Sartobran® Capsule 0.2µm

Tech Support Documents
Sartobran® Capsule 0.2µm Sartobran® Capsule 0.2µm
 

Sartobran® P with its unique cellulose acetate (CA) membrane is mainly used for the sterile filtration of blood & plasma products as well as viral vaccines. The ultra-low binding feature of the membrane material leads to highest product yield. Especially large, shear-stress sensitive proteins do not lose their structure and function when filtered through this special membrane. This will improve your process output even further.

Item No.: 
5231307H4--OO--B
Availability: 
Pieces
5

*Custom/bulk order quotes are provided within 72 hours of request.

Choose your Sartobran® P

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Sterilizing-Grade, 0.2 µm Rated Filters

Sartobran® P Pore size: 0.45 | 0.2 µm (CA double layer)

Your Benefits

  • High product yield due to ultra-low unspecific adsorption
  • Excellent filtration results especially for large, shear-stress sensitive proteins
  • Ideally suited for sterile filtration of viral vaccines and blood & plasma products

Sartobran® P filters are not suitable for gamma irradiation. For easy integration of non-gamma filters into single-use assemblies, we offer a wide range of possibilities with our Filter Transfer Set solutions.

For highest process flexibility Sartobran® P filters are available for conventional stainless-steel or single-use applications. The filter elements are available in various sizes and connector combinations. Please review the selection guide in the supporting literature.

Applications

  • Application
    • Blood and Plasma
    • Vaccine Production

Biological Information

  • Bacterial Retention
    Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

Compliance Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • 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).
  • Extractables
    The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

Connections (Physical)

  • Connector Inlet
    1/4" Multiple Stepped Hose Barb
  • Connector Outlet
    1/4" Multiple Stepped Hose Barb

Dimensions

  • Filter Size
    size 4 (0.015 m² / 0.16 ft²)
  • Filtration Area
    0.015 m² / 0.16 ft²
  • Outer Diameter
    63 mm (46 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Capsules Size 4&5
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    1 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    Standard

Materials of Construction

  • Filter Material
    Cellulose Acetate (CA)
  • Material o-ring | seal
    Silicone (SI)
  • Support Fleece
    Polypropylene (PP)

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 4 bar, 50 °C: 2 bar
  • Maximum Operating Pressure
    4 bar (58 psi)

Physicochemical Information

  • Non-Fiber Releasing
    This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
  • Pore Size Final-filter
    0.2 µm
  • Pore Size Pre-filter
    0.45 µm

Product Information

  • Brand
    Sartobran®

Sterility/Purity

  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles