Sartorius, 5441307G4G-SS--B, Sartopore® 2 XLG | Gamma Capsule | 0.2µm | Size 4 | 5pc

Effective Filtration Area: 0.021 m² | 0.22 ft²
Pore Size: 0.8 µm prefilter | 0.2 µm final filter
Connectors: Inlet: Sanitary ¾“|Outlet: Sanitary ¾“
Sterilization: Gamma sterializable
Membrane Material: Polyethersulfone
Pack Size: 5 pieces
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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 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 XLG Gamma filters ideally suited for the filtration of high and low pH solutions in pharmaceutical | Biotech Industry
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 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.

Specifications
Applications:
Application: High capacity platform for conventional sterile filtration
Industry: Pharma / Biotech
Modality: Media Filtration; Buffer & Auxiliaries Filtration; Downstream Intermediates; Filtration after Virus Inactivation; Form & Fill
Scale: Product Development | Scale Up Filters

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: 3/4" Tri-clamp 25 mm
Connector Outlet: 3/4" Tri-clamp 25 mm
Connector(s): Inlet: ¾" Sanitary | Outlet: ¾" Sanitary

Dimensions:
Filter Size: size 4 (0.021 m² / 0.22 ft²)
Outer Diameter: 63 mm (46 mm without Connection / Valves)

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
Maximum Diffusion: 1.1 mL/min at 2.5 bar | 36 psi at 20 °C
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: 4 bar, 50 °C: 2 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: 0.8 µm

Product Information:
Brand: Sartopore® 2 XLG
Pack Size: 5

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

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