Sartopore® 2 XLI | Gamma Maxicaps® | 0.2µm | 10"

Tailored for large-scale production, Sartopore® 2 XLI Maxicaps® offer superior filtration capacity and flow performance, ensuring reliable and efficient processing of large volume parenterals.

Filter Size
Type
Connector(s)
Price (USD)
$1,180.00
Item No.: 
5447307I1G-OO
Piece
1
*Custom/bulk order quotes are provided within 72 hours of request.
Sartopore® 2 XLI | Gamma Maxicaps® | 0.2µm | 10"
Sartopore® 2 XLI | Gamma Maxicaps® | 0.2µm | 10

Tailored for large-scale production, Sartopore® 2 XLI Maxicaps® offer superior filtration capacity and flow performance, ensuring reliable and efficient processing of large volume parenterals.

Price (USD):
$1,180.00
Item No.:
5447307I1G-OO
Number of pieces
1

Overview

Specifications

Sartopore® 2 XLI Sterilizing-Grade Filter Elements: Superior Filtration for Chemically Defined Process Fluids

Sartopore® 2 XLI filters are designed to deliver exceptional filtration performance with a low filter consumption. These sterilizing-grade filter elements are ideal for both conventional and single-use processes in downstream processing of chemically defined process fluids. With outstanding capacity and flow performance, Sartopore® 2 XLI filters ensure high process efficiency, minimized filtration costs, and short filtration cycle times.

Key Features

  • Advanced Membrane Design: Featuring a 0.35 μm pre-filter paired with a 0.2 μm final filter, Sartopore® 2 XLI filters deliver exceptional throughput and flow rate performance. This design enhances process efficiency and contributes to reduced filtration costs.
  • The XL family: The XL in its name indicates an increased effective filtration area. Thanks to a different pleating technology, these filters offer a 30-40% larger EFA compared to conventional Sartopore® 2 filters, depending on the format. This enhancement results in greater total throughput per filter element, reducing filter consumption and allowing for smaller filter elements, thereby minimizing both footprint and waste.
  • Scalability: Available in a broad range of sizes and formats, Sartopore® 2 XLI filters offer linear scale-up from R&D to commercial process scale in the range of 4.5 cm² up to 2.4 m². This flexibility allows customers to select the filter that best suits their cost and capacity needs.
  • Regulatory Compliance: Each filter element is fully validated as a sterilizing-grade filter according to ASTM current F-838 guidelines, ensuring compliance with regulatory requirements and providing peace of mind to customers.
  • Durable Materials: Constructed with polyethersulfone membranes and polypropylene components, these filters are designed for durability and reliability, supporting multiple sterilization cycles.

Applications

  • Ophthalmic Solutions
  • Chemically Defined Cell Culture Media
  • High Viscous Large Volume Parenterals
  • Any Fully Chemically Defined Media


Benefits

  • Outstanding Capacity and Flow Performance: The enlarged filtration area and dual-layer membrane design result in high throughput and efficient filtration, reducing cycle times and operational costs.
  • Economic Sizing for Intermediate Steps: The scalability and range of sizes available allow for cost-effective filtration solutions tailored to specific process requirements.
  • PFAS restrictions: Made without intentionally using PFAS compounds to ensure you are prepared for potential future restrictions.
  • High Process Efficiency: The combination of advanced filtration technology and durable materials ensures reliable performance, minimizing downtime and maximizing productivity.
  • Compliance and Safety: Fully validated and compliant with industry standards, Sartopore® 2 XLI filters provide assurance of product safety and quality.

Sartopore® 2 XLI filters are the optimal choice for efficient and reliable filtration of chemically defined process fluids. With their advanced design, scalability, and compliance with industry standards, these filters provide significant benefits in terms of process efficiency, cost savings, and product safety. Whether for ophthalmic solutions, cell culture media, or large volume parenterals, Sartopore® 2 XLI filters deliver superior performance and value.

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".

Connections (Physical)

  • Connector Inlet
    1/2" Single Stepped Hose Barb
  • Connector Outlet
    1/2" Single Stepped Hose Barb
  • Connector(s)
    Inlet: ½" Hose Barb | Outlet: ½" Hose Barb

Dimensions

  • Filter Size
    10"(0.8 m² / 8.6 ft²)
  • Outer Diameter
    137 mm (110 mm without Connection / Valves)

General 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
  • Maximum Diffusion
    21 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: 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
    0.2 µm
  • Pore Size Pre-filter
    0.35 µm

Product Information

  • Brand
    Sartopore® 2 XLI
  • Pack Size
    1
  • Type
    Inline (γ-irradiatable)

Sterility/Purity

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

Usage Protocols

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