Sartopore® Platinum Gamma Capsule size 4 | 5pc.

  • Effective Filtration Area: 0.021 m² | 0.22 ft²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Connectors: Inlet: Sanitary ¾“|Outlet: Sanitary ¾“
  • Sterilization: Gamma-irradiatable
  • Membrane Material: Modified Polyethersulfone
  • Pack Size: 5 pieces

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Connector explanation:

O = Hose Barb ¼“ | S = Sanitary ¾“ | N = NPT-male ¼“

Price (USD):
$726.00
Item No.: 
5491307H4G-SS--B
Availability: 
Pieces
5

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

The Sartopore® Platinum Gamma capsule sterile filters have been specifically developed to enable integration into single-use systems for biotechnological production. Gamma Capsules can be connected to flexible bag systems prior to gamma irradiation.

Membrane

Sartopore® Platinum Gamma capsule use a heterogeneous double membrane made of hydrophilized polyethersulfone, which is characterized by high performance data, excellent wettability, high chemical compatibility, high temperature stability and low protein absorption.

Compatibility

Sartopore® Platinum Gamma capsule are suitable for sterilization by gamma irradiation (≤ 50 kGy). The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14. Therefore, Sartopore® Platinum Gamma Capsules are suitable for most filtration applications in the pharmaceutical and biotechnology sectors.

New surface coating

A new hydrophilization process has been developed to permanently modify the membrane surface. In this process, a thermally extremely stable and hydrophilic polymer is applied directly to the entire surface of the membrane. This technology creates the membrane properties that are responsible for the exceptionally good wettability and low protein binding of Sartopore® Platinum, even after extreme chemical and thermal stress. As a result, multiple evaporation cycles in dry and wet conditions and in both directions are possible without negative consequences in terms of wettability and integrity testing.

Main Applications

Typical filtration applications include:

  • Biologicals
  • Pharma
  • Cell culture media (with and without serum)
  • Serum
  • Buffer

Flexibility

Sartopore® Platinum Gamma capsules are available with different connections, allowing easy integration into existing bag systems.

Excellent wettability

Sartopore® Platinum Gamma capsules are very easy to wet with the inset of very small amounts of medium. Less than 1 litre of WFI is required to reliably wet a Gamma MidiCaps® size 9 (0.26 m²). At the same time, the integrity testing of the filters becomes much more reliable due to the very good wettability. The very low volumes of the wetting liquid lead to a cost reduction of the filtration process and allow an economical design of single-use systems (e.g. size of the rinsing bag).

Scale Up:

Due to the identical performance data of the different heights in relation to square meters of filter area, Sartopore® Platinum filters are perfectly scalable from small scales to large production scales.

Microbial Retention

Sartopore® Platinum filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Packaging

All Sartopore® Platinum Gamma capsules are delivered non-sterile and double-packaged to facilitate transfer to cleanroom areas."

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
    3/4" Tri-clamp 25 mm
  • Connector Outlet
    3/4" Tri-clamp 25 mm

Dimensions

  • Filter Size
    size 4 (0.021 m² / 0.22 ft²)
  • Filtration Area
    0.021 m²
  • Outer Diameter
    63 mm (46 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Capsules Size 4&5
  • 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
    1.1 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.5 bar | 51 psi
  • Vent Valve
    Standard

Materials of Construction

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

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
    Sartopore® Platinum
  • Pack Size
    5
  • Type
    Size 4 | Connectors: SS

Sterility/Purity

  • Delivery Condition
    Non sterile - Gamma irradiatable
  • Sterilization Method
    Gamma Irradiatable

Usage Protocols

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