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Sartopore® 2 XLG MaxiCaps®

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.:  5447307G3--SS

Availability (ex works):  On 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 XLI Pore 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.

Datasheet

Sartopore® 2 XLG 0.2 μm — Sterilizing Grade Filter Elements
en 906.5 kB

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

  • Biosafety
    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".
  • GMP Compliance
    This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.

Connections (Physical)

  • Connector Inlet
    1½" Tri-Clamp 50 mm
  • Connector Outlet
    1½" Tri-Clamp 50 mm

Dimensions

  • Filter Size
    30" (2.4 m² / 25.8 ft²)
  • Height
    865 mm
  • Outer Diameter
    137 mm (110 mm without Connection / Valves)

Materials of Construction

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

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 5 bar; 50 °C: 3 bar
  • Maximum Operating Pressure
    5 bar (72.5 psi)

Physicochemical Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • 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

  • Pack Size
    1

Specifications

  • Capsule/Cartridge Format
    MaxiCaps®
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    Standard

Usage Protocols

  • Sterilization Method
    Autoclavable
  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
MaxiCaps® Filter Holders
MaxiCaps® Filter Holders

The Sartorius Stedim Biotech MaxiCaps® holder has been specially designed to integrate MaxiCaps® into biopharmaceutical processes.

Sartoguard®
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.