ATF Hollow Fiber Filter for Perfusion Cell Culture Process, 1/pk
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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/fiber 3-8 L/min/m² |
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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 Test
Meets 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
- CobetterBiophsep_Hollow_Fiber_Modules_20250627 Download