Sartopore® 2 | Mini Cartridge | 0.2µm | Size 7 | 5pc.

Tech Support Documents
Sartopore® 2 | Mini Cartridge | 0.2µm | Size 7 | 5pc.
 

  • Effective Filtration Area: 0.05 m² | 0.5 ft²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Membrane Material: Polyethersulfone
  • Sterilization: In-line steamable | Autoclavable
  • Adapter: Bayonet
  • O-ring material: Silicone

Type
Price (USD):
$729.00
Item No.: 
5441507H7------B
Pieces
5

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 Cartridges have been developed for sterilization using either autoclaving or in-line-steaming. The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14.

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.

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

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
    Bayonet Adapter with O-ring (15)
  • Connector Outlet
    Bayonet Adapter with O-ring (15)

Dimensions

  • Filter Size
    size 7 (0.05 m² / 0.54 ft²)
  • Filtration Area
    0.05 m²
  • Outer Diameter
    56 mm

General Specifications

  • Capsule/Cartridge Format
    Mini Cartridges
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C
    • 1 bar (14.5 psi) at 80°C
  • Maximum Diffusion
    at 20 °C and 2.5 bar | 36 psi: 0.05 m² | 0.5 ft²: 4 mL/min; 0.1 m² | 1 ft²: 5 mL/min; 0.2 m²| 2 ft²: 7 mL/min
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    N/A

Materials of Construction

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

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 5 bar, 80 °C: 2 bar

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
    Mini Cartridge | Size 7

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable | Steamable
  • Sterilization Method
    Autoclavable & In-Line Steam Sterilizable

Usage Protocols

  • Sterilization Procedures
    • In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
    • Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
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    Sartorius Stedim Biotech Sanitary Single Round Filter Housings are specifically designed for liquid filtration applications of the Bio-Pharmaceutical Industry. Application: bioreactors, CIP skids, autoclaves, lyophilizers and process tanks.

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    Sartocheck® 5 Plus Filter Tester
    Item no.
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    The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.

  • Sartoguard
    Sartoguard
    Item no.
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    All members of the Sartoguard family utilize a highly asymmetric polyether sulfone (PES) membrane double layer for unmatched protection of final filters and bioburden reduction with an LRV of 6 per cm². In addition, combinations with different depth filter materials and gamma sterilizable versions are available.