Cobetter, HFEF2M20A1060A, ATF Hollow Fiber Filter for Perfusion Cell Culture Process, 1/pk

Check this product with a package size of ATF2 (1-10L) / Stainless Steel (Autoclavable) / 0.2 μm on Iright. Cobetter ATF hollow fiber product is specially developed for perfusion cell culture process. The main body of the series is made of Cobetter's self-produced polyethersulfone (PES) hollow fiber membrane filament. The raw material has been tested and validated to have the features of low E&L profile and good biocompatibility. Cobetter ATF hollow fiber product is suitable for cell culture processes such as medium exchanging, continuous cell clarifying and harvesting from 1L to 2000L culture scale, which meets the requirements from R&D to commercialization.  Cobetter ATF hollow fiber product is manufactured following strict quality control standards. The production process is carried out in accordance with the ISO9001-2015 quality management system, and is all done under ISO Class 7. Each hollow fiber products will passed the integrity test and water flux test before release. Quality documentation can be provided to help bio-pharmaceutical customers' safety production and audit requirements. Specifications ATF2 ATF6 ATF10 Culture Volume 1-10L 50-200L 200-1000L Format Stainless-steel, Single-use Membrane Polyethersulfone (PES) Pore Size 50kd, 0.2μm No. of Fibers 75 1440 6720 Effective Filtration Area 0.13 m² 2.5 m² 11 m² Length 60 cm Volume Exchange 0.1 L 1.3 L 6 L Flow Range 0.3-1.5 LPM 5-20 LPM 20-90 LPM Recommended Flow Rate 5-15 mL/min/fiber3-8 L/min/m² Features 100% product integrity test; Low bioburden, no cytotoxicity; ADCF, good biocompatibility; Portable, flexible connection to 1L-2000L single-use bioreactors Single-use format available. Gamma irradiated and ready to use. Eliminating the need for complex on-site assembly and sterilization operations, improving manufacturing efficiency; All series of hollow fiber membrane columns can withstand regular autoclaving sterilization procedures, reducing the investment of high-cost sterilization equipment; Breakthrough the limitation of cell density in batch/ fedBatch process while maintaining high cell viability. Applications Pefusion cell culture process, including: N-1 high cell density seed culturing Medium exchanging and target product harvesting in dynamic/continuous perfusion cell culturing Medium exchanging in concentrated fed-batch cell culturing Cell lysis clarification and concentration Multiple fields of cell/microbial culture including: Bio-pharmaceuticals such as antibody, vaccine and CGT Food industries such as culture meat and wine-making Quality Assurance ISO 9001:2015 quality management system ISO class 7 manufacturing site 100% product integrity test ADCF raw material，meets the requirement of FDA 21CFR177-182 indirect food additives Meets the requirement of ISO 11137 sterilization validation Meets the requirement of USP <87> in Vitro Biological Reactivity TestMeets the requirement of USP <88> Biological Reactivity Test, in Vivo for Class VI plastics Aqueous extraction contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85> Particulate matter in the product eluent meets the requirement in USP <788> for large volume parenterals Product validation guide and COA available Single-Use ATF 2 Schematic Diagram   Single-Use ATF 6 Schematic Diagram   Single-Use ATF 6 Tubing Assembly Schematic Diagram   Single-Use ATF 10 Schematic Diagram   Single-Use ATF 10 Tubing Assembly Schematic Diagram Q: What are the advantages of hollow fiber compared to cassette (flat-sheet) modules? 1. More open flow channels and relatively lower shear. 2. High packing density and large surface area per module enable a compact system footprint with minimal hold-up volume. 3. Robust handling of challenging feed streams, including high solids content or viscosity. 4. Suited for large-volume, high-flow continuous processing in drug manufacturing, such as for insulin and animal vaccines. Q: What are the applications of hollow fiber technology? Concentration and buffer exchange of viral vaccines. Concentration and diafiltration of Cell and Gene Therapy (CGT) products. Purification, concentration, and buffer exchange of mRNA products. Biomass harvesting from bacterial fermentation, and clarification/removal of cell debris from cell culture lysates. Cell retention in perfusion culture (ATF system).