Sartopore® 2 | Maxicaps® | 0.45µm | 20"

Tech Support Documents
Sartopore® 2 | Maxicaps® | 0.45µm | 20" Sartopore® 2 | Maxicaps® | 0.45µm | 20"
 

  • Effective Filtration Area: 1.2 m² | 12.9 ft²
  • Pore Size: 0.8 µm prefilter | 0.45 µm final filter
  • Membrane Material: Polyethersulfone
  • Connectors: Inlet: Sanitary 1 ½“| Outlet: Sanitary 1 ½“
  • Sterilization: Autoclavable

________________________

Connector explanation:

O = Hose Barb ½“ | S = Sanitary 1 ½“

Size explanation:

10” = 0.6 m² | 20” = 1.2 m² | 30” = 1.8m²

Filter Size
Type
Connector(s)
Item No.: 
5447306G2--SS
Availability: 
Piece
1

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

Choose your Sartopore® 2

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  • Extremely high flow rates and total throughputs
  • Number one choice for bioburden reduction & particle removal
  • Broad compatibility and easy scalability
  • Outstanding filtration performance of aqueoussolutions that are highly viscous & difficult to filter

Main Applications

Typical applications include bioburden and particle removal of:

  • Therapeutica
  • Injection solutions
  • Buffer
  • Biological Fluids
  • Tissue culture media
  • Acidic and alkaline solutions

Membrane

Sartopore® 2 uses a heterogeneous double membrane made of polyethersulfone

Compatibility

Sartopore®2 filters have been developed for sterilization using autoclaving at 134°C | 2bar. The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 filters ideal for filtering solutions with a high/low pH.

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

Sartopore® 2 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 Sartopore® 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.

Microbial Retention

Sartopore® 2 filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.

Documentation:

Sartopore® 2 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
    High capacity platform for conventional sterile filtration
  • Industry
    Pharma / Biotech
  • Modality
    • Downstream Intermediates
    • Harvest | Cell Removal
  • Scale
    Production | Large Scale

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
  • Connector(s)
    Inlet: 1 ½" Sanitary | Outlet: 1 ½" Sanitary

Dimensions

  • Filter Size
    20"(1.2 m² / 12.9 ft²)
  • Outer Diameter
    137 mm (110 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Maxicaps®
  • Maximum Allowable Back Pressure
    • 2 bar (29 psi) at 20°C
    • 1.5 bar (21.8 psi) at 50°C
  • Minimum Required Bubble Point
    2.2 bar | 32 psi
  • Vent Valve
    Standard

Materials of Construction

  • Housing Material
    Polypropylene (PP)
  • Material o-ring | seal
    Silicone (SI)
  • Membrane Material
    Polyethersulfone (PES)
  • 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
    0.45 µm
  • Pore Size Pre-filter
    0.8 µm

Product Information

  • Brand
    Sartopore® 2
  • Pack Size
    1
  • Type
    Inline (Autoclavable)

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable
  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles
  • Maxicaps® Filter Holders
    Maxicaps® Filter Holders
    Item no.
    M_MaxiCaps_Filter_Holders

    The Sartorius Stedim Biotech Maxicaps® holder has been specially designed to integrate Maxicaps® into biopharmaceutical processes.

  • 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.

  • Sartoguard
    Sartoguard
    Item no.
    M_Sartoguard

    All members of the Sartoguard family utilize a highly asymmetric polyether sulfone (PES) membrane double layer for unmatched protection of final filters and bioburden reduction with an LRV of 6 per cm². In addition, combinations with different depth filter materials and gamma sterilizable versions are available.