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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

 

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.

Datasheet

Sartobran® P 0.2 µm Sterilizing-Grade Filter Elements
en 447.5 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

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • 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
    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)
  • 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: 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®
  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles
Sartocheck® 5 Filter Tester
Item no.
26787---FT

The Sartocheck® 5 Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.

Sartocheck® 5 Plus Filter Tester
Item no.
26787---FT---P

The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.

Filter Holders

Wide variety of filter holders, from stainless steel or glass filter holders to polycarbonate or PTFE syringe filter holders.

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.