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  • Filter- Loop-Assembly with Sartocube® Self Contained Unit 10 kDa

Filter- Loop-Assembly with Sartocube® Self Contained Unit 10 kDa

<b>Screen Type:</b> ECO

<b>Cut-Off: </b> 10 kDa

<b>System: </b> FlexAct® UD

<b>Gamma sterilized and ready to use filter loop assembly that includes</b>:

  • Self-Contained filter unit
  • Tubing with Opta® connectors
  • 2 pressure domes
  • TMP control pinch valve
  • Disposable pump head

Filtration Area
Item No.: 
4XC41
Availability: 
*Custom/bulk order quotes are provided within 72 hours of request.

<h3>Description</h3>

Bag loop assemblies for the SARTOFLOW® Alpha plus SU are supplied sterile and ready to use.

All product wetted parts of the system are supplied sterile and made from single-use components.

The cassette is designed with the same hydrodynamic flow path as our larger production scale filter cassettes, enabling linear scale-up to larger filter areas.

The single-use concept is an ideal choice for contract manufacturers, research and development applications and all companies with multiproduct through-put.

<h3>Application</h3>

The system is suitable for use in cGMP environments for process development, clinical trials and for small-scale production batches.

Due to the fully enclosed design the assembly is well suited for vaccine, recombinant protein, and highly toxic ADC production.

<h3>Features and Benefits</h3>

<b>Totally enclosed process with integrated loop assembly</b>

-Fully disposable results in operator safety due to no product contact

<b>Color coding</b>

-Eliminating installation errors

<b>Pre-flushed and sterile</b>

-Ready to use

<b>Single-use</b>

- No CIP with associated water flush and validation required

- No cleaning validation , CFW determination and storage preparation, leads to cost and time saving in set up and validation effort

<b>Low protein binding membrane</b>

- High product yield and high sustained flux

<b>No use of glues</b>

Low extractables

Applications

  • Industry
    Pharma / Biotech

Compliance Information

  • 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

  • Filtration Area
    3.5 m² | PES
  • Flow Channel Geometry
    Protein conc. <20% /or viscosity max.3cp

General Specifications

  • Cassette Format
    Sartocube Cassettes
  • Filter Class
    Ultrafilter
  • Filter Format
    Cassettes

Materials of Construction

  • Integral Frame
    Polypropylene (PP)
  • Membrane Material
    Polyethersulfone (PES)
  • Sealing Compound
    Silicone Grey
  • Spacer
    Polypropylene (PP)

Operating Conditions

  • Maximum Inlet Pressure
    3 bar

Physicochemical Information

  • MWCO
    10 kD
  • 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.

Product Information

  • Brand
    Sartocon®
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