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Sartopore® Platinum Gamma MidiCaps®

Sartopore® Platinum is the high performance polyethersulfone (PES) filter platform from Sartorius Stedim Biotech. The innovative surface modification of the membrane leads to excellent wettability. Therefore, this filter family is perfectly suited for modern single-use applications, making processes highly economic, user friendly and safe. Using Sartopore® Platinum you will benefit from this cutting-edge membrane technology.

Item no.:  5495307H7G-SS--A

Availability (ex works):  On Request

Pore Size: 0.45 | 0.2 µm (heterogeneous PES double layer)

Sartopore® Platinum family is the best-wetting filter platform on the market, eliminating any potential wetting induced issues during integrity testing. The perfect wettability of the modified PES double layer membrane leads to significant reduction of the required flushing volume (up to 95% less water needed), which is highly beneficial for single-use processes. Our Sartopore® Platinum family offers the lowest protein adsorption of any PES membrane on the market to maximize product yield. Moreover, our innovative pleating technology (TwinPleat) results in large-area capsules (1 m² filtration area per 10”) to filter large batch sizes with a single device.

Sartopore® Platinum HB is a specific filter type with a higher Bubble Point to ensure highest process safety. This filter is our recommended solution for challenging processes such as fill & finish applications.

Features & Benefits

  • Lowest protein adsorption – maximizing product yield
  • Excellent wettability – up to 95% less water needed
  • No wetting issues during integrity testing – preferred for single-use assemblies
  • Highest effective filter area (1 m²/10”) – less filter consumption

For highest process flexibility Sartopore® Platinum filters are offered for conventional and single-use applications. Our filter elements are available in multiple configurations regarding filtration area and adapter combinations. Please review the selection guide in the supporting literature.

Datasheet

Datasheet Sartopore® Platinum
en 913.9 kB

Applications

  • Application
    Single Use Processing
  • 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 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
    1½" Tri-Clamp 50 mm

Dimensions

  • Filter Size
    size 7 (0.065 m² / 0.7 ft²)
  • Filtration Area
    1 m²
  • Height
    115 mm
  • Outer Diameter
    108.5 mm (77 mm without Connection / Valves)

Materials of Construction

  • Housing Material
    Polypropylene (PP)
  • Material Prefilters
    Polyethersulfone (PES), asymmetric
  • Material o-ring | seal
    Silicone (SI)
  • Support Fleece
    Polyester (PET)

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
  • Bubble Point
    ≥ 3.5 bar | 51 psi
  • 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

  • Filter Type
    Liquid Filters

Specifications

  • Capsule/Cartridge Format
    MidiCaps®
  • Maximum Allowable Back Pressure (at 20°C)
    2 bar / 29 psi at 20°C; 1.5 bar / 21.8 psi at 50°C
  • Maximum Diffusion
    4 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.5 bar
  • Vent Valve
    Standard

Usage Protocols

  • Sterilization Method
    Gamma Irradiatable
  • Sterilization Procedures
    Gamma Irradiation: with 50 kGy, 1 Cycle