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Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.

Tech Support Documents
Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.
 

Designed for scale-up in the PD area, Sartopore® 2 Capsules provide seamless transition from development to production. Their versatile design supports various applications, ensuring consistent performance and reliability.

Filter Size
Sterilization Method
Connector(s)
Item No.: 
5441307H4G-OO--B
Pieces
5
*Custom/bulk order quotes are provided within 72 hours of request.
Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.
Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.

Designed for scale-up in the PD area, Sartopore® 2 Capsules provide seamless transition from development to production. Their versatile design supports various applications, ensuring consistent performance and reliability.

Item No.:
5441307H4G-OO--B
Number of pieces
5

Overview

Specifications

Choose your Sartopore® 2

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Sartopore® 2: Sterilizing-Grade Filters


Sartopore® 2 0.2 µm Sterilizing-Grade Filter Elements are the industry standard for high-performance liquid sterile filtration. With a unique hydrophilic heterogeneous double-layer design, these filters offer exceptionally high throughput and excellent flow rates, making them ideal for a wide range of applications.


Key Features

  • Hydrophilic Double Layer Design: Features a 0.45 μm pre-filter and a 0.2 μm final filter membrane, ensuring high throughput and flow rate. This design enhances filtration efficiency, reducing processing time and costs.
  • Polyethersulfone Membrane: Provides broad chemical compatibility, including a pH range from 1 to 14, and high thermal resistance. This ensures reliable performance across various chemical environments.
  • Validated Sterilizing Grade: Fully validated according to ASTM F-838 guidelines, each filter element undergoes integrity testing, ensuring absolute reliability and compliance with regulatory standards.
  • Scalability: Available in a wide range of sizes and formats, from 4.5 cm² up to 1.8 m² per filter element, allowing for seamless scale-up from R&D to full-scale production.


Applications

Typical applications include bioburden and particle removal of

  • Therapeutics
  • Biological Fluids
  • Ophthalmic solutions
  • Injectables
  • Media
  • SVPs and LVPs
  • Antibiotics
  • WFI
  • Buffers
  • Chemicals
  • Cleaning and sanitizing agents
  • Bulk pharmaceutical products


Benefits

  • High Throughput: The unique membrane design allows for high flow rates at low pressure drops, optimizing processing efficiency.
  • PFAS restrictions: Made without intentionally using PFAS compounds to ensure you are prepared for potential future restrictions.
  • Broad Compatibility: The Polyethersulfone membrane ensures compatibility with a wide range of chemicals, enhancing versatility in application.
  • Reliability and Compliance: Each filter is integrity tested and meets stringent regulatory standards, providing peace of mind and assurance in critical applications.


Sartopore® 2 filters are designed to meet the demanding needs of the pharmaceutical and biotechnology industries, offering unparalleled performance and reliability.

Applications

  • Application
    High capacity platform for conventional sterile filtration
  • Industry
    Pharma / Biotech
  • Modality
    Buffer & Auxiliaries Filtration
  • Scale
    Product Development | Scale Up Filters

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
    1/4" Multiple Stepped Hose Barb
  • Connector Outlet
    1/4" Multiple Stepped Hose Barb
  • Connector(s)
    Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb

Dimensions

  • Filter Size
    size 4 (0.015 m² / 0.16 ft²)
  • Filtration Area
    0.015 m²
  • Outer Diameter
    63 mm (46 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Capsules
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C
    • 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    1 mL/min at 2.5 bar | 36 psi at 20 °C
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    Standard

Materials of Construction

  • Housing Material
    Polypropylene (PP)
  • Material o-ring | seal
    Silicone (SI)
  • Membrane Material
    Polyethersulfone (PES)
  • Support Fleece
    Polyester (PET)

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 4 bar, 50 °C: 3 bar
  • Maximum Operating Pressure
    4 bar (58 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
    0.2 µm
  • Pore Size Pre-filter
    0.45 µm

Product Information

  • Brand
    Sartopore® 2
  • Pack Size
    5

Sterility/Purity

  • Delivery Condition
    Non sterile - Gamma irradiatable
  • Sterilization Method
    Gamma Irradiatable

Usage Protocols

  • Sterilization Procedures
    Gamma Irradiation: with 50 kGy, 1 Cycle