Sartopore® 2 | Gamma Capsule | 0.2µm | Size 4 | 5pc.
- Effective Filtration Area: 0.015 m² | 0.16 ft²
- Pore Size: 0.45 µm prefilter | 0.2 µm final filter
- Connectors: Inlet: Hose Barb ¼“ multiple stepped | Outlet: Hose Barb ¼“ multiple stepped
- Sterilization: Gamma-irradiatable
- Membrane Material: Polyethersulfone
- Pack Size: 5 pieces
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Connector explanation:
O = Hose Barb ¼“ | S = Sanitary ¾“ | N = NPT-male ¼“
- Item No.:
- 5441307H4G-OO--B
- Pieces
- 5
*Custom/bulk order quotes are provided within 72 hours of request.
Choose your Sartopore® 2
- 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 Gamma filters have been developed for sterilization using gamma irradiation < in 50 kGy irradiation doses. The Sartopore® 2 polyethersulfone membrane has a high chemical compatibility between pH 1 to 14, making Sartopore® 2 Gamma filters ideally suited for the filtration of high and low pH solutions in pharmaceutical | Biotech Industry
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.
Applications
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ApplicationHigh capacity platform for conventional sterile filtration
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IndustryPharma / Biotech
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ModalityBuffer & Auxiliaries Filtration
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ScaleProduct Development | Scale Up Filters
Biological Information
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Bacterial RetentionQuantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
Compliance Information
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Bacterial Endotoxins< 0.25 EU/mL as determined by the LAL test
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Biological ReactivityAll 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).
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ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical)
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Connector Inlet1/4" Multiple Stepped Hose Barb
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Connector Outlet1/4" Multiple Stepped Hose Barb
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Connector(s)Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb
Dimensions
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Filter Sizesize 4 (0.015 m² / 0.16 ft²)
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Filtration Area0.015 m²
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Outer Diameter63 mm (46 mm without Connection / Valves)
General Specifications
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Capsule/Cartridge FormatCapsules Size 4&5
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Maximum Allowable Back Pressure
-
2 bar (29 psi) at 20°C
- 1.5 bar (21.8 psi) at 50°C
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2 bar (29 psi) at 20°C
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Maximum Diffusion1 mL/min at 2.5 bar | 36 psi at 20 °C
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Minimum Required Bubble Point3.2 bar | 46 psi
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Vent ValveStandard
Materials of Construction
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Housing MaterialPolypropylene (PP)
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Material o-ring | sealSilicone (SI)
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Membrane MaterialPolyethersulfone (PES)
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Support FleecePolyester (PET)
Operating Conditions
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Maximum Differential Pressure20 °C: 4 bar, 50 °C: 2 bar
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Maximum Operating Pressure4 bar (58 psi)
Physicochemical Information
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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.
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Pore Size Final-filter0.2 µm
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Pore Size Pre-filter0.45 µm
Product Information
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BrandSartopore® 2
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Pack Size5
Sterility/Purity
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Delivery ConditionNon sterile - Gamma irradiatable
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Sterilization MethodGamma Irradiatable
Usage Protocols
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Sterilization ProceduresGamma Irradiation: with 50 kGy, 1 Cycle
The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.
All members of the Sartoguard family utilize a highly asymmetric polyether sulfone (PES) membrane double layer for unmatched protection of final filters and bioburden reduction with an LRV of 6 per cm². In addition, combinations with different depth filter materials and gamma sterilizable versions are available.