Sartorius, 5445306G9--FF--A, Sartopore® 2 | Midicaps® | 0.45µm | Size 9 | 4pc.

Effective Filtration Area: 0.1 m² | 1.1 ft²
Pore Size: 0.8 µm prefilter | 0.45 µm final filter
Connectors: Inlet: Sanitary ¾“ | Outlet: Sanitary ¾“
Sterilization: Delivered sterile (Autoclaved)
Membrane Material: Polyethersulfone
Pack Size: 4 pieces
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Extremely high flow rates and total throughputs
Number one choice for bioburden reduction & particle removal
Broad compatibility and easy scalability
Outstanding filtration performance of aqueoussolutions that are highly viscous & difficult to filter
Main Applications
Typical applications include bioburden and particle removal of:
Therapeutica
Injection solutions
Buffer
Biological Fluids
Tissue culture media
Acidic and alkaline solutions
Membrane
Sartopore® 2 uses a heterogeneous double membrane made of polyethersulfone
Compatibility
Sartopore®2 filters have been developed for sterilization using autoclaving at 134°C | 2bar. The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 filters ideal for filtering solutions with a high/low pH.
Cost savings:
By using single-use filter elements, there is no need to invest in stainless steel filter housings. Additional costs for cleaning the housing and cleaning validation are eliminated.
Flexibility
Sartopore® 2 filters are available in different sizes and formats with corresponding filter areas from 4.5 cm² up to 1.8 m². Different connections allow easy integration into existing systems.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be performed safely because all Sartopore® filter elements are manufactured with the same membrane type and construction materials.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Microbial Retention
Sartopore® 2 filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.
Documentation:
Sartopore® 2 filters have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements.

Specifications
Applications:
Application: High capacity platform for conventional sterile filtration
Industry: Pharma / Biotech
Modality: Downstream Intermediates; Harvest | Cell Removal
Scale: Production | Small Scale

Compliance Information:
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
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".

Connections (Physical):
Connector Inlet: 3/4" Tri-clamp 25 mm
Connector Outlet: 3/4" Tri-clamp 25 mm
Connector(s): Inlet: ¾" Sanitary | Outlet: ¾" Sanitary

Dimensions:
Filter Size: size 9 (0.2 m² / 2.2 ft²)
Filtration Area: 0.2 m²
Outer Diameter: 108.5 mm (77 mm without Connection / Valves)

General Specifications:
Capsule/Cartridge Format: Midicaps®
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Maximum Diffusion: at 20 °C: 0.05 m² | 0.5 ft²: 3 mL/min at 1.7 bar | 25 psi; 0.1 m² | 1 ft²: 4 mL/min at 1.7 bar | 25 psi; 0.2 m² | 2 ft²: 6 mL/min at 1.7 bar | 25 psi; 0.45 m² | 5 ft²: 12 mL/min at 1.7 bar | 25 psi
Minimum Required Bubble Point: 2.2 bar | 32 psi
Vent Valve: Standard

Materials of Construction:
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone (PES)
Support Fleece: Polypropylene (PP)

Operating Conditions:
Maximum Differential Pressure: 20 °C: 5 bar, 50 °C: 3 bar
Maximum Operating Pressure: 5 bar (72.5 psi)

Physicochemical Information:
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.
Pore Size Final-filter: 0.45 µm
Pore Size Pre-filter: 0.8 µm

Product Information:
Brand: Sartopore® 2
Pack Size: 4

Sterility/Purity:
Delivery Condition: Sterile - Autoclaved
Sterilization Method: Autoclavable

Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles