Sartorius, 5445307H0G-OO--V, Sartopore® 2 | Gamma Midicaps® | 0.2µm | Size 0 | 2pc.

Effective Filtration Area: 0.45 m² | 4.8 ft²
Pore Size: 0.45 µm prefilter | 0.2 µm final filter
Connectors: Inlet: Hose Barb ½“ single stepped | Outlet: Hose Barb ½“ single stepped
>Sterilization: Gamma-irradiatable
Membrane Material: Polyethersulfone
Pack Size: 2 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.
Performance
A unique pleated filter construction combined with the highly asymmetrical pore structure of the membrane enables excellent flow rates and lifetimes, particularly compared to conventional flat filter systems. By means of "integrated prefiltration" in the form of a 0.45 μm membrane, the Sartopore 2 filters achieve outstanding total flow and excellent flow rates.
Cost savings:
The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.
Flexibility
Sartopore® 2 filters are available in a wide range of filtration areas from 4.5 cm² up to 1.8 m² and with a variety of commonly used connections to ensure easy integration into your process regardless of batch size.
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: Buffer & Auxiliaries Filtration
Scale: Production | Small Scale

Biological Information:
Bacterial Retention: Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

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: 1/2" Single Stepped Hose Barb
Connector Outlet: 1/2" Single Stepped Hose Barb
Connector(s): Inlet: ½" Hose Barb | Outlet: ½" Hose Barb

Dimensions:
Filter Size: size 0 (0.45 m² / 4.8 ft²)
Filtration Area: 0.45 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 and 2.5 bar | 36 psi: 0.05 m² | 0.5 ft²: 4 mL/min ; 0.1 m² | 1 ft²: 5 mL/min; 0.2 m²| 2 ft²: 7 mL/min; 0.45 m² | 4.5 ft²: 14 mL/min
Minimum Required Bubble Point: 3.2 bar | 46 psi
Vent Valve: Standard

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

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: 0.2 µm
Pore Size Pre-filter: 0.45 µm

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

Sterility/Purity:
Delivery Condition: Non sterile - Gamma irradiatable
Sterilization Method: Gamma Irradiatable

Usage Protocols:
Sterilization Procedures: Gamma Irradiation: with 50 kGy, 1 Cycle