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- Sartobran® P | 0.45 µm | Cartridge (Production | Small to Large Scale)
Sartobran® P | Cartridge | 0.45µm | 10" | Adapter 21
Suitable for small to large-scale production, these cartridges feature low-adsorption cellulose acetate membranes for high recovery rates. They offer robust bioburden reduction and are compatible with in-line steam or autoclave sterilization.
- Item No.:
- 5232106D1----P
- Piece
- 1
Suitable for small to large-scale production, these cartridges feature low-adsorption cellulose acetate membranes for high recovery rates. They offer robust bioburden reduction and are compatible with in-line steam or autoclave sterilization.
Overview
Specifications
Choose your Sartobran® P
Sartobran P 0.45 µm for Bioburden Reduction
Sartobran® P 0.45 µm filters provide bioburden and defined particle reduction for biopharmaceutical solutions, especially in vaccine and blood and plasma processes. The cellulose acetate membrane enables very low unspecific adsorption to support high product recovery and efficient processing.
Key Features
- Cellulose Acetate Membrane: Very low unspecific adsorption supports high recovery of proteins and excipients, helping protect product yield.
- Bioburden and Particle Reduction: Applied upstream to protect sterilizing-grade membrane filters and downstream equipment, improving process robustness.
- Linear Scale-Up: Filtration areas from 4.5 cm² to 1.8 m² across different formats enable straightforward scaling from PD to production.
- pH Compatibility: Operates within pH 4–8, covering a large portion of bioprocess fluids used in typical formulations.
- Integrity and Compliance: Each element is integrity tested by bubble point and diffusion methods and manufactured under an ISO 9001 certified Quality Management System.
- Sterilization Flexibility: Autoclavable and in-line steam sterilizable options (by format), with gamma-irradiatable variants available, support integration into existing SOPs.
Applications
- Coagulation Factors, Albumin, IgG
- Bacterial and Viral Vaccines
- Bioprocessed pharmaceuticals
- Intermediate and purified protein solutions
- Biological fluids
- Fluids containing preservatives
Benefits
- High Product Recovery: Very low unspecific adsorption limits product binding and supports high yield in vaccine, plasma, and protein processes.
- Efficient Processing: High throughput and reliable flow performance help shorten filtration cycles and streamline operations.
- Downstream Protection: Upstream bioburden reduction helps protect sterilizing-grade filters and equipment, supporting consistent performance.
- PFAS: Made without intentionally using PFAS compounds.
Accessories Information
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AdapterBottom: Open flat gasket | Top: Open flat gasket
Applications
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Application
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Blood and Plasma
- Vaccine Production
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Blood and Plasma
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IndustryPharma / Biotech
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Modality
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Harvest | Cell Removal
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Downstream Intermediates
- Form & Fill
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Harvest | Cell Removal
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ScaleProduction | Large Scale
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".
Dimensions
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Filter Size10"(0.6 m² / 6.5 ft²)
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Filtration Area0.6 m² / 6.5 ft²
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Outer Diameter70 mm
General Specifications
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Capsule/Cartridge FormatCartridges
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Maximum Allowable Back Pressure2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C
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Maximum Diffusion15 mL/min at 1.5 bar | 22 psi
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Minimum Required Bubble Point2.0 bar | 29 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 MaterialCellulose Acetate (CA)
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Support FleecePolypropylene (PP)
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-filter0.65 μm
Product Information
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BrandSartobran®
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Pack Size1
Sterility/Purity
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Delivery ConditionNon sterile - Autoclavable | Steamable
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Sterilization MethodAutoclavable & In-Line Steam Sterilizable
Usage Protocols
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Sterilization Procedures
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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