Sartopore® 2 XLG | Cartridge | 0.2µm | 10"
- Effective Filtration Area: 0.8 m² | 8.6 ft²
- Pore Size: 0.8 µm prefilter | 0.2 µm final filter
- Membrane Material: Polyethersulfone
- Sterilization: In-line steamable | Autoclavable
- Adapter: 2-Flange Bayonet | 226 Double O-ring
- O-ring material: Silicone
- Price (USD):
- $734.00
- Item No.:
- 5442507G1
- Piece
- 1
*Custom/bulk order quotes are provided within 72 hours of request.
Choose your Sartopore® 2
Sartopore® 2 XLG is a high-performance membrane filter, offering more than just reliable sterilizing-grade filtration in biopharmaceutical processes. Its highly asymmetric membrane structure and composition of 0.8µm prefilter in front of the sterilizing-grade filter (0.2 µm pore size), boosts the filtration efficiency in downstream processing of protein-based therapies or innovative drug delivery systems like lipid nanoparticles (LNPs). Thanks to the outstanding total throughput, Sartopore® 2 XLG is also a choice for filtration after the cell harvest.
Main Applications
Focus applications include:
- Cell culture media preparation
- Post cell harvest filtration
- Protein-based therapies (Downstream intermediates, form & fill)
- Lipid nanoparticles (Downstream intermediates, form & fill)
Your Benefits
- Increased total throughput leads to less filter consumption, less process interruptions and reduced costs
- Increased effective filtration enables the use of smaller filters to reduce footprint and waste
- Proven and robust membrane chemistry known from the widely established Sartopore® 2 family lowers validation effort in case of process optimization
- Broad range of formats and sizes assures scalability and enables use of Sartopore® 2 XLG along the whole drug product lifecycle: from development to commercial processes
- Offers secure bacterial retention according to ASTM guidelines
The XL family
The XL in its name indicates an increased effective filtration area (EFA). By using a different pleating technology, the EFAs of Sartopore ® 2 XLG filters are - depending on filter format - 30-40% higher than for the conventional Sartopore® 2 filters. This leads to higher total throughput per filter element and less filter consumption or enables the use of a smaller filter element for a process to reduce the footprint and waste.
Membrane
Sartopore® 2 XLG uses a heterogeneous double membrane made of polyethersulfone
Compatibility
Sartopore®2 XLG Cartridges have been developed for sterilization using either autoclaving or in-line-steaming. The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14.
Flexibility
Sartopore® 2 XLG filters are available in a wide range of filtration areas from 4.5 cm² up to 2.4 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 XLG filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.
Documentation:
Sartopore® 2 XLG 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
-
Modality
-
Media Filtration
-
Buffer & Auxiliaries Filtration
-
Downstream Intermediates
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Filtration after Virus Inactivation
- Form & Fill
-
Media Filtration
Biological Information
-
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)
-
Connector Inlet2-Flange Bayonet Adapter with 226 Double O-ring (25)
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Connector Outlet2-Flange Bayonet Adapter with 226 Double O-ring (25)
Dimensions
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Filter Size10"(0.8 m² / 8.6 ft²)
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Filtration Area0.8 m²
-
Outer Diameter70 mm
General Specifications
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Capsule/Cartridge FormatCartridges
-
Maximum Allowable Back Pressure
-
2 bar (29 psi) at 20°C
- 1 bar (14.5 psi) at 80°C
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2 bar (29 psi) at 20°C
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Maximum Diffusion23 mL/min at 2.5 bar | 36 psi at 20 °C per 10 inch element
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Minimum Required Bubble Point3.2 bar | 46 psi
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 FleecePolypropylene (PP)
Operating Conditions
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Maximum Differential Pressure20 °C: 5 bar, 80 °C: 2 bar
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Maximum Operating Pressure5 bar (72.5 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
-
Pore Size Pre-filter0.8 µm
Product Information
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BrandSartopore® 2 XLG
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Pack Size1
-
TypeCartridge | 10"
Sterility/Purity
-
Delivery ConditionNon sterile - Autoclavable | Steamable
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Sterilization MethodAutoclavable & In-Line Steam Sterilizable
Usage Protocols
-
Sterilization Procedures
-
In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
- Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
-
In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
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.