Sartopore® 2 is the industry standard of high-performance polyethersulfone (PES) liquid filters. A broad variety of different pore size combinations ensures highly economic and safe filtration performance. From single-layer high flow solutions to specific Mycoplasma retentive filters, Sartopore®2 perfectly adapts to your specific process needs.

Item No.: 
5442107H1

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

Sterilizing-Grade, 0.2 µm Rated Filters

Sartopore®2 HF Pore size: 0.2 µm (single layer)
Sartopore®2 Pore size: 0.45 | 0.2 µm (heterogeneous PES double layer)
Sartopore®2 XLG Pore size: 0.8 | 0.2 µm (heterogeneous PES double layer)
Sartopore®2 XLIPore size: 0.35 | 0.2 µm (heterogeneous PES double layer)

It is the identical final 0.2 µm membrane layer which ensures sterility of your product. But it is the pre-filter porosity which makes the difference. Depending on specific product properties a finer or coarser pre-filter layer can significantly improve the capacity of the filter. Quasi particle-free liquids like buffer solutions can be filtered without any pre-filter layer for increasing the flow performance.

If a new process is designed or existing processes are optimized, Sartopore® 2 allows cost reduction of up to 90%. The best-performer of your specific application can be easily identified by Increase® filterability trials. Make use of this service to understand the benefit for your filtration process.

Your Benefits:

  • Lowest filtration costs (highest filter capacity)
  • Various filter solutions within one platform (identical materials used for your process)

Mycoplasma-Retentive, 0.1 µm Rated Filters

Sartopore®2 XLM Pore size: 0.2 | 0.1 µm (heterogeneous PES double layer)

It is well known that Mycoplasma can be present in commercially available cell culture media. Because Mycoplasma are able to penetrate 0.2 µm rated sterile filters, the industry specifically developed finer filter membranes (0.1 µm) for the successful retention of Mycoplasma.

It is the highly asymmetric structure and the perfect fit between the 0.2 µm prefilter layer and the 0.1 µm final membrane which ensures an unmet combination of highest safety and highest filtration capacity. Sartopore® 2 XLM is the most powerful filter in the market and is fully validated as sterilizing grade filter (according to ASTM…) and Mycoplasma removal.

Your Benefits:

  • Lowest filter consumption by high filtration capacity
  • Lowest risk of Mycoplasma contamination for you fermentation process
  • Perfect fit to Sartopore® 2 used in other process steps

Bioburden Reduction, 0.45 µm Rated Filters

Sartopore®2 Pore size: 0.8 | 0.45 µm (heterogeneous PES double layer)

Sartopore®2 0.45 µm rated filter cartridges are designed for bioburden reduction and particle removal from a broad range of pharmaceutical products. They offer extremely high flow rates and total throughputs and are therefore ideally suited for membrane prefiltration of aqueous solutions and highly viscous, difficult to filter pharmaceutical products.

For highest process flexibility all Sartopore®2 filters are available for conventional or single use applications. All filter elements are available in various sizes and adapter combinations. Please review the selection guide in the supporting resources literature.

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
    Double Open End with Flat Gaskets (21)  
  • Connector Outlet
    Double Open End with Flat Gaskets (21)  

Dimensions

  • Filter Size
    10"(0.6 m² / 6.5 ft²)  
  • Filtration Area
    0.6 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
    18 mL/min at 2.5 bar | 36 psi at 20 °C per 10 inch element  
  • 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)  
  • 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
    1  
  • Type
    10" | Adapter 21  

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  
  • Liquid Filter Housings
    Item no.
    M_Liquid_Filter_Housings

    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.

  • Sartocheck® 5 Plus Filter Tester
    Item no.
    26787---FT---P

    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
    Item no.
    M_Sartoguard

    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.