Product Description
Effective Filtration Area: 0.8 m² | 8.6 ft²
Pore Size: 0.8 µm prefilter | 0.2 µm final filter
Membrane Material: Polyethersulfone
Connectors: Inlet: Sanitary 1 ½“| Outlet: Hose Barb ½“ single stepped
Sterilization: Autoclavable
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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 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.
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: Production | Large Scale
Compliance Information:
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
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" Sanitary
Connector Outlet: 1/2" Single Stepped Hose Barb
Connector(s): Inlet: 1 ½" Sanitary | Outlet: ½" Hose Barb
Dimensions:
Filter Size: 10"(0.8 m² / 8.6 ft²)
General Specifications:
Capsule/Cartridge Format: Maxicaps®
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: 0.8 µm
Product Information:
Brand: Sartopore® 2 XLG
Pack Size: 1
Type: Inline (Autoclavable)
Sterility/Purity:
Delivery Condition: Non sterile - Autoclavable
Sterilization Method: Autoclavable
Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
Order Guidelines
1. Price & Stock Available on Request. Click to send email to: service@iright.com
2. Please DO NOT make payment before confirmtaion.
3. Minimum order value of $1,000 USD required.
4. 100% prepayment required.
Collaboration
Tony Tang
Email: Tony.Tang@iright.com
Mobile/WhatsApp/Wechat: +86-17717886924