A fermentation batch is only as clean as the streams that enter it and the gas that leaves it — the sterile feed and media, the clean steam that sanitises the vessel, the double-layer sparger air, and the exhaust filters that retain micro-organisms from the off-gas. We supply the filters that hold every one of them.
Contaminated culture · failed sterility · a blocked sparger · an uncontrolled exhaust release.
A fermentation runs for days, and every stream that touches it is a route for a contaminant that could outgrow the culture and waste the whole batch. The water, media and raw materials must enter sterile. The steam that sanitises the bioreactor must be clean steam. The air sparged through the broth — often for the full run — has to be sterilised without ever wetting out. And the off-gas leaving a live culture carries viable organisms that the exhaust filters must retain.
Ultrafilter has supplied filtration to fermentation and biotech processes for decades — PF-PES 0.2 µm sterilising-grade membrane for the feed, media and raw-material streams; P-GS VE sintered-stainless clean-steam filters; PF-PT ePTFE 0.2 µm sterile air for the sparger; the exhaust train — a 10 µm polypropylene pre-filter (PF-PP) ahead of the final PF-PT 0.2 µm ePTFE exhaust filter; and P-BE sterile vent elements for fermenter and vessel venting. Each element ships with its datasheet and FDA 21 CFR 177–182 materials conformity; the membrane elements also with a validation guide, and USP <88> Class VI for the PF-PES and PF-PT membrane elements.
Every filtration duty in your plant is covered by one of these product families. Elements ship with datasheet and FDA 21 CFR materials conformity; the membrane elements also with a validation guide.
Hydrophobic ePTFE 0.2 µm sterile-grade filter for sparger air and for the exhaust — retains micro-organisms from the off-gas of a live culture. Up to 100 forward steam cycles of 30 min at 135 °C, integrity-testable in place.
Asymmetric PES 0.2 µm sterilising-grade membrane for the process-water, media and raw-material feeds to the fermenter. LRV ≥ 7 (ASTM F838); materials meet USP <88> Class VI.
Sintered-stainless clean-steam filter with welded end caps that sanitises the bioreactor and its services — 1 / 5 / 25 µm, retention efficiency 98 % for steam. Steam filters are always sintered stainless, never a polypropylene element.
10 µm polypropylene pre-filter ahead of the final exhaust filter, protecting and extending the life of the final element.
Wound borosilicate sterile vent element for fermenter, bioreactor and process-vessel venting — 99.99998 % related to 0.2 µm, min. 100 sterilisation cycles.
Each element carries the documentation your QA and validation teams need before it ever contacts your culture, your feed or your off-gas.
Send us a P&ID, a working volume, or just the duty — sterile feed and media, the SIP steam filter, the double-layer sparger air or the exhaust filter train. We help size the train and supply the documentation for each element.