Bag Loop with Sartocon® Slice Self Contained Unit PES 30 kDa

Screen Type: E-Screen

Cut-Off: 30 kDa

Membrane Material: Polyethersulfone

System:SARTOFLOW® Alpha plus SU

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

  • Self-Contained filter unit
  • 10L recirculation bag (including a thermowell and a vent filter)
  • Tubing and peristaltic pump tubing
  • 4 pressure domes
  • Retentate and permeate flow meters

Item No.: 
SFA-SU-1465901

*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

  • Channel Height
    E-screen  
  • Filtration Area
    0.14 m²  
  • Flow Channel Geometry
    Protein conc. >20% /or viscosity above.3cp  

General Specifications

  • Cassette Format
    • Slice Cassettes  
    • Sartocon® SCU  
  • Filter Class
    Ultrafilter  
  • Filter Configuration
    Slice Cassette  
  • Filter Format
    Cassettes  

Materials of Construction

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

Operating Conditions

  • Maximum Inlet Pressure
    3 bar  

Physicochemical Information

  • MWCO
    30 kDa  
  • 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®