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AliothBio

Depth Stacked Filter

The Alioth Alidep® Depth Stacked Filters are designed primarily for clarification steps in pharmaceutical processes and are used in conjunction with stainless steel filter housings. Available in a variety of sizes, the filters offer flexibility to meet diverse customer requirements. These depth filters feature multiple media combinations, typically composed of cellulose, filter aids, and positively charged resins—or in some configurations, pure cellulose. This construction enables high throughput and efficient performance in cell culture clarification. The filters provide gradual retention of cells and cell debris, effectively reducing turbidity while adsorbing impurities such as DNA, host cell proteins (HCP), and endotoxins. This helps alleviate the burden on downstream purification steps.

Key Features and Benefits

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.

Typical Applications

Clarification of CHO cell culture
Clarification in vaccine production process
Clarification of yeast fermentation broth
Clarification of other liquid material

Product Specifications

Product Specifications

pecificationsProduct Series16 inch12 inchOther Custom Specifications
Effective Filtration Area Per Layer0.23 m20.11 m2Optional
Represents Product HeightDouble-layer membrane: 8 layers – 184 mm; 10 layers – 275 mm Single-layer membrane: 10 layers – 258 mm; 16 layers – 275 mm
Materials of ConstructionFilter MediaCellulose, Filter Aid, Resin or Cellulose
Frame and SupporterGlass Fiber Reinforced Polypropylene
Stainless Steel Band316L
O-ringSilicone
Working characteristicsParticle ChallengeParticle Intercept>90%
Max Operation Pressure3.0 bar @ 25℃
Max Pressure DifferentialalForward:2.0 bar @ 25℃ Reverse:not recommended
Sterilization ResistanceSteam-In-Place: 126℃ 30 min, 3 cycles
Indirect Food AdditiveAll component materials meet the requirements of Indirect Food Additive cited in FDA 21 CFR 177-182
ToxicityThe raw materials of all Alidep® Depth Stacked Filter components meet the biological safety requirements refering to USP<88> Class VI plastic
Bacterial EndotoxinThe 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

Validation Summary

ConductivitySeveral 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.
TOCSeveral filters were randomly selected from different production batches, then rinsed with 100L/m2 pure water for 10-20 minutes. The TOC was about 1mg/L.
pHSeveral filters were randomly selected from different production batches, then rinsed with 100L/m2 pure water for 10-20minutes. The pH ranged from 6.6-6.8.
EndotoxinSeveral 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.
Endurance to SterilizationSeveral 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 StressSeveral 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 30min. 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.

Resource Downloads

Alidep® Depth Stacked Filter.pdf

PDF · 628.46 KB · Published on 2026-05-11

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