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Sartobran® T-Style MaxiCaps® 0.2µm

Sartobran® P

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

Item no.:  5238307H2--SO

Availability (ex works):  On Request

Sterilizing-Grade, 0.2 µm Rated Filters
Sartobran® P Pore size: 0.45 | 0.2 µm (heterogeneous CA double layer)

Bioburden Reduction, 0.45 µm Rated Filters
Sartobran® P Pore size: 0.8 | 0.45 µm (heterogeneous CA double layer)

Your Benefits:

  • High product yield due to ultra-low unspecific adsorption
  • Excellent filtration results especially for large, shear-stress sensitive proteins
  • Exceptional total throughput especially for blood and plasma products

Sartobran® P filters are not suitable for gamma irradiation. Please check also Filter Transfer Sets for easy integration of non-gamma filters into single-use assemblies.
For highest process flexibility all Sartobran® P filters are available for conventional or single use applications. All filter elements are available in various sizes and adapter combinations. Please review the selection guide in the supporting resources literature.

Datasheet

Sartobran ® P 0,2 µm Cartridges & MidiCaps & MaxiCaps
en 484.2 kB

Applications

  • Application
    • Blood and Plasma
    • Vaccine Production
  • Industry
    Pharma/Biotech

Biological Information

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

Compliance Information

  • Biosafety
    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".
  • GMP Compliance
    This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.

Connections (Physical)

  • Connector Inlet
    1½" Tri-Clamp 50 mm
  • Connector Outlet
    ½" Single Stepped Hose Barb

Dimensions

  • Filter Size
    20" (1.2 m² / 12.9 ft²)
  • Filtration Area
    1.2 m² / 12.9 ft²
  • Height
    616 mm
  • Outer Diameter
    170 mm (110.4 mm without Connection / Valves)

Materials of Construction

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

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 5 bar; 50 °C: 3 bar
  • Maximum Operating Pressure
    5 bar (72.5 psi)

Physicochemical Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • 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

Specifications

  • Capsule/Cartridge Format
    T-Style MaxiCaps®
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    30 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    Standard

Usage Protocols

  • Sterilization Method
    Autoclavable
  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles
MaxiCaps® Filter Holders
MaxiCaps® Filter Holders

The Sartorius Stedim Biotech MaxiCaps® holder has been specially designed to integrate MaxiCaps® into biopharmaceutical processes.

Sartoclean®
Sartoclean®

Sartoclean® family is a cellulose acetate (CA) membrane based prefilter. These filters are optimized for the protection of downstream equipment and Sartobran® cellulose acetate final filters.