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Sartopore® Platinum Gamma Midicaps®

 
Sartopore® Platinum Gamma Midicaps® Sartopore® Platinum Gamma Midicaps®

Sartopore® Platinum is the latest polyethersulfone (PES) filter platform from Sartorius Stedim Biotech. The result of an innovative surface modification technology is a filter which is highly suitable for modern single-use applications, making the processes highly economic, user friendly and safe. Using Sartopore® Platinum you will benefit from cutting-edge membrane technology.

Item no.:  5495307H7G-HH--A

 

* 72 Hours Turnaround Time

Choose your Sartopore® Platinum

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

Sartopore® Platinum, the best-wetting filter in the market, abolishes any potential wetting induced issues with integrity testing. And the perfect wettability of the new PES membrane leads to drastic reduction of the required flushing volume (up to 95% less water needed) which is highly beneficial for single-use processes. On top of it the new technology created a new membrane with the lowest protein adsorption of any PES membrane in the market by which your product yield can be maximized.
Moreover, the new pleating technology (TwinPleat) results in large-area capsules (1 m² filtration area per 10”) by which larger batch sizes can be filtered by a single device. This highly simplifies the handling of single-use assemblies.

Your Benefits:

  • Smaller filters, less filters - highest effective filter area (1 m²/10”)
  • Smaller dimensioning of assemblies – smaller bags, less tubing, hardware
  • No risk of wetting issues and re-testing
  • High filtration capacity by proven asymmetric PES membrane and perfect fit between pre- and final filter layer

For highest process flexibility all Sartopore® Platinum 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.

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.

Dimensions

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

General Specifications

  • Capsule/Cartridge Format
    Midicaps®
  • Maximum Allowable Back Pressure
    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 | 51 psi
  • Vent Valve
    Standard

Materials of Construction

  • Housing Material
    Polypropylene (PP)
  • Material o-ring | seal
    Silicone (SI)
  • Support Fleece
    Polyester (PET)

Operating Conditions

  • Maximum Operating Pressure
    5 bar (72.5 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

  • Filter Type
    Liquid Filters

Usage Protocols

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