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- Sterile Filtration & Mycoplasma Removal & Bioburden Control
- Sartopore® 2 | 0.2 µm | Cartridge (Production | Small to Large Scale)
Sartopore® 2 | Mini Cartridge | 0.2µm | Size 8 | 5pc.
Sartopore® 2 Cartridges cater to small to large-scale production needs, providing versatile filtration solutions with high throughput. Their durable design and broad compatibility ensure consistent and reliable results.
- Price (USD)
- $900.00
- Item No.:
- 5441507H8------B
- Pieces
- 5
Sartopore® 2 Cartridges cater to small to large-scale production needs, providing versatile filtration solutions with high throughput. Their durable design and broad compatibility ensure consistent and reliable results.
Overview
Specifications
Choose your Sartopore® 2
Sartopore® 2: Sterilizing-Grade Filters
Sartopore® 2 0.2 µm Sterilizing-Grade Filter Elements are the industry standard for high-performance liquid sterile filtration. With a unique hydrophilic heterogeneous double-layer design, these filters offer exceptionally high throughput and excellent flow rates, making them ideal for a wide range of applications.
Key Features
- Hydrophilic Double Layer Design: Features a 0.45 μm pre-filter and a 0.2 μm final filter membrane, ensuring high throughput and flow rate. This design enhances filtration efficiency, reducing processing time and costs.
- Polyethersulfone Membrane: Provides broad chemical compatibility, including a pH range from 1 to 14, and high thermal resistance. This ensures reliable performance across various chemical environments.
- Validated Sterilizing Grade: Fully validated according to ASTM F-838 guidelines, each filter element undergoes integrity testing, ensuring absolute reliability and compliance with regulatory standards.
- 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
- Biological Fluids
- Ophthalmic solutions
- Injectables
- Media
- SVPs and LVPs
- Antibiotics
- WFI
- Buffers
- Chemicals
- Cleaning and sanitizing agents
- Bulk pharmaceutical products
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.
Accessories Information
-
AdapterBottom: Bayonet w. o-ring | Top: Flat
Applications
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ApplicationHigh capacity platform for conventional sterile filtration
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IndustryPharma / Biotech
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ModalityBuffer & Auxiliaries Filtration
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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
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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".
Dimensions
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Filter Sizesize 8 (0.1 m² / 1.08 ft²)
-
Filtration Area0.1 m²
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Outer Diameter56 mm
General Specifications
-
Capsule/Cartridge FormatMini Cartridges
-
Maximum Allowable Back Pressure
-
2 bar (29 psi) at 20°C
- 1 bar (14.5 psi) at 80°C
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2 bar (29 psi) at 20°C
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Maximum Diffusion5 mL/min at 2.5 bar | 36 psi at 20 °C
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Minimum Required Bubble Point3.2 bar | 46 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)
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Support FleecePolypropylene (PP)
Operating Conditions
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Maximum Differential Pressure20 °C: 5 bar, 80 °C: 2 bar
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
-
Pore Size Pre-filter0.45 µm
Product Information
-
BrandSartopore® 2
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Pack Size5
Sterility/Purity
-
Delivery ConditionNon sterile - Autoclavable | Steamable
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Sterilization MethodAutoclavable & In-Line Steam Sterilizable
Usage Protocols
-
Sterilization Procedures
-
In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
- Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
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In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles