane filter cartridge
    PES membrane
    PF-PES
    Aqueous sterile membrane

    0.2 µm asymmetric PES membrane for pretreatment, process-water and point-of-use filtration. LRV ≥ 7 (ASTM F838); materials USP <88> Class VI.

    0.2 µm · LRV ≥ 7 →
    PF-PP polypropylene depth pre-filter cartridge
    Depth pre-filter
    PF-PP
    Depth pre-filter

    Polypropylene depth pre-filters in 5 / 2 / 1 µm grades for pre-filtration ahead of membranes, process water and resin fines.

    5 / 2 / 1 µm depth →
    PF-PT hydrophobic PTFE membrane filter cartridge
    Sterile tank vent
    PF-PT
    Hydrophobic vent membrane

    Hydrophobic ePTFE 0.2 µm sterile breather for DI and WFI tank venting. Up to 100 forward steam cycles of 30 min at 135 °C, integrity-testable in place.

    ePTFE · SIP 135 °C · up to 100 cycles →
    P-BE wound borosilicate sterile vent vent filter elements
    Tank vent alternative
    P-BE
    Sterile vent filter

    Wound borosilicate vent filter, 99.99998 % related to 0.2 µm, min. 100 sterilisation cycles — the alternative sterile vent on ambient tanks, fitted in P-BE vent housings.

    99.99998 % related to 0.2 µm →
    P-GS VE welded end-cap steam filter element
    Steam · SIP
    P-GS VE
    Steam filter

    Sintered 316L steam filter, welded end caps — 1, 5 or 25 µm grades, retention efficiency 98 % for steam — for clean steam to the storage and distribution loops.

    To 210 °C · welded caps →
    PW/WFI compliance
    Audit-ready.
    Documented.

    Each element ships with its datasheet and FDA 21 CFR 177–182 materials conformity; USP <88> Class VI materials for PF-PT and PF-PES — the documentation your QA and validation teams need.

    ASTM F838
    0.2 µm grade · PF-PT, PF-PES
    USP <88>
    Class VI · PF-PT, PF-PES
    21 CFR 177–182
    FDA · membrane materials
    ISO 9001
    2015 · quality

    Designing a new
    water system?

    Send us a P&ID, a flow rate, or just the duty — pre-treatment, carbon and ion-exchange protection, the 0.2 µm PES membrane stage, sterile DI/WFI tank venting or the clean-steam filters. We help size the train and supply the documentation for each element.

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