Applications
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Application
- Blood and Plasma
- Vaccine Production
Biological Information
Compliance Information
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Bacterial Endotoxins
< 0.25 EU/mL as determined by the LAL test
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Biological Reactivity
All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
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Extractables
The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical)
Dimensions
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Filter Size
30"(1.8 m² / 19.4 ft²)
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Filtration Area
1.8 m² / 19.4 ft²
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Outer Diameter
70 mm
General Specifications
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Capsule/Cartridge Format
Cartridges
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Maximum Allowable Back Pressure
2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C
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Maximum Diffusion
45 mL/min at 2.5 bar | 36 psi
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Minimum Required Bubble Point
3.2 bar | 46 psi
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Vent Valve
N/A
Materials of Construction
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Filter Material
Cellulose Acetate (CA)
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Housing Material
Polypropylene (PP)
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Material o-ring | seal
Silicone (SI)
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Support Fleece
Polypropylene (PP)
Operating Conditions
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Maximum Differential Pressure
20 °C: 5 bar; 80 °C: 2 bar
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Maximum Operating Pressure
5 bar (72.5 psi)
Physicochemical Information
Product Information
Sterility
Usage Protocols
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Sterilization Procedures
- In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
- Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
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