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Sartolon® MaxiCaps®

Sartolon filters are designed for broad chemical compatibility for specific applications in the pharmaceutical and chemical industry. The double-layer design leads to superior filtration performance compared to other nylon membrane filters and thereby allows more economical design of your filtration process. Sartolon filter elements are ideal for filtration of a broad range of solvents and solvent-containing liquids.

Item no.:  5107307H1--OOIT

Availability (ex works):  On Request

Sterilizing-Grade, 0.2 µm Rated Filters

Sartolon
Pore size: 0.45 | 0.2 µm (heterogeneous Polyamide double layer)

Your Benefits:

  • High chemical compatibility for the filtration of solvents
  • High filter capacity by in-built pre-filter (double-layer construction)
  • Excellent performance for oily formulations
  • Highly economic solution e.g. for antibiotics processes

For highest process flexibility all Sartolon 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

Sartolon ® 0,2 µm Cartridges & Midicaps & MaxiCaps
en 619.8 kB

Applications

  • Application
    Filtration of antibiotics and organic solvents
  • 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
    ½" Single Stepped Hose Barb
  • Connector Outlet
    ½" Single Stepped Hose Barb

Dimensions

  • Filter Size
    10" (0.6 m² / 6.5 ft²)
  • Outer Diameter
    137 mm (110 mm without Connection / Valves)

Materials of Construction

  • Housing Material
    Polypropylene (PP)
  • Material Prefilters
    Nylon (NY)
  • 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
    MaxiCaps®
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    13 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.0 bar | 43.5 psi
  • Vent Valve
    IT Compatible

Usage Protocols

  • Sterilization Method
    Autoclavable
  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
MaxiCaps® Filter Holders

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

Sartofluor®

Sartofluor® is the solution for all applications where sterile air is needed. A single-layer PTFE membrane construction ensures validated sterility, while providing maximum flow rate over a wide range of operating conditions. The optimal performance-to-cost ratio allows benefiting from the lowest cost-of-ownership for air/gas and aggressive solvent filtration.