Sartopore® 2 XLG Cartridge 10"

Sartopore® 2 XLG filter cartridge is a high-performance PES membrane filter, used in stainless steel housings, to perform sterilizing-grade filtration in bioprocesses. Its unique membrane composition boosts the filtration efficiency in downstream processing of proteins or lipid nanoparticles.

Pore Size: 0.8 µm | 0.2 µm

Item No.: 
5442507G1

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

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.

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.

Sartopore® 2 XLG filters are available in all established formats with different sizes and for different purposes: Conventional filter cartridges for stainless steel housings or single-use capsules like the small Capsules, the mid-sized Midicaps®, the larger Maxicaps® / T-Style Maxicaps® and the Maxicaps® MR for very large volumes (e.g, clarification after bioreactor harvest). The single-use capsules are available as pre-sterilized (by autoclaving), autoclavable or gamma irradiatable versions. The wide range of different filter formats and sizes ensures that customers can easily scale up their process during drug development process – from preclinical to commercial scale.

Focus Applications

  • 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

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
    2-Flange Bayonet Adapter with 226 Double O-ring (25)  
  • Connector Outlet
    2-Flange Bayonet Adapter with 226 Double O-ring (25)  

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  

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

  • 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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    Item no.
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    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.