Sartoguard PES | Gamma Capsule | 0.1µm | Size 4 | 5pc.

Tech Support Documents
 

Designed for scale-up in the PD area, these capsules provide consistent bioburden reduction and high throughput. The PES membrane ensures robust process control, making them suitable for transitioning from development to production.

Sterilization Method
Connector(s)
Item No.: 
5471358G4G-OO--B
Pieces
5
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Sartoguard PES | Gamma Capsule | 0.1µm | Size 4 | 5pc.
Sartoguard PES | Gamma Capsule | 0.1µm | Size 4 | 5pc.

Designed for scale-up in the PD area, these capsules provide consistent bioburden reduction and high throughput. The PES membrane ensures robust process control, making them suitable for transitioning from development to production.

Item No.:
5471358G4G-OO--B
Number of pieces
5

Overview

Specifications

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Sartoguard PES Prefilters

Sartoguard PES filters support bioburden reduction and membrane prefiltration for cell culture media and clarified harvests. High throughput and strong clarification help shorten cycles while protecting final sterilizing filters and downstream equipment.

Key Features

  • Dual-Layer PES Membrane: Their two membrane layer design pairs clarification with bioburden retention, supporting stable flow and efficient prefiltration.
  • High Throughput and Clarification: Sartoguard PES delivers excellent clarification of process fluids, helping reduce filter count and time per batch.
  • Integrity Testable: On-site diffusion and bubble point testing support reliable qualification and routine release in development and production.
  • Proven Bacteria Retention: Typical LRV 6 per cm² for Serratia marcescens (0.2 µm nominal) provides robust bioburden reduction for process fluids.
  • Scalable Portfolio: Membrane areas from 4.5 cm² to 2.4 m² per element enable linear scale-up and economic sizing from PD to process scale.

Applications

  • Cell Culture Media
  • Downstream Intermediates
  • Clarified cell culture harvest
  • Buffers
  • Aseptically filled Small Volume Parenteral
  • Protection of final filters (before and after UF | DF and chromatography steps)

Benefits

  • Efficient Bioburden Control: Retention performance and clarification help reduce microbial load and particulates, supporting consistent upstream and intermediate steps.
  • Protection of Final Filters: Prefiltration reduces fouling of sterilizing-grade membranes, extending service life and helping to stabilize flow.
  • Shorter Filtration Cycles: High throughput and economic sizing options support reduced processing time and streamlined operations.
  • PFAS: Made without intentionally using PFAS compounds.
  • Reliable Process Verification: Integrity testing by diffusion and bubble point supports reproducible qualification and confident release decisions.
  • Seamless Scale-Up: Common materials and a wide area range simplify transitions from development to commercial scale and help standardize validation.

Applications

  • Application
    • mAB Production
    • Protection of Final Filters
  • Industry
    Pharma / Biotech
  • Modality
    • Media Filtration
    • Buffer & Auxiliaries Filtration
    • Downstream Intermediates
    • Form & Fill
  • Scale
    Product Development | Scale Up Filters

Compliance Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • 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 (0.021 m² / 0.22 ft²)

General Specifications

  • Capsule/Cartridge Format
    Capsules
  • Maximum Diffusion
    1.1 mL/min at 1.5 bar | 22 psi
  • Minimum Required Bubble Point
    2.8 bar | 40.5 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, 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
    0.8 µm

Product Information

  • Brand
    Sartoguard PES
  • Pack Size
    5

Sterility/Purity

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

Usage Protocols

  • Sterilization Procedures
    Gamma Irradiation: with 50 kGy