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

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

Screen Type: ECO

Cut-Off: 10 kDa

System: FlexAct® UD

Gamma sterilized and ready to use filter loop assembly that includes:

  • 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.

Description

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.

Application

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.

Features and Benefits

Totally enclosed process with integrated loop assembly

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

Color coding

-Eliminating installation errors

Pre-flushed and sterile

-Ready to use

Single-use

- 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

Low protein binding membrane

- High product yield and high sustained flux

No use of glues

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®