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- Sartopore® 2 XLI | 0.2 µm | Maxicaps® (Production | Large Scale)
Sartopore® 2 XLI | Gamma Maxicaps® | 0.2µm | 10"
Tailored for large-scale production, Sartopore® 2 XLI Maxicaps® offer superior filtration capacity and flow performance, ensuring reliable and efficient processing of large volume parenterals.
- Price (USD)
- $1,180.00
- Item No.:
- 5447307I1G-OO
- Piece
- 1
Tailored for large-scale production, Sartopore® 2 XLI Maxicaps® offer superior filtration capacity and flow performance, ensuring reliable and efficient processing of large volume parenterals.
Overview
Specifications
Choose your Sartopore® 2
Sartopore® 2 XLI Sterilizing-Grade Filter Elements: Superior Filtration for Chemically Defined Process Fluids
Sartopore® 2 XLI filters are designed to deliver exceptional filtration performance with a low filter consumption. These sterilizing-grade filter elements are ideal for both conventional and single-use processes in downstream processing of chemically defined process fluids. With outstanding capacity and flow performance, Sartopore® 2 XLI filters ensure high process efficiency, minimized filtration costs, and short filtration cycle times.
Key Features
- Advanced Membrane Design: Featuring a 0.35 μm pre-filter paired with a 0.2 μm final filter, Sartopore® 2 XLI filters deliver exceptional throughput and flow rate performance. This design enhances process efficiency and contributes to reduced filtration costs.
- The XL family: The XL in its name indicates an increased effective filtration area. Thanks to a different pleating technology, these filters offer a 30-40% larger EFA compared to conventional Sartopore® 2 filters, depending on the format. This enhancement results in greater total throughput per filter element, reducing filter consumption and allowing for smaller filter elements, thereby minimizing both footprint and waste.
- Scalability: Available in a broad range of sizes and formats, Sartopore® 2 XLI filters offer linear scale-up from R&D to commercial process scale in the range of 4.5 cm² up to 2.4 m². This flexibility allows customers to select the filter that best suits their cost and capacity needs.
- Regulatory Compliance: Each filter element is fully validated as a sterilizing-grade filter according to ASTM current F-838 guidelines, ensuring compliance with regulatory requirements and providing peace of mind to customers.
- Durable Materials: Constructed with polyethersulfone membranes and polypropylene components, these filters are designed for durability and reliability, supporting multiple sterilization cycles.
Applications
- Ophthalmic Solutions
- Chemically Defined Cell Culture Media
- High Viscous Large Volume Parenterals
- Any Fully Chemically Defined Media
Benefits
- Outstanding Capacity and Flow Performance: The enlarged filtration area and dual-layer membrane design result in high throughput and efficient filtration, reducing cycle times and operational costs.
- Economic Sizing for Intermediate Steps: The scalability and range of sizes available allow for cost-effective filtration solutions tailored to specific process requirements.
- PFAS restrictions: Made without intentionally using PFAS compounds to ensure you are prepared for potential future restrictions.
- High Process Efficiency: The combination of advanced filtration technology and durable materials ensures reliable performance, minimizing downtime and maximizing productivity.
- Compliance and Safety: Fully validated and compliant with industry standards, Sartopore® 2 XLI filters provide assurance of product safety and quality.
Sartopore® 2 XLI filters are the optimal choice for efficient and reliable filtration of chemically defined process fluids. With their advanced design, scalability, and compliance with industry standards, these filters provide significant benefits in terms of process efficiency, cost savings, and product safety. Whether for ophthalmic solutions, cell culture media, or large volume parenterals, Sartopore® 2 XLI filters deliver superior performance and value.
Applications
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ApplicationHigh capacity platform for conventional sterile filtration
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IndustryPharma / Biotech
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Modality
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Media Filtration
- Buffer & Auxiliaries Filtration
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Media Filtration
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ScaleProduction | Large Scale
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 Inlet1/2" Single Stepped Hose Barb
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Connector Outlet1/2" Single Stepped Hose Barb
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Connector(s)Inlet: ½" Hose Barb | Outlet: ½" Hose Barb
Dimensions
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Filter Size10"(0.8 m² / 8.6 ft²)
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Outer Diameter137 mm (110 mm without Connection / Valves)
General Specifications
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Capsule/Cartridge FormatMaxicaps®
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Maximum Allowable Back Pressure
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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 Diffusion21 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: 5 bar, 50 °C: 3 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
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Pore Size Pre-filter0.35 µm
Product Information
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BrandSartopore® 2 XLI
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Pack Size1
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TypeInline (γ-irradiatable)
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