Sartobran® P | Sartoscale 25 | 0.2µm | 6pc.

Tech Support Documents
Sartobran® P | Sartoscale 25 | 0.2µm | 6pc.
 

  • Effective Filtration Area: 4.5 cm²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Membrane Material: Cellulose Acetate
  • Connectors: Inlet: Female luer lock | Outlet: Male luer slip

Type
Item No.: 
5235307HV--LX--C
Availability: 
Pieces
6

*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

Sartoscale

SartoScale units are ideally suited for all types of filterability studies with the aim of selecting the optimal prefilter for an optimal application. Moreover, they can determine the ideal combination of pre- and final filters with the aid of a minimum product volume.

  • Developed for the execution of reliable filterability samples
  • Made from the same non-woven fabric material as the original filter cartridges
  • Ready-to-use single-use test filter unit

Membrane

Sartobran® P uses a double membrane made of Cellulose Acetate

Original filter material

SartoScale units contain the original filter active material of the corresponding filter cartridges to ensure the repeatability of test results.

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.

Ready to Use

Using SartoScale during filtration studies saves time which would otherwise be used for the installation preparations for the punch piece in the stainless steel filter brackets and prevents possible installation errors.

Scalability

After the material selection or the definition of a pre/final filter combination with the SartoScale units, a scale-up method should be carried out for the flow rate and total flow using pleated capsule units of small scales (e.g. capsule size 4).

Optimized design

SartoScale units have an extremely low residual volume for performing filterability samples with minimized product volumes.

Process Reliability

SartoScale test filter units are equipped with suitable filter membranes for integrity testing so that their integrity can be determined using the bubble point test in order to ensure absolute reliability of the test results.

Zero-T test system

We recommend using the SartoScale units together with the Zero-T Filter Test System to make the filtration studies as effective as possible. The Zero-T system consists of hardware and software modules which make it easy to handle and install Sartoscale test filter units. Automatic data collection is achieved by connecting a frame to a laptop. The software automatically analyzes the incoming data for the scale-up calculations.

User Manual

Directions for Use - Standard Filter Cartridges and Mini Cartridges
en 928.6 kB

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
    Female Luer Lock
  • Connector Outlet
    Male Luer Slip

Dimensions

  • Filter Size
    4.5 cm²
  • Filtration Area
    4.5 cm²

General Specifications

  • Capsule/Cartridge Format
    Sartoscale 25
  • 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

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
    6
  • Type
    4.5 cm² | Connectors: Luer | 6pc.

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable
  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: 1 cycle at max. 134 °C, 2 bar | 29 psi, 30 min.
  • Filter Holders
    Filter Holders
    Item no.
    A_Filter_Holders

    Sartorius offers a broad range of application-based solutions that fits laboratory needs as well as analytical testing outside the laboratory. To ensure best results different housings guarantee a burdenless workflow using various chemicals and solutions. Combined with the extraordinary quality of our membranes we make sure to simplify the progress of filtration steps in a convenient, easy-to-use manner that is highly individualized. Aside of that, large scale sustainability issues occurring due to the massive amount of single-use products are being tackled as the filter holders are made to be easily rinsed and autoclaved and, therefore, excellently suited in repetitive analyses.

  • Sartocheck® 5 Filter Tester
    Sartocheck® 5 Filter Tester
    Item no.
    26787---FT

    The Sartocheck® 5 Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.

  • Sartocheck® 5 Plus Filter Tester
    Sartocheck® 5 Plus Filter Tester
    Item no.
    26787---FT---P

    The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.

  • Sartoclean®
    Sartoclean®
    Item no.
    M_Sartoclean

    Sartoclean® family is a cellulose acetate (CA) membrane based prefilter. These filters are optimized for the protection of downstream equipment and Sartobran® cellulose acetate final filters.