Sartorius, 5441306G5--OO--B, Sartopore® 2 | Capsule | 0.45µm | Size 5 | 5pc.

Effective Filtration Area: 0.03 m² | 0.32 ft²
Pore Size: 0.8 µm prefilter | 0.45 µm final filter
Connectors: Inlet: Hose Barb ¼“ multiple stepped | Outlet: Hose Barb ¼“ multiple stepped
Sterilization: Delivered sterile (autoclaved)
Membrane Material: Polyethersulfone
Pack Size: 5 pieces

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: Harvest | Cell Removal
Scale: Product Development | Scale Up Filters

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: 1/4" Multiple Stepped Hose Barb
Connector Outlet: 1/4" Multiple Stepped Hose Barb
Connector(s): Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb

Dimensions:
Filter Size: size 5 (0.03 m² / 0.32 ft²)
Outer Diameter: 65 mm

General Specifications:
Capsule/Cartridge Format: Capsules Size 4&5
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
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: 4 bar, 50 °C: 2 bar
Maximum Operating Pressure: 4 bar (58 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: 5
Type: Size 5 | Connectors: OO

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

Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles