Sartoguard PES | T-Style Maxicaps® | 0.2µm | 10"

  • Effective Filtration Area: 0.8 m² | 8.6 ft²
  • Pore Size: 1.2 µm prefilter | 0.2 µm final filter
  • Membrane Material: Polyethersulfone
  • Connectors: Inlet: Hose Barb ½“ single stepped | Outlet: Hose Barb ½“ single stepped
  • Sterilization: Hybrid: Gamma-irradiatable | Autoclavable

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Connector explanation:

O = Hose Barb ½“ | S = Sanitary 1 ½“

Size explanation:

10” = 0.8 m² | 20” = 1.6 m² | 30” = 2.4 m²

Filter Size
Type
Connector(s)
Item No.: 
5478307F1G-OO
Availability: 
Piece
1

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

The asymmetric polyether sulfone (PES) membranes used in Sartoguard PES filters achieve an LRV of 6 per cm². This significantly reduces the bioburden in the downstream process and protects subsequent purification steps. When used upstream of sterilization grade filters, Sartoguard PES increases overall throughput and reduces the number of filters required and process costs.

Main Applications

  • Bioburden reduction in protein- and virus-based therapies as well as in processes producing pDNA/mRNA based therapies
  • Protection of purification equipment and sterilizing-grade filters

Benefits

  • More economical process flow
  • Downsizing of filtration systems
  • Significantly higher total throughput performance
  • LRV of 6 per cm2 filtration area for Brevundimonas Diminuta (0.1 µm version) and for Serratia Marcescens (0.2 µm version)

Membrane

Sartoguard PES uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartoguard PES 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 Sartoguard PES filters ideal for filtering solutions with a high/low pH.

Cost savings:

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

Sartoguard PES filters are available in a wide range of filtration areas from 4.5 cm² up to 1.8 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 safely performed because all Sartoguard PES filter elements are manufactured with the same membrane type, support fleeces and construction materials.

Quality:

Every single element is tested for integrity to meet the highest quality requirements.

Documentation:

Sartoguard PES 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
    • mAB Production
    • Protection of Final Filters
  • Industry
    Pharma / Biotech
  • Modality
    • Media Filtration
    • Harvest | Cell Removal
    • Filtration after Virus Inactivation
  • Scale
    Production | Large Scale

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
    178 mm (110.4 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    T-Style Maxicaps®
  • Filter Format
    Capsules
  • Maximum Diffusion
    18 mL/min at 1.2 bar | 17.5 psi
  • Minimum Required Bubble Point
    1.8 bar | 26 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
    5 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
    1.2 µm

Product Information

  • Brand
    Sartoguard PES
  • Pack Size
    1
  • Type
    T-Style (Autoclavable | γ-irradiatable)

Sterility/Purity

  • Delivery Condition
    Non-Sterile
  • Sterilization Method
    Autoclavable & Gamma Irradiatable

Usage Protocols

  • Sterilization Procedures
    • Autoclaving: at 134°C, 30 min, 2 bar
    • Gamma Irradiation: with 50 kGy