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- Sartobran® P | 0.45 µm | Maxicaps® (Production | Large Scale)
Sartobran® P | Maxicaps® | 0.45µm | 20"
Sartobran® P 0.45 µm Maxicaps offer efficient bioburden and particle reduction for large-scale production. The cellulose acetate membrane minimizes adsorption, ensuring high product recovery. Ideal for vaccines and plasma, they support high throughput and consistent flow.
- Item No.:
- 5237306D2--SS
- Piece
- 1
Sartobran® P 0.45 µm Maxicaps offer efficient bioburden and particle reduction for large-scale production. The cellulose acetate membrane minimizes adsorption, ensuring high product recovery. Ideal for vaccines and plasma, they support high throughput and consistent flow.
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.
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".
Connections (Physical)
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Connector Inlet1.5" Tri-clamp 50 mm
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Connector Outlet1.5" Tri-clamp 50 mm
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Connector(s)Inlet: 1 ½" Sanitary | Outlet: 1 ½" Sanitary
Dimensions
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Filter Size20"(1.2 m² / 12.9 ft²)
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Filtration Area1.2 m² / 12.9 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 Pressure2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
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Maximum Diffusion30 mL/min at 1.5 bar | 22 psi
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Minimum Required Bubble Point2.0 bar | 29 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 MaterialCellulose Acetate (CA)
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Support FleecePolypropylene (PP)
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-filter0.45 μm
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Pore Size Pre-filter0.65 μm
Product Information
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BrandSartobran® P
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Pack Size1
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TypeInline (Autoclavable)
Sterility/Purity
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Delivery ConditionSterile - Autoclaved
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Sterilization MethodAutoclavable
Usage Protocols
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Sterilization ProceduresAutoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles