Sartobran - 2 Pages

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Sartobran® P 0.2 μm Sterilizing Grade Filter Cartridges Specifications Materials Membrane Filter Cartridges Prefilter Membrane: Cellulose Acetate Endfilter Membrane: Cellulose Acetate Support Fleece: Polypropylene Core: Polypropylene End Caps: Polypropylene O-Rings: Silicone (optional EPDM or Viton) Pore Size 0.45 μm + 0.2 μm Available Sizes|Filtration Area Description Sartobran® P sterilizing grade filter cartridges have proven throughout the years to be the first choice in the bio-pharmaceutical industry for all applications requiring low adsorption capabilities. The unique ultra low unspecific binding capacity of the cellulose acetate membranes assures highest protein yield and rapid preservative recovery. Sartobran® P filters are ideally suited for processing high value biological solutions like dilute protein solutions and pharmaceuticals sensitive to adsorption like dilute preservative solutions. Applications Sartobran® P filters are ideally suited for all applications that require highest product recovery rates like: – Coagulation Factors, Albumine, IgG – Bacterial and Viral Vaccines – MAB's – Bio-processed Pharmaceuticals – Diagnostics – Purified Protein Solutions – Biological Fluids – Solutions containing Preservatives Highest Product Yield The Sartobran® P's cellulose acetate membrane provides the lowest unspecific adsorption of any membrane material available, ensuring the highest product recovery rates. Performance Due to the “built-in prefiltration” by a 0.45 μm membrane, Sartobran® P 0.2 μm filters provide excellent total throughputs and higher flow rates at low differential pressure for gentle product treatment. Flexibility Sartobran® P 0.2 μm filters are available in traditional cartridge formats and disposable capsules from 150 cm2 to 1.8 m2 for simple linear scale up and process flexibility. Microbiological Retention Sartobran® P 0.2 μm rated filter cartridges are fully validated as sterilizing grade filter elements according to HIMA and ASTM F-838-05 guidelines. Quality Control Each individual element is integrity tested by diffusion and bubble point test prior to release, assuring absolute reliability. Documentation Sartobran® P cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements. Cartridges Size 0 Size 1 Size 2 Size 3 5” 10” 20” 30” Mini Cartridges Size 7 Size 8 Size 9 0.3 m2 |3.2 ft2 0.6 m2 |6.5 ft2 1.2 m2 |12.9 ft2 1.8 m2 |19.4 ft2 0.05 m2 |0.54 ft2 0.1 m2 |1.1 ft2 0.2 m2 |2.2 ft2 Available Adapters Cartridges 21, 25, 27, 28 Available Adapters Mini Cartridges 15, 18 Operating Parameters Max. Allowable Differential Pressure: 5 bar |72.5 psi at 20°C (Cartridges) 2 bar |29 psi at 80°C (Cartridges) Max. Allowable Back Pressure: 2 bar |29 psi at 20°C

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Water Flow Rates for Standard Cartridges Specifications Extractables Sartobran® P 0.2 μm rated filter cartridges meet, or exceed the requirements for WFI quality standards set by the current USP. Differential Pressure [bar] 1 10” 0.8 Regulatory Compliance 100% Individually integrity tested 0.4 Non-pyrogenic according to USP Bacterial Endotoxins 30” 0.6 Integrity test correlated to HIMA/ASTM F 838-05 Bacteria Challenge Test 20” 0.2 0 Passes USP Plastics Class VI Test 0 2000 4000 Flow Rate [l/h] Non-fiber releasing according to 21 CFR 6000 8000 Standardized at 20°C Sterilization Total...

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