Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.

Tech Support Documents
Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.
 

  • Effective Filtration Area: 0.015 m² | 0.16 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: Gamma-irradiatable
  • Membrane Material: Polyethersulfone
  • Pack Size: 5 pieces

________________________________________

Connector explanation:

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

Filter Size
Sterilization Method
Connector(s)
Item No.: 
5441307H4G-OO--B
Availability: 
Pieces
5

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

Tutorial

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Watch our video tutorial to discover the essential steps for sterile filtration and master the sterilizing-grade filtration process.

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Choose your Sartopore® 2

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  • Extremely high flow rates and total throughputs
  • Number one choice for bioburden reduction & particle removal
  • Broad compatibility and easy scalability
  • Outstanding filtration performance of aqueoussolutions that are highly viscous & difficult to filter

Main Applications

Typical applications include bioburden and particle removal of:

  • Therapeutica
  • Injection solutions
  • Buffer
  • Biological Fluids
  • Tissue culture media
  • Acidic and alkaline solutions

Membrane

Sartopore® 2 uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore®2 Gamma filters have been developed for sterilization using gamma irradiation < in 50 kGy irradiation doses. The Sartopore® 2 polyethersulfone membrane has a high chemical compatibility between pH 1 to 14, making Sartopore® 2 Gamma filters ideally suited for the filtration of high and low pH solutions in pharmaceutical | Biotech Industry

Performance

A unique pleated filter construction combined with the highly asymmetrical pore structure of the membrane enables excellent flow rates and lifetimes, particularly compared to conventional flat filter systems. By means of "integrated prefiltration" in the form of a 0.45 μm membrane, the Sartopore 2 filters achieve outstanding total flow and excellent flow rates.

Cost savings:

The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.

Flexibility

Sartopore® 2 filters are available in a wide range of filtration areas from 4.5 cm² up to 1.8 m² and with a variety of commonly used connections to ensure easy integration into your process regardless of batch size.

Scale Up:

Consistent and predictable scale-up and scale-down procedures can be performed safely because all Sartopore® filter elements are manufactured with the same membrane type and construction materials.

Quality:

Every single element is tested for integrity to meet the highest quality requirements.

Microbial Retention

Sartopore® 2 filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore® 2 filters have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements.

Applications

  • Application
    High capacity platform for conventional sterile filtration
  • Industry
    Pharma / Biotech
  • Modality
    Buffer & Auxiliaries Filtration
  • Scale
    Product Development | Scale Up Filters

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
  • Connector(s)
    Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb

Dimensions

  • Filter Size
    size 4 (0.015 m² / 0.16 ft²)
  • Filtration Area
    0.015 m²
  • Outer Diameter
    63 mm (46 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Capsules Size 4&5
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C
    • 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    1 mL/min at 2.5 bar | 36 psi at 20 °C
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    Standard

Materials of Construction

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

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® 2
  • Pack Size
    5

Sterility/Purity

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

Usage Protocols

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