Sartopore® 2 XLI | Cartridge | 0.2µm | 10"

  • Effective Filtration Area: 0.8 m² | 8.6 ft²
  • Pore Size: 0.35 µm prefilter | 0.2 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
Material o-ring | seal
Price (USD):
$886.00
Item No.: 
5442507I1
Availability: 
Piece
1

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

  • Specially designed for sterile filtration of pharmaceutical solutions with a homogeneous particle spectrum
  • Unique heterogeneous double-layer PES membrane combination
  • Specifically designed to ensure exceptionally high total flow and flow rates for the entire chemical process fluids and other process fluids of the small particle spectrum biotech manufacturing processes

Main Applications

Focus applications include:

  • Ophthalmic solutions
  • Chemically defined cell culture media
  • Large volumes of highly viscous parenterals
  • Any completely chemically defined medium

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 XLI 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 XLI 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 XLI uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore®2 XLI 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 combination of the built-in 0.35 μm pre-filter in front of a 0.2 μm final filter together with an exceptionally high effective filtration area enables outstanding overall flow and flow rate performance in the target applications. This ensures maximum process efficiency, minimized filtration costs and short filtration times.

Flexibility

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

Documentation:

Sartopore® 2 XLI 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
    • Buffer & Auxiliaries 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
    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
    21 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
    0.35 µm

Product Information

  • Brand
    Sartopore® 2 XLI
  • 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
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