Pharma & Biotech filtration
Pharma & Biotech Filtration
The line that holds.
Between batch release and recall there is a single barrier — integrity. We supply the filters that hold it.
The line that holds.
Between batch release and recall there is a single barrier — integrity. We supply the filters that hold it.
Lost batch · regulatory hold · destroyed lot · a patient who never sees the medicine.
Pharma and biotech don't buy filters — they buy validation packages. Sterile filtration on the bioreactor inlet has to arrive with documented retention, integrity-test data, a sterilisation-cycle warranty and material toxicology. Not optional. Not negotiable.
Ultrafilter builds that documentation discipline into the PF-PT, PF-PVDF, PF-PES and P-BE elements it ships. cGMP manufactured, FDA 21 CFR-compliant materials, USP <88> Class VI for the polymer membrane elements. Every module is individually integrity tested before delivery; test limits on request — so your QA team can test before and after every batch.
Every filtration duty in your plant is covered by one of these product families. Each ships with its datasheet and conformity documentation; validation guides exist for the membrane and sterile-gas elements.
Hydrophobic ePTFE membrane for sterile gas and vents: 0.2 µm sterilising grade in liquids (LRV ≥ 7). Integrity-testable. Steam-sterilisable in place.
PES membrane for aqueous process fluids and water. Grades 0.1–1.2 µm; 0.2 µm sterilising grade, LRV ≥ 7 (B. diminuta, ASTM F838). Materials meet USP <88> Class VI.
Hydrophilic PVDF membrane, specified after a chemical-compatibility review — tested against a list of acids, bases, solvents and oils (ratings on page 4 of the datasheet); verify compatibility under actual process conditions before use. Grades 0.1–1.0 µm; 0.2 µm sterilising grade, LRV ≥ 7 (B. diminuta, ASTM F838); 0.45 µm bioburden reduction.
Sterile vent element for WFI, balance and storage tanks — wound borosilicate depth media, 99.99998 % related to 0.2 µm, min. 100 sterilisation cycles.
Sintered 316L steam filter with welded end caps — clean steam for CIP/SIP, 1 / 5 / 25 µm grades, retention efficiency 98 % for steam.
Validation guides for PF-PT, PF-PVDF and PF-PES are available on request.
B. diminuta per ASTM F838, LRV ≥ 7. BCT per ASTM F838, lot data in each VG.
Every module is individually integrity tested before delivery; test limits on request.
Aqueous extraction of autoclaved filter < 0.25 EU/ml, LAL, USP <85> (PF-PVDF, PF-N6). The endotoxin value describes an extraction test of the filter. It is not an endotoxin removal rating. A positive-zeta PF-N6 option gives enhanced retention of fine particles such as endotoxins.
Materials of the polymer membrane elements (PF-PT, PF-PT-DL, PF-PES) meet USP <88> Class VI.
Materials conformity for membrane, cage, end caps and O-rings, to the FDA indirect food additive requirements, 21 CFR 177–182.
Autoclaved-filter effluent meets USP <643>/<645>/<788> (PF-PVDF, PF-N6, PF-BEV per VG); PF-PT-DL: autoclaved effluent meets USP <788>.
PF-PT: up to 100 forward steam cycles of 30 min at 135 °C; autoclave: up to 30 cycles of 50 min at 135 °C. PF-PVDF: 100 fwd + 50 rev @ 135 °C. Integrity validated pre- and post-cycle.
Manufactured in an ISO Class 8 cleanroom. Every cartridge integrity-tested before release. Lot number and serial engraved on the cage.
Each element ships with its datasheet and FDA 21 CFR materials conformity; USP <88> Class VI for the polymer membrane elements. Validation guides for PF-PT, PF-PVDF and PF-PES are available on request.
Switching is hard. We make it easy: validated equivalence documentation, side-by-side cross-reference, and a QA call to walk through the integrity-test data.
Send the P&ID, a flow rate and a target sterility class. We help size the train and supply the documentation for each element. In time. On time. Every time.