Sartobran® P | Mini Cartridge | 0.2µm | Size 9 | 5pc.

Tech Support Documents
Sartobran® P | Mini Cartridge | 0.2µm | Size 9 | 5pc. Sartobran® P | Mini Cartridge | 0.2µm | Size 9 | 5pc.
 

  • Effective Filtration Area: 0.2 m² | 2.2 ft²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Membrane Material: Cellulose Acetate
  • Sterilization: In-line steamable | Autoclavable
  • Adapter: Bayonet
  • O-ring material: Silicone

Type
Price (USD):
$1,200.00
Item No.: 
5231507H9------B
Availability: 
Pieces
5

*Custom/bulk order quotes are provided within 72 hours of request.

Choose your Sartobran® P

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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

Sartopore®2 Cartridges have been developed for sterilization using either autoclaving or in-line-steaming. 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.

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
    Bayonet Adapter with O-ring (15)

Dimensions

  • Filter Size
    size 9 (0.2 m² / 2.2 ft²)
  • Filtration Area
    0.2 m² / 2.2 ft²
  • Outer Diameter
    56 mm

General Specifications

  • Capsule/Cartridge Format
    Mini Cartridges
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C
  • Maximum Diffusion
    5 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.2 bar | 46 psi
  • Vent Valve
    N/A

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, 80 °C: 2 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®
  • Pack Size
    5
  • Type
    Mini Cartridge | Size 9

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable | Steamable
  • Sterilization Method
    Autoclavable & 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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