Sartopore® 2 | Cartridge | 0.45µm | 5"

Tech Support Documents
Sartopore® 2 | Cartridge | 0.45µm | 5" Sartopore® 2 | Cartridge | 0.45µm | 5"
 

  • Effective Filtration Area: 0.3 m² | 3.2 ft²
  • Pore Size: 0.8 µm prefilter | 0.45 µm final filter
  • Membrane Material: Polyethersulfone
  • Sterilization: In-line steamable | Autoclavable
  • Adapter: 2-Flange Bayonet | 226 Double O-ring
  • O-ring material: Silicone

Filter Size
Adapter
Material o-ring | seal
Price (USD):
$407.00
Item No.: 
5442506G0
Availability: 
Piece
1

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

Tutorial

Filter Cartridges & Capsules Product Tutorial

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 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.

Flexibility

Sartopore® 2 filters are available in different sizes and formats with corresponding filter areas from 4.5 cm² up to 1.8 m². Different connections allow easy integration into existing systems.

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.

Accessories Information

  • Adapter
    Bottom: 2-Flange Bayonet w. 226 double o-ring | Top: Flat

Applications

  • Application
    High capacity platform for conventional sterile filtration
  • Industry
    Pharma / Biotech
  • Modality
    • Downstream Intermediates
    • Harvest | Cell Removal
  • Scale
    Production | Large Scale

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".

Dimensions

  • Filter Size
    5"(0.3 m² / 3.2 ft²)
  • Outer Diameter
    70 mm

General Specifications

  • Capsule/Cartridge Format
    Cartridges
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C
    • 1 bar (14.5 psi) at 80°C
  • Maximum Diffusion
    12 mL/min at 1.7 bar | 25 psi at 20 °C per 10 inch element
  • Minimum Required Bubble Point
    2.2 bar | 32 psi

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
    0.45 µm
  • Pore Size Pre-filter
    0.8 µm

Product Information

  • Brand
    Sartopore® 2
  • Pack Size
    1

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