Sartopore® Platinum HB Gamma Midicaps®

Sartopore® Platinum HB (High Bubble Point) is the latest addition to the Sartopore® Platinum family. It offers the same superior performance as the standard version with an increased Bubble Point for challenging processes. This special type of filter is our recommended solution for fill & finish applications. The tighter membrane pores provide highest safety and reliability in sterile filtration.

Item No.: 
5495307H0G-OOHBV
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

Pore Size: 0.45 | 0.2 µm (High Bubble Point)

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

  • High Bubble Point (≥ 4.1 bar) – increased process safety
  • 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 HB 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.

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

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • Biological Reactivity
    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".

Connections (Physical)

  • Connector Inlet
    1/2" Single Stepped Hose Barb
  • Connector Outlet
    1/2" Single Stepped Hose Barb

Dimensions

  • Filter Size
    size 0 (0.52 m² / 5.6 ft²)
  • Filtration Area
    0.52 m²
  • Outer Diameter
    108.5 mm (77 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Midicaps®
  • Filter Format
    Capsules
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    14 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    4.1 bar | 59.5 psi
  • Vent Valve
    Standard

Materials of Construction

  • Filter Material
    Polyethersulfone (PES)
  • Material o-ring | seal
    Silicone (SI)

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 5 bar, 50 °C: 3 bar
  • 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

  • Brand
    Sartopore® Platinum

Sterility/Purity

  • Delivery Condition
    Sterile - Gamma irradiated
  • Sterilization Method
    Gamma Irradiatable

Usage Protocols

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