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

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Connector explanation:

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

Price (USD):
$486.00
Item No.: 
5441307H4G-OO--B

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

Sartopore® 2 Gamma Capsules were designed for connection with bag containers prior to sterilization using gamma irradiation. Sartopore® 2 Gamma capsules are ideal for producing high-quality pharmaceutical and biotechnological products in small amounts. Made from the same materials and built according to the same construction principle as all other Sartopore® 2 gamma filter elements, Sartopore® 2 Gamma Capsules are ideally suited for scale-up and scale-down experiments in R&D departments in pharmaceutical development.

  • Small pleated filter unit
  • Ideal for scale-up & scale down
  • The familiar performance properties of the Sartopore® 2
  • Excellent Flow Rates & Lifetimes
  • Broad Chemical Compatibility For Solvents

Applications

Typical applications include the sterile filtration of:

  • Pharma
  • Biologicals
  • Cell culture media
  • Culture media components
  • Serum
  • Buffer
  • Diagnostics

Compatibility

Sartopore® 2 gamma capsules have been developed for sterilization by gamma irradiation < in 50 kGy irradiation doses. The Sartopore 2 Gamma Capsule polyethersulfone membrane has a high chemical compatibility between pH 1 to 14, making Sartopore® 2 gamma capsules ideally suited for the filtration of high and low pH buffer 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 gamma capsules achieve outstanding total flow and excellent flow rates.

Easy handling

Sartopore® 2 Capsules are supplied for easy installation in any filtration system with the following connections: tube nozzle, 4 inch NPT thread or 1 inch tri-clamp connection. The tri-clamp connection guarantees reliable integrity testing.

Flexibility

Sartopore® 2 Gamma capsules are available of 0.015 m² | 0.15 ft² to 0.45 m² | 5 ft² to enable their use in any bag filtration process regardless of batch size.

Automatic venting

A hydrophobic PTFE membrane at the highest point "upstream" allows easy ventilation of the capsule and prevents product loss during venting.

Scalability

The same materials and the same construction as any other Sartopore® 2 filter elements make sure that the Satropore® 2 Capsule is ideal for use in R&D laboratories in the pharmaceutical sector. Filtrations can already be carried out with extremely small volumes of high-value products.

Microbiological Retention

Sartopore® 2 Capsules with 0.2 μm end membrane are validated as sterile filters according to HIMA and ASTM F-838-05 guidelines.

Quality

Every single element is integrity checked to meet the highest quality standards.

Documentation

Sartopore® 2 Capsules are developed and produced according to a DIN ISO 9001 certified quality management system. Validation documentation and documentation that comply with the regulatory requirements are available.

Applications

  • Application
    High capacity platform for conventional sterile filtration  
  • 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  
  • Connectors
    Hose barb 0.25" multi stepped | Hose barb 0.25" multi stepped  

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  
  • Type
    Size 4 | Connectors: OO  

Sterility/Purity

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

Usage Protocols

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