Filter- Loop-Assembly with Sartocube® Self Contained Unit 10 kDa
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<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
- Item No.:
- 4XC41
Choose your Sartocon® Self Contained Filter Loop Assemblies
<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
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IndustryPharma / Biotech
Compliance Information
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Biological ReactivityAll 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).
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ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Dimensions
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Filtration Area3.5 m² | PES
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Flow Channel GeometryProtein conc. <20% /or viscosity max.3cp
General Specifications
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Cassette FormatSartocube Cassettes
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Filter ClassUltrafilter
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Filter FormatCassettes
Materials of Construction
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Integral FramePolypropylene (PP)
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Membrane MaterialPolyethersulfone (PES)
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Sealing CompoundSilicone Grey
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SpacerPolypropylene (PP)
Operating Conditions
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Maximum Inlet Pressure3 bar
Physicochemical Information
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MWCO10 kD
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Non-Fiber ReleasingThis filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
Product Information
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BrandSartocon®