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- Sartopore® 2 | 0.45 µm | Sartoscale (PD | Material Screening)
Sartopore® 2 Sartoscale 47 0.45µm | 3pc
Ideal for material testing and screening in the PD area, Sartopore® 2 Sartoscales feature a hydrophilic double-layer design for precise filtration. It ensures high throughput and reliability, optimizing process efficiency in diverse testing environments.
- Item No.:
- 5445306GS--FF--M
- Pieces
- 3
Ideal for material testing and screening in the PD area, Sartopore® 2 Sartoscales feature a hydrophilic double-layer design for precise filtration. It ensures high throughput and reliability, optimizing process efficiency in diverse testing environments.
Overview
Specifications
Choose your Sartopore® 2
Sartopore® 2 0.45µm Bioburden & Particle Retentive Filter Elements
Introduction Sartopore® 2 0.45 µm filters are designed to deliver exceptional filtration performance, making them the perfect choice for bioburden reduction and particle removal in pharmaceutical applications. With their unique hydrophilic Polyethersulfone membrane, these filters offer extremely high flow rates and total throughputs, ensuring maximum process efficiency and minimized filtration costs.
Key Features
- Built-in Prefiltration: Equipped with a 0.8 μm membrane for enhanced bioburden reduction and particle removal, especially suitable for highly viscous and challenging pharmaceutical solutions.
- Outstanding Flow Rates: The hydrophilic Polyethersulfone membrane ensures high flow rates and total throughputs, reducing filtration cycle times and costs.
- Broad Chemical Compatibility: Compatible with a wide pH range from 1 to 14 and high thermal resistance, making it suitable for diverse filtration liquids.
- Integrity Tested: Each filter element undergoes rigorous integrity testing, including Diffusion Point and Bubble Point tests, ensuring absolute reliability.
- Scalability: Available in a wide range of sizes and formats, from 4.5 cm² up to 1.8 m² per filter element, allowing for seamless scale-up from R&D to full-scale production.
Applications
Typical applications include bioburden and particle removal of
- Therapeutics
- Buffers
- Injectables
- Ophthalmics
- Large volume parenterals
- Antibiotics
- Biological Fluids
- Tissue Culture Media
- Bulk pharmaceutical products
- Acetic and basic solutions
Benefits
- High Throughput: The unique membrane design allows for high flow rates at low pressure drops, optimizing processing efficiency.
- PFAS restrictions: Made without intentionally using PFAS compounds to ensure you are prepared for potential future restrictions.
- Broad Compatibility: The Polyethersulfone membrane ensures compatibility with a wide range of chemicals, enhancing versatility in application.
- Reliability and Compliance: Each filter is integrity tested and meets stringent regulatory standards, providing peace of mind and assurance in critical applications.
Sartopore® 2 filters are designed to meet the demanding needs of the pharmaceutical and biotechnology industries, offering unparalleled performance and reliability.
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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Downstream Intermediates
- Harvest | Cell Removal
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Downstream Intermediates
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ScaleProduct Development | Material Screening Filters
Compliance Information
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Bacterial Endotoxins< 0.18 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 Inlet3/4" Sanitary
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Connector Outlet3/4" Sanitary
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Connector(s)Inlet: ¾" Sanitary | Outlet: ¾" Sanitary
Dimensions
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Filter Size17.3 cm²
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Filtration Area17.3 cm²
General Specifications
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Capsule/Cartridge FormatSartoscale 47
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Minimum Required Bubble Point2.2 bar | 32 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)
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-filter0.45 µm
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Pore Size Pre-filter0.8 µm
Product Information
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BrandSartopore® 2
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Pack Size3
Sterility/Purity
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Delivery ConditionNon sterile - Autoclavable
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Sterilization MethodAutoclavable
Usage Protocols
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Sterilization ProceduresAutoclaving: 1 cycle at max. 134 °C, 2 bar | 29 psi, 30 min.