Sartorius, 5445307H9--SS--A, Sartopore® 2 | Midicaps® | 0.2µm | Size 9 | 4pc.

Effective Filtration Area: 0.2 m² | 2.2 ft² Pore Size: 0.45 µm prefilter | 0.2 µm final filter Connectors: Inlet: Sanitary 1 ½“ | Outlet: Sanitary 1 ½“ Sterilization: Delivered sterile (Autoclaved) Membrane Material: Polyethersulfone Pack Size: 4 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: 1.5" Tri-clamp 50 mm Connector Outlet: 1.5" Tri-clamp 50 mm Connector(s): Inlet: 1 ½" Sanitary | Outlet: 1 ½" 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 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: 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: 0.2 µm Pore Size Pre-filter: 0.45 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