Sartopore® 2 XLM | Midicaps® | 0.1µm | Size 8 | 4pc.

  • Effective Filtration Area: 0.13 m² | 1.4 ft²
  • Pore Size: 0.2 µm prefilter | 0.1 µm final filter
  • Membrane Material: Polyethersulfone
  • Connectors: Inlet: Hose Barb ½“ single stepped | Outlet: Hose Barb ½“ single stepped
  • Sterilization: Delivered sterile (Autoclaved)

________________________

Connector explanation:

O = Hose Barb ½“ | S = Sanitary 1 ½“ | H = Hose Barb ¼“ | F = Sanitary ¾“

Size explanation:

Size 7 = 0.065 m² | Size 8 = 0.13 m² | Size 9 = 0.26 m² | Size 0 = 0.52 m²

Type
Item No.: 
5445358M8--OO--A
Pieces
4

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

Sartopore® 2 XLM is specifically designed for sterile filtration and safe mycoplasma retention in cell culture media. A long filter life is guaranteed by the extremely asymmetrical and heterogeneous PES Membrane and allows a >50% better performance compared to existing 0.1 μm filter cartridges.

  • Lowest filter consumption by high filtration capacity
  • Lowest risk of Mycoplasma contamination for your fermentation process
  • High performance 0.1 μm Mycoplasma retentive filter
  • Fully validated as sterilizing-grade filter (according to current ASTM F-838 guideline)

Main Applications

Focus applications include:

  • Cell culture media containing vegetable peptone, soy or yeast
  • Serum containing cell culture media
  • Cell Culture Media Components
  • All other cell culture media used in biotechnical production

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 XLM 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 XLM 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 XLM uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore®2 XLM filters have been developed for sterilization using autoclaving at 134°C | 2bar. The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 XLM filters ideal for filtering solutions with a high/low pH.

Economical Filtration

The built-in pre-filter membrane is specially designed to protect the 0.1 μm membrane in cell culture media filtration. The optimized membrane combination together with the exceptionally high filter area of 0.8m²/10'' filter element allow a >50% better performance compared to existing 0.1 μm filter elements, which ensures low filtration costs per litre, minimized filtration times and smallest footprint of the filtration system.

The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.

Flexibility

Sartopore® 2 XLM 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 XLM filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore® 2 XLM 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.

Applications

  • Application
    High capacity platform for conventional sterile filtration  
  • Industry
    Pharma / Biotech  
  • Modality
    Media Filtration  

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
    1/2" Single Stepped Hose Barb  
  • Connector Outlet
    1/2" Single Stepped Hose Barb  

Dimensions

  • Filter Size
    size 8 (0.13 m² / 1.4 ft²)  
  • Outer Diameter
    108.5 mm (77 mm without Connection / Valves)  

General Specifications

  • Capsule/Cartridge Format
    Midicaps®  
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C  
    • 1.5 bar (21.8 psi) at 50°C  
  • Vent Valve
    Standard  

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, 50 °C: 3 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
    0.1 µm  
  • Pore Size Pre-filter
    0.2 µm  

Product Information

  • Brand
    Sartopore® 2 XLM  
  • Pack Size
    4  
  • Type
    Size 8 | Connectors: OO  

Sterility/Purity

  • Sterilization Method
    Autoclavable  

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles  
  • 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.