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
- Item No.:
*Custom/bulk order quotes are provided within 72 hours of request.
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.
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
-Eliminating installation errors
Pre-flushed and sterile
-Ready to 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
IndustryPharma / Biotech
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).
ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Filtration Area3.5 m² | Hydrosart®
Flow Channel GeometryProtein conc. <20% /or viscosity max.3cp
Cassette FormatSartocube Cassettes
Materials of Construction
Integral FramePolypropylene (PP)
Sealing CompoundSilicone Grey
Maximum Inlet Pressure3 bar
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.