Depth filters retain particles and impurities throughout the entire depth of the porous structure through the combination of size and intermolecular interactions. Depth filtration is usually used for clarifying fermentation solutions, removing cell debris and DNA, and pre-treating plasma products and other biological products. Depth filtration can be used either alone or in combination with centrifugation. Compared with centrifugation, depth filtration is usually more effective in removing smaller debris and cell membrane fragments. Depth filtration is also widely used to improve the performance of subsequent filtration steps, most commonly as a pre-filter before sterile filtration or virus removal filtration. Many depth filters can directly remove viruses and antibody aggregates through adsorption.
Amerigo Scientific offers SaiClear® depth filters that are specifically designed for the demanding clarification applications in the biotechnology and pharmaceutical industries. The use of SaiClear® depth filters significantly reduces the difficulty of downstream purification processes. SaiClear® P Series and S Series depth filters with different accuracy and models are available to meet different process requirements.
Our SaiClear® depth filters have small footprints, saving space in the cleanroom. Compared with traditional depth filtration systems, SaiClear® has more flexible installation position, and is easy to operate, and convenient for process development. We also provide various specifications of deep holders, suitable for packaging filters of different specifications. Compared with similar products on the market, our holders can precisely adjust the pressure level.
Category | Product Name |
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SaiClear® S Series | SaiClear® Depth Filter, S01/15 Filter Material |
SaiClear® Depth Filter, S29/32 Filter Material | |
SaiClear® P Series | SaiClear® Depth Filter, P01/02/10 Filter Material |
SaiClear® Depth Filter, P17/20 Filter Material | |
Depth Filtration Holders | Depth Filtration Pilot Scale Holder |
Depth Filtration Production Grade Holder |
Figure 1. Filtration accuracy of SaiClear® depth filters (S/P series filter material)
Specification | 23 cm² | 100 cm² | 250 cm² | 480 cm² | 1000 cm² | 0.45 m² | 0.9 m² | |
Filter type | Capsule filter | Plate filter | ||||||
Equipment size | Diameter (mm) | 63.8 | 94 | 94 | 94 | 94 | 442 | 442 |
Height (mm) | 51 | 143 | 203 | 331 | 578 | 106 | 147 | |
Connection | Luer | TC25 | TC50 | |||||
Application | R&D | Pilot scale | Production | |||||
Processing volume | 0-5L | 1-20L | 20-2000L | |||||
Material | Membrane | Diatomaceous earth, cellulose | ||||||
Housing | Polypropylene | |||||||
Integrity test | No gas leakage, aerosol permeability meeting the requirements | |||||||
Pressure test | 25°C water bath, maintaining 50psi pressure for 24 hours, no gas leakage from filter; 40°C water bath, maintaining 40psi pressure for 24 hours, no gas leakage from filter |
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Hydraulic stress test | Rinse the filter at 40psi for 30 minutes and repeat this cycle four times before the filter passes the integrity test | |||||||
TOC | TOC value ≤6mg/L (After rinsing with 100L/m² volume of purified water, sample the filtrate.) | |||||||
Conductivity | Conductivity value ≤15μS/cm (After rinsing with 100L/m² volume of purified water, sample the filtrate. ) | |||||||
Bacterial endotoxin | The content of endotoxin in the filtrate was less than 0.25EU/mL | |||||||
Biosafety testing | The used materials meet USP <87> and USP <88> biosafety requirements |
The purpose of clarification is to effectively separate the cells, cell debris and other colloidal substances in the harvest solution, thereby providing an impurity-free feed solution for downstream purification. Clarification of cell harvest solution is the first step in middle and downstream purification of biopharmaceutical processes. It usually employs a combination of centrifugation, tangential flow filtration, flocculation, and depth filtration. The clarification filtration of cell harvest solution usually uses two grades of depth filters: in the first-grade clarification, a filter medium with a large pore size is used to remove cells or cell debris; in the second-grade clarification, a filter medium with a tight pore size is used to remove colloidal impurities.
In this filtration application, the initial turbidity of the recombinant protein cell harvest solution was 4,851 NTU, the cell density was 35.9×10⁶ per milliliter, the cell survival rate was more that 82%, and the solid content was 12.7%. After the first clarification using the SaiClear® P20 filter and the second clarification using SaiClear® S10 filter, the final turbidity of the filtrate was less than 10 NTU.
Figure 2. SaiClear P20 used for the first clarification
Figure 3. SaiClear S10 used for the second clarification
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