Depth Filter
Product Introduction
Alioth Alidep® Depth Filter is mainly used for the clarification step in pharmaceutical process, and its disposable design provides greater flexibility for large-scale production.
Alidep® Depth Filter has various media combinations, and is mainly composed of cellulose, filter aids, and positively charged resins. It provides strong dirt-holding capacity and may be used for the clarification of cell culture fluid. It can progressively retain intact cells and cell fragments, reduce turbidity, and effectively absorb impurities such as DNA, HCP and endotoxins, thereby reducing the pressure in subsequent purification steps.
There are different product specifications that can meet the needs of laboratory, pilot-scale, and production-scale applications.
Product Properties
- Disposable design, and no need for cleaning validation
- Modular design, which enables adaptation to current mainstream clarification holders and systems
- Small residual volume, which allows for full recovery of target products and improves recovery rate
- Flexible media selection, which enables targeted product development based on the characteristics of material liquid
- Strict production control and release testing, reliable performance and sturdy structure, which result in lower process risk
- Easy operation, small footprint and space-saving
Typical Applications
- Clarification of CHO cell culture fluid
- Clarification in vaccine production process
- Clarification of yeast fermentation broth (after centrifugation)
- Clarification in plasmid production process (E. coli lysate)
- Clarification of lentivirus and adeno-associated virus culture fluid
- Clarification of other complex material liquids
Product Characteristics
| Product series | Alidep® process development scale (L series) |
Alidep® laboratory scale (P series) |
Alidep® production scale (M series) |
| Effective filtration area (EFA) | 23cm2 | 270cm2, 540cm2 | 0.11m2, 0.55m2, 1.1m2 |
| Overall dimension (cm) | 8.9×6.6×4.1cm | 22×14×(7.4~9.6) cm | 6 2×32×(3.4~12.7) cm |
| Inlet, outlet and exhaust port | Luer connector: Polypropylene |
6 mm hose connector: Glass fiber-filled polypropylene |
Flat end connector: Glass fiber-filled polypropylene |
| Frame and cover material | Glass fiber-filled polypropylene | ||
| Filter plate | Cellulose, filter aids and resin | ||
| Supporting layer | Polypropylene | ||
| O-ring | Silicone | ||
| Aerosol challenge test | Aerosol leakage < 0.01% | ||
| Maximum Operating Pressure | 3.5 bar @ 40℃ | ||
| Maximum forward differential pressure |
3.0 bar @ RT | ||
| Maximum reverse differential pressure |
2.0 bar @ RT | ||
| Tolerance to sterilization | Up to 2 cycles of high-pressure sterilization at 125°C for 60 minutes | ||
| Indirect food additive | The raw materials of all Alidep® Depth Filter components comply with the requirements for food additives in FDA 21 CFR 177-182 | ||
| Toxicity | The raw materials of all Alidep® Depth Filter components, including filter plates ( mainly made from cellulose, filter aids and resin ), frames and covers made from glass fiber-filled polypropylene, depth supporting nets made from polypropylene, and silicone O-rings, meet the requirements for in vivo biological safety of Class VI plastics in USP < 88 > | ||
| Bacterial endotoxin | After rinsing an Alidep® Depth Filter with 9 L / m2 purified water, the endotoxin level of rinsing liquid is < 0.25 EU/mL, which complies with the requirements for water for injection in Chinese Pharmacopoeia and United States Pharmacopoeia | ||
※The thickness of filter is related to the number of filter plate layers
Pore Size Range
| Name of medium | Application | Features | Composition |
| Double-layer HD Series | Primary clarification of cell culture fluid |
Two-stage filter plate and open pore, which can retain large particles and fragments |
Cellulose, filter aids and resin |
| Double-layer HA Series | Secondary clarification of cell culture fluid |
Double-stage filter plate and dense structure, which can achieve more strict turbidity control |
Cellulose, filter aids and resin |
| Double-layer HC Series | Direct clarification of cell culture fluid |
Double-stage filter plate, which is designed to clarify material liquid with a low cell density | Cellulose, filter aids and resin |
| Double-layer CE Series | Clarification of plasmids and virus particles, etc. |
Double-stage filter plate, which features low adsorption | Cellulose |
Pore Size Range
Conductivity Test Results
pH Test Results
TOC Test Results
Test Results of Flow Differential Pressure
Validation Methods and Results
| Conductivity | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then rinsed with 100 L/m2 pure water for 10-20 minutes. The conductivity ranged from 2.79 to 7.51 μS/cm |
| NVR | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then rinsed with 100 L / m2 pure water for 10-20 minutes. The NVR ranged from 667 to 1,314 mg |
| TOC | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then washed with 100 L / m2 pure water for 10-20 minutes. The TOC ranged from 1.12 to 1.55 mg/L |
| pH | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then rinsed with 100 L / m2 pure water for 10-20 minutes. The pH ranged from 6.10 to 6.62 |
| Endotoxin | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then rinsed with 100 L / m2 pure water for 10-20 minutes, followed by soaking in pure water for 24 hours. The endotoxin level was < 0.25 EU/mL as indicated by Tachypleus Amebocyte Lysate test |
| Flow differential pressure | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes. These filters were then rinsed with 100 L / m2 pure water for 10-20 minutes. The experiment was conducted at room temperature. After venting, the flow rate was gradually increased, and the upstream and downstream pressures were observed. Within 8 LPM, the differential pressure was < 0.6 bar |
| Tolerated liquid pressure | Several filters were randomLy selected from different production batches and subjected to high-pressure sterilization at 125°C for 60 minutes, twice. The tightness of filter was tested. High-viscosity solution was filtered to increase the upstream and downstream differential pressure of filter. The filter was subjected to forward and reverse pulse pressures at room temperature, followed by rinsing, drying and tightness challenge test. At room temperature, Alidep® Depth Filter can withstand 3.0 bar forward pressure and 2.0 bar reverse pressure |
Ordering Information
For further information, please contact us and Alioth technical team will provide a comprehensive service for your filtration process.
