Tangential flow filtration (TFF) is a filtration method in which the liquid to be filtered flows tangentially across the surface of the filter, and the filter consists of a permselective membrane. Therefore, TFF is an ideal method for fine size-based separation. In fields of food, pharmaceutical and biotechnology, TFF is widely used for concentration, diafiltration, and fractionation of biomolecules such as proteins, cells, viruses, siRNA, and others, with the potential to overcome the drawbacks of traditional filtration methods.
Polyethersulfone (PES) membrane can tolerate the irritant chemical substances used in cleaning, decontamination and disinfection. The modified PES membrane has been improved upon the traditional PES membrane, reducing non-specific binding with proteins. In addition, the modified membranes are more robust for withstanding process disturbances and extreme operating conditions. The high flux and retention performance of TanFlux® modified PES membrane ensure reduced processing time and high yield.
TanFlux® Composite Flawless RC membrane is made with regenerated cellulose on microporous substrate. Compared with traditional membrane, it has excellent toughness. The mechanical strength of composite materials enables the TanFlux® RC membrane to withstand process disturbances and extreme operating conditions. In addition, the TanFlux® RC membrane features high anti-fouling and anti-blocking performance and low protein adsorption, ensuring excellent product retention, high recovery, and high yield.
Table 1. Parameters of TanFlux® TFF Membrane
| Membrane Material | Modified PES (polyethersulfone) |
Composite Flawless RC (regenerated cellulose) |
|
| Filtration Type | Ultrafiltration | Microfiltration | Ultrafiltration |
| Molecular Weight Cutoff | 5/8/10/30/50/70/100/300/500KD | 0.1/0.22/0.45μm | 1/2/3/5/10/30/100/300KD |
| Relative Flow Rate | Fast | Medium | |
| Protein Adsorption | Low | Very low | |
| pH Range | 1-14 | 2-13 | |
| Characteristics | High flux, and good chemical compatibility | Very low protein adsorption, not prone to clogging, and resistant to organic solvents | |
Amerigo Scientific offers TanFlux® II TFF cassettes that have excellent chemical compatibility and can be compatible with various chemical cleaners, thus ensuring the safety and effectiveness of the cleaning and disinfection process of TFF systems. The TanFlux® cassettes have the consistency of performance and linear scalability among the different lots. In addition, the simplified design enables these TFF cassettes to be installed and operated quickly and easily.
The TanFlux®II TFF cassettes offer four different membrane areas for selection, including 80 cm², 0.1 m², 0.5 m², and 2.5 m². All the TanFlux®II TFF membranes are made of the same material and have the same channel structure, length, and height. This ensures that various specifications of TanFlux® membranes maintain the same performance, allowing for scale-up from 100 ml to thousands of liters. The TanFlux® cassettes are designed with a strong resin or silicone housing to protect the membrane surface from impact and potential damage.
| Membrane Area | 80cm² | 0.1m² | 0.5m² | 2.5m² |
| Processing Volume | 100mL-1L | 200mL-10L | 2L or large-scale production | 10L or large-scale production |
| Cassette Length (mm) | 207 | 205 | ||
| Cassette Width (mm) | 56 | 178 | ||
| Cassette Thickness (mm) | 4 | 15-16 | 15-16 | 70-75 |
All TanFlux® cassettes are manufactured under a quality system that complies with GMP requirements. Each batch of cassettes undergoes 100% integrity testing and visual inspection to ensure that each cassette is integral, intact in appearance, and meets the delivery quality standards. Each cassette has a unique serial number in the batch number and is accompanied by a separate quality certificate. During the automatic manufacturing process, the consistency of the membrane material is guaranteed, which ensures consistency and high repeatability from scale expansion to scale reduction and between batches.
| Product Material | Channel | Polypropylene (PP) |
| Preservation solution | 20% glycerol + 0.05M sodium hydroxide | |
| Membrane | Modified PES (polyethersulfone); Composite flawless RC (regenerated cellulose) |
|
| Housing | Silicone/Resin | |
| Operating Condition | Maximum inlet pressure | 5.5bar (80psi) at 25°C; 5bar (72.5psi) at 50°C |
| Operating pH range | 2~13 | |
| Regulatory Information | Biosafety | Meeting the requirements of USP <87> and USP <88>; biosafety test |
| Regulatory conformity | Manufactured under the quality system that meets GMP requirements. Certified to ISO 9001(2015) quality management system | |
| Integrity test | Each unit must undergo the integrity test before release | |
| Transportation and Storage Condition | Products should be stored in an environment of 0 to 30°C, avoiding freezing and high temperature (>40°C) conditions. Internal packaging bag should remain intact. | |
| Sample: Intravenous immunoglobulin (IVIG) | Conc.: 100g/L |
| Over concentrated protein Conc.: >250g/L | Final target protein Conc.: >200g/L |
| Target yield: >97% |
Figure 1. TanFlux® PES 30KD (Channel D) for concentrating IVIG
Figure 1. TanFlux® RC 30KD (Channel D) for concentrating IVIG
Both TanFlux® II PES and TanFlux® II RC can concentrate the IVIG concentration from 103 g/L to 260 g/L, with an average yield exceeding 97%. Detailed data is as follows in the table:
| TanFlux® II Cassette | IVIG | Flux (LMH) | IVIG Yield (%) | |
| Before | After | |||
| PES 30KD, Channel D | 103 g/L | 260.5 g/L | 8.2 | 97.80% |
| RC 30KD, Channel D | 103 g/L | 269.7 g/L | 7.5 | 98.30% |
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