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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.

     

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    • Clarification of CHO cell culture fluid

    • Clarification in vaccine production process

    • Clarification of yeast fermentation broth

    • Clarification of other material liquids

     

  • Product Specifications

    Product series 16 inch 8 cells 16 inch 10 cells 16 inch other
    Effective filtration area (EFA) 1.8m2 2.3m2 Optional
    Overall dimension (mm) 184 mm 275 mm -
    Filter Media Filter Media Cellulose, Filter Aid, Resin or Cellulose
    Frame and Supporter Glass Fiber Reinforced Polypropylene
    Stainless Steel Band 316L
    O-ring Silicone
    Particle Challenge Particle Intercept＞90%
    Max Operation Pressure 3.0 bar @ RT
    Max Pressure Differential Forward：2.0bar@RT
    Reverse：not recommended
    Endurance to Sterilization SIP: 123℃ 30min, 3cycles
    Indirect Food Additive The raw materials of all Alidep® Depth Stacked Filter components comply with the requirements forfood additives in FDA 21 CFR 177-182.
    Toxicity The raw materials of all Alidep® Depth Stacked Filter components meet the requirements for in vivo biological safety of Class VI plastics in USP <88>.
    Bacterial endotoxin 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 10-20minutes. The conductivity ranged from 5-8μS/cm.
    TOC Several filters were randomly selected from different production batches, then rinsed with 100L/m2 pure water for 10-20minutes. The TOC was about 1mg/L.
    pH Several 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.
    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.
    Endurance to Sterilization Several filters were randomly selected from different production batches, after 3 cycles of SIP at 123℃ 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 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.