Depth Stacked Filter

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Alioth Alidep® Depth Stacked Filters are primarily used for theclarification step in pharmaceutical processes, with stainless steelfilter housing to achieve filtration. There are a variety of sizes to meet the customer's use.

Depth Stacked DataSheet

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• Multiple size specifications and customized according to customer needs.

• Flexible media selection to optimize customer product development.

• Adapted to current mainstream filter housing and systems.

• Strict production control and release testing, reliable performance, and low process risk.
• Clarification of CHO cell culture fluid

• Clarification in vaccine production process

• Clarification of yeast fermentation broth

• Clarification of other material liquids

Product Specifications

Product Specifications	Product Series	16 inch 8 cells	16 inch 10 cells	16 inch other
	Effective Filtration Area	1.8 m²	2.3 m²	Optional
	Height	184 mm	275 mm	-
Materials of Construction	Filter Media	Filter Media Cellulose, Filter Aid, Resin or Cellulose
	Frame and Supporter	Glass Fiber Reinforced Polypropylene
	Stainless Steel Band	316L
	O-ring	Silicone
Working characteristics	Particle Challenge	Particle Intercept>90%
	Max Operation Pressure	3.0 bar @ 25℃
	Max Pressure Differentialal	Forward：2.0 bar @ 25℃ Reverse：not recommended
	Sterilization Resistance	In-line steam: 126℃ 30 min, 3 cycles
	Indirect Food Additive	All component materials meet the requirements of Indirect Food Additive cited in FDA 21 CFR 177-182
	Toxicity	The raw materials of all Alidep® Depth Stacked Filter components meet the biological safety requirements refering to USP<88> Class VI plastic
	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

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, then rinsed with 100L/m² pure water for 10-20 minutes. The conductivity ranged from 5-8 μS/cm.
TOC	Several filters were randomly selected from different production batches, then rinsed with 100L/m² pure water for 10-20 minutes. The TOC was about 1 mg/L.
pH	Several filters were randomly selected from different production batches, then rinsed with 100L/m² pure water for 10-20 minutes. The pH ranged from 6.6-6.8.
Endotoxin	Several filters were randomly selected from different production batches, then rinsed with 100L/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.
Endurance to Sterilization	Several filters were randomly selected from different production batches, after 3 cycles of SIP at 126℃ for 30min, filters passed air tightness, diffusion flow, hydraulic stress. Flow rate and pressure dropafter SIP met the product quality standard.
Hydraulic Stress	Several filters were randomly selected from different production batches, respectively conduct hydraulic stress test at ambient temperature and after 3 cycles of SIP at 123℃ for 30 min. High-viscosity solutions was filtered to increase the pressure drop across the filters. Apply forward pulse pressure to the filter at ambient temperature, rinseand conduct diffusion flow. Depth stacked filter can withstand 2.0bar forward pressure at ambient temperature.