Sartopore® 2 XLG | Cartridge | 0.2µm | 10"

  • Effective Filtration Area: 0.8 m² | 8.6 ft²
  • Pore Size: 0.8 µm prefilter | 0.2 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
Material o-ring | seal
Price (USD):
$734.00
Item No.: 
5442507G1
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.

Watch Training Video

Sartopore® 2 XLG is a high-performance membrane filter, offering more than just reliable sterilizing-grade filtration in biopharmaceutical processes. Its highly asymmetric membrane structure and composition of 0.8µm prefilter in front of the sterilizing-grade filter (0.2 µm pore size), boosts the filtration efficiency in downstream processing of protein-based therapies or innovative drug delivery systems like lipid nanoparticles (LNPs). Thanks to the outstanding total throughput, Sartopore® 2 XLG is also a choice for filtration after the cell harvest.

Main Applications

Focus applications include:

  • Cell culture media preparation
  • Post cell harvest filtration
  • Protein-based therapies (Downstream intermediates, form & fill)
  • Lipid nanoparticles (Downstream intermediates, form & fill)

Your Benefits

  • Increased total throughput leads to less filter consumption, less process interruptions and reduced costs
  • Increased effective filtration enables the use of smaller filters to reduce footprint and waste
  • Proven and robust membrane chemistry known from the widely established Sartopore® 2 family lowers validation effort in case of process optimization
  • Broad range of formats and sizes assures scalability and enables use of Sartopore® 2 XLG along the whole drug product lifecycle: from development to commercial processes
  • Offers secure bacterial retention according to ASTM guidelines

The XL family

The XL in its name indicates an increased effective filtration area (EFA). By using a different pleating technology, the EFAs of Sartopore ® 2 XLG filters are - depending on filter format - 30-40% higher than for the conventional Sartopore® 2 filters. This leads to higher total throughput per filter element and less filter consumption or enables the use of a smaller filter element for a process to reduce the footprint and waste.

Membrane

Sartopore® 2 XLG uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore®2 XLG 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 XLG filters are available in a wide range of filtration areas from 4.5 cm² up to 2.4 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 XLG filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore® 2 XLG 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: S-Adapter

Applications

  • Application
    High capacity platform for conventional sterile filtration
  • Industry
    Pharma / Biotech
  • Modality
    • Media Filtration
    • Buffer & Auxiliaries Filtration
    • Downstream Intermediates
    • Filtration after Virus Inactivation
    • Form & Fill
  • Scale
    Production | Large Scale

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".

Dimensions

  • Filter Size
    10"(0.8 m² / 8.6 ft²)
  • Filtration Area
    0.8 m²
  • 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
    23 mL/min at 2.5 bar | 36 psi at 20 °C per 10 inch element
  • Minimum Required Bubble Point
    3.2 bar | 46 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
  • Maximum Operating Pressure
    5 bar (72.5 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
    0.8 µm

Product Information

  • Brand
    Sartopore® 2 XLG
  • 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