Sartorius, 5235307H9--SS--A, Sartobran® P | Midicaps® | 0.2µm | Size 9 | 4pc.

Effective Filtration Area: 0.2 m² | 2.2 ft²
Pore Size: 0.45 µm prefilter | 0.2 µm final filter
Membrane Material: Cellulose Acetate
Connectors: Sanitary 1 ½“| Sanitary 1 ½“
Sterilization: Delivered sterile (Autoclaved)
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Sartobran® P with its unique low-binding cellulose acetate (CA) membrane is mainly used for the sterile filtration of blood & plasma products and vaccines. The ultra-low binding of the membrane material leads to highest product yield and exceptional filtration performance. Especially large, shear-stress sensitive proteins do not lose their structure and function when filtered through this special membrane. This will improve your product yield even further.
Main Applications
Coagulation factors, Albumin, lgG
Bacterial, viral & mRNA-based vaccines
Bioprocessed pharmaceuticals
Ophthalmics
Purified protein solutions
Biological fluids
Fluids containing preservatives
Membrane
Sartobran® P uses a double membrane made of Cellulose Acetate
Compatibility
Sartobran® P filters have been developed for sterilization using autoclaving at 134°C | 2bar. The Cellulose Acetate membrane is compatible within a pH range of 4 to 8, which makes the Sartobran® P filters ideal for most of the relevant biopharmaceutical applications.
Cost savings:
By using single-use filter elements, there is no need to invest in stainless steel filter housings. Additional costs for cleaning the housing and cleaning validation are eliminated.
Flexibility
Sartobran® P filters are available in different sizes and formats with corresponding filter areas from 4.5 cm² up to 1.8 m². Different connections allow easy integration into existing systems.
Scale Up:
Consistent and predictable scale-up and scale-down procedures can be performed safely because all Sartobran® P filter elements are manufactured with the same membrane type and construction materials.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Documentation:
Sartobran® P filters have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements.

Specifications
Applications:
Application: Blood and Plasma; Vaccine Production
Modality: Harvest | Cell Removal; Downstream Intermediates; Form & Fill

Biological Information:
Bacterial Retention: Quantitative 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
Biological Reactivity: All 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).
Extractables: The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

Connections (Physical):
Connector Inlet: 1.5" Tri-clamp 50 mm
Connector Outlet: 1.5" Tri-clamp 50 mm

Dimensions:
Filter Size: size 9 (0.2 m² / 2.2 ft²)
Filtration Area: 0.2 m² / 2.2 ft²
Outer Diameter: 108.5 mm (77 mm without Connection / Valves)

General Specifications:
Capsule/Cartridge Format: Midicaps®
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Maximum Diffusion: 5 mL/min at 2.5 bar | 36 psi
Minimum Required Bubble Point: 3.2 bar | 46 psi
Vent Valve: Standard

Materials of Construction:
Filter Material: Cellulose Acetate (CA)
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Cellulose Acetate (CA)
Support Fleece: Polypropylene (PP)

Operating Conditions:
Maximum Differential Pressure: 20 °C: 5 bar, 50 °C: 3 bar
Maximum Operating Pressure: 5 bar (72.5 psi)

Physicochemical Information:
Non-Fiber Releasing: This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
Pore Size Final-filter: 0.2 µm
Pore Size Pre-filter: 0.45 µm

Product Information:
Brand: Sartobran® P
Pack Size: 4

Sterility/Purity:
Delivery Condition: Sterile - Autoclaved
Sterilization Method: Autoclavable

Usage Protocols:
Sterilization Procedures: Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles