Sartopore® 2 XLM | Cartridge | 0.1µm | 40"

  • Effective Filtration Area: 3.2 m² | 34.4 ft²
  • Pore Size: 0.2 µm prefilter | 0.1 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
Adapter
Price (USD):
$2,740.00
Item No.: 
5442558M4
Availability: 
Piece
1

*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 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.

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.

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.

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
  • 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
    40"(2.4 m² / 25.8 ft²)
  • 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

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
    0.1 µm
  • Pore Size Pre-filter
    0.2 µm

Product Information

  • Brand
    Sartopore® 2 XLM
  • 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