Sartopore® 2 XLG | Gamma Midicaps® | 0.2µm | Size 7 | 4pc.
- Effective Filtration Area: 0.065 m² | 0.7 ft²
- Pore Size: 0.8 µm prefilter | 0.2 µm final filter
- Connectors: Inlet: Sanitary 1 ½“| Outlet: Hose Barb ½“ single stepped
- Sterilization: Gamma sterializable
- Membrane Material: Polyethersulfone
- Pack Size: 4 pieces
________________________________________
Connector explanation:
O = Hose Barb ½“ | S = Sanitary 1 ½“ | H = Hose Barb ¼“ | F = Sanitary ¾“
Size explanation:
Size 7 = 0.065 m² | Size 8 = 0.13 m² | Size 9 = 0.26 m² | Size 0 = 0.52 m²
- Item No.:
- 5445307G7G-SO--A
- Pieces
- 4
*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 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.
Applications
-
ApplicationHigh capacity platform for conventional sterile filtration
-
IndustryPharma / Biotech
-
Modality
-
Media Filtration
-
Buffer & Auxiliaries Filtration
-
Downstream Intermediates
-
Filtration after Virus Inactivation
- Form & Fill
-
Media Filtration
-
ScaleProduction | Small Scale
Biological Information
-
Bacterial RetentionQuantitative 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 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).
-
ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical)
-
Connector Inlet1.5" Tri-clamp 50 mm
-
Connector Outlet1/2" Single Stepped Hose Barb
-
Connector(s)Inlet: 1 ½" Sanitary | Outlet: ½" Hose Barb
Dimensions
-
Filter Sizesize 7 (0.065 m² / 0.7 ft²)
-
Outer Diameter108.5 mm (77 mm without Connection / Valves)
General Specifications
-
Capsule/Cartridge FormatMidicaps®
-
Maximum Allowable Back Pressure
-
2 bar (29 psi) at 20°C
- 1.5 bar (21.8 psi) at 50°C
-
2 bar (29 psi) at 20°C
-
Maximum Diffusionat 20 °C and 2.5 bar | 36 psi: 0.065 m² | 0.7 ft²: 5 mL/min; 0.13m² | 1.4 ft²: 6 mL/min; 0.26 m² | 2.8 ft²: 9 mL/min; 0.52 m² | 5.6 ft²: 18 mL/min
-
Minimum Required Bubble Point3.2 bar | 46 psi
-
Vent ValveStandard
Materials of Construction
-
Housing MaterialPolypropylene (PP)
-
Material o-ring | sealSilicone (SI)
-
Membrane MaterialPolyethersulfone (PES)
-
Support FleecePolyester (PET)
Operating Conditions
-
Maximum Differential Pressure20 °C: 5 bar, 50 °C: 3 bar
-
Maximum Operating Pressure5 bar (72.5 psi)
Physicochemical Information
-
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.
-
Pore Size Final-filter0.2 µm
-
Pore Size Pre-filter0.8 µm
Product Information
-
BrandSartopore® 2 XLG
-
Pack Size4
-
TypeSize 7 | Connectors: SO
Sterility/Purity
-
Delivery ConditionNon sterile - Gamma irradiatable
-
Sterilization MethodGamma Irradiatable
Usage Protocols
-
Sterilization ProceduresGamma Irradiation: with 50 kGy, 1 Cycle
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.