Sartopore® Platinum 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: Hose Barb ¼“ multiple stepped | Outlet: Hose Barb ¼“ multiple stepped
  • Sterilization: Delivered sterile (autoclaved)
  • Membrane Material: Modified Polyethersulfone
  • Pack Size: 5 pieces

Price (USD):
$660.00
Item No.: 
5491307H4--OO--B
Availability: 
Pieces
5

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

Sartopore® Platinum capsules are complete and ready-to-use sterile filters for pharmaceutical and biotechnology applications. These filter cartridges utilize a heterogeneous double membrane of hydrophilized polyethersulfone and are specifically designed to meet the needs for pharmaceutical filtration. The new and innovative technologies used for these filter cartridges result in unprecedented performance data. The use of Sartopore® Platinum for the critical step of sterile filtration results in a unique combination of quality, performance and cost-effectiveness.

  • Outstanding performance data
  • Excellent wettability
  • High chemical compatibility (pH 1-14)
  • Temperature stable
  • Low non-specific protein binding
  • Low Extractables Level
  • Reliable Integrity Testing

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.

Excellent wettability

Sartopore® Platinum 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 MidiCaps® height 9 (0.26 m²) and then test it for integrity. Due to the excellent wettability, WFI consumption can be significantly reduced, which significantly reduces filtration costs.

Application

Typical filtration applications include:

  • Therapeutica
  • Biological Fluids
  • Injection solutions
  • Media
  • Buffer
  • Chemical solutions
  • Cleaning agents and disinfectants

Reliable Integrity Testing

Insufficient wetting is one of the main reasons for failing filter integrity tests. In such a case, the affected filter must be rewetted and tested. In addition to the additional costs for the additional tests, there is the risk of losing an entire production batch in the event of repeated failures. The excellent wetting behavior of Sartopore® Platinum helps to eliminate this risk. The use of Sartopore® Platinum results in unprecedented reliability in integrity testing.

Compatibility

The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14. There are no restrictions, even with regard to multiple sterilization cycles. Therefore, Sartopore® Platinum capsules are suitable for most filtration applications in the pharmaceutical and biotechnology sectors.

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 scale to large production scales.

Microbial Retention

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

Packaging

All Sartopore® Platinum capsules are delivered sterile (autoclaved) and single packaged.

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
    1/4" Multiple Stepped Hose Barb
  • Connector Outlet
    1/4" Multiple Stepped Hose Barb

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)
  • Support Fleece
    Polypropylene (PP)

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: OO

Sterility/Purity

  • Delivery Condition
    Sterile - Autoclaved
  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles