The gamma sterilized loop assembly consists of a Polyethersulfone membrane (PESU) self contained filter unit, two pressure domes, a TMP control pinch valve, a disposable pump head and tubing with Opta® connectors. Feed and permeate lines are color coded.
Filter Loop assemblies for the FlexAct® UD system are supplied sterile and ready to use. Due to the fully enclosed design the assembly is well suited for vaccine, recombinant protein and highly toxic ADC production. All product wetted parts of the system are supplied sterile and made from single use components. The system is suitable for use in cGMP environments for process development, clinical trials and for small-scale production batches. The cassette is designed with the same hydrodynamic flow path as our Sartocon® Slice Self Contained device, enabling linear scale-up from smaller filter areas. The single use concept is an ideal choice for Contract Manufacturers, research and development applications and all companies with multiproduct through-put.
Polyethersulfone membrane (PESU) ultrafiltration Filter Loop Assemblies are available in the following nominal molecular weight cut-offs: 10 kD, 30 kD, 100 kD and 300 kD.
Sartorius Stedim Biotech Sartocon® Loop Assemblies are availabe in 2 or 5 stack format.
Sainless Steel hydraulic holder available.
Filter area 1.4 m² and 3.5 m²
BiosafetyAll materials of this filter element meet the requirements of the current USP Biological Reactivity tests 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 Area1.4 m²
Flow Channel GeometryProtein conc. <20% /or viscosity max.3cp
Materials of Construction
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.
Filter TypeCrossflow Filters