Depth Stacked Filter
Product Specifications
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Product Specifications |
Product Series |
16 inch 8 cells |
16 inch 10 cells |
16 inch other |
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Effective Filtration Area |
1.8 m2 |
2.3 m2 |
Optional |
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Height |
184 mm |
275 mm |
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Materials of Construction |
Filter Media |
Filter Media Cellulose, Filter Aid, Resin or Cellulose |
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Frame and Supporter |
Glass Fiber Reinforced Polypropylene |
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Stainless Steel Band |
316L |
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O-ring |
Silicone |
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Working characteristics |
Particle Challenge |
Particle Intercept>90% |
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Max Operation Pressure |
3.0 bar @ 25℃ |
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Max Pressure Differentialal |
Forward：2.0 bar @ 25℃ Reverse：not recommended |
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Sterilization Resistance |
In-line steam: 126℃ 30 min, 3 cycles |
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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 Stacked Filter components 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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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, then rinsed with 100L/m2 pure water for 10-20 minutes. The conductivity ranged from 5-8 μS/cm. |
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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. |
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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. |
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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. |
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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. |
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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. |
