Depth Filters
Product Characteristics
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Product Specifications |
Product Series |
Alidep® process development scale (L series) |
Alidep® laboratory scale (P series) |
Alidep® production scale (M series) |
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Effective Filtration Area |
23 cm2 |
270 cm2、540 cm2 |
0.11 m2、0.55 m2、1.1 m2 |
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Overall Dimension |
9.4x7.1x4.3 cm |
22x14x(7.4~9.6) cm |
62x32x(3.1~12.4) cm |
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Materials of Construction |
Inlet, Outlet and Exhaust Port |
Luer connector: Polypropylene |
6 mm hose connector: Glass fiber-filled polypropylene |
Flat end connector: Glass fiber-filled polypropylene |
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Frame and Cover Material |
Glass fiber-filled polypropylene |
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Filter Plate |
Cellulose, filter aids and resin |
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Supporting Layer |
Polypropylene |
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O-ring |
Silicone |
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Working characteristics |
Aerosol Challenge Test |
Aerosol leakage < 0.01% |
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Maximum Operating Pressure |
3.5 bar @ 40°C |
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Maximum Forward Differential Pressure |
3.0 bar @ 25℃ |
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Maximum Reverse Differential Pressure |
2.0 bar @ 25℃ |
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Sterilization Resistance |
Autoclave: 125℃ 60 min，2cycles |
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Indirect Food Additive |
All component materials meet the requirements of Indirect Food Additive cited in FDA 21 CFR 177-182 |
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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 biological safety requirements refering to USP <88> Class VI plastic |
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Bacterial Endotoxin |
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 |
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※The thickness of filter is related to the number of filter plate layers
Pore Size Range
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Name of medium |
Application |
Features |
Composition |
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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 |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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Endotoxin |
Several filters were randomly selected from different production batches, then rinsed with 100L/m2 pure water for 10-20minutes, followed by soaking in pure water for 24 hours. The endotoxin level was <0.25 EU/mL as indicated by Tachypleus Amebocyte Lysate test |
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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 |
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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 |
