Depth Filters

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.

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Depth Filters DataSheet

Application Note: Scalability Studies for Alioth Alidep® Depth Filters

Application Note: Impurity Adsorption Studies for Alioth Alidep® Depth Filters（I）

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• 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
• 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)	9.4×7.1×4.3cm	22×14×(7.4~9.6) cm	62×32×(3.1~12.4) 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