Sartopore® 2 Midicaps® 0.45µm size 0 | 2pc

Tech Support Documents
Sartopore® 2 Midicaps® 0.45µm size 0 | 2pc Sartopore® 2 Midicaps® 0.45µm size 0 | 2pc Sartopore® 2 Midicaps® 0.45µm size 0 | 2pc
 

  • Effective Filtration Area: 0.45 m² | 4.8 ft²
  • Pore Size: 0.8 µm prefilter | 0.45 µm final filter
  • Connectors: Inlet: Sanitary ¾“ | Outlet: Sanitary ¾“
  • Sterilization: Delivered sterile (Autoclaved)
  • Membrane Material: Polyethersulfone
  • Pack Size: 2 pieces

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Connector explanation:

O = Hose Barb ½“ | S = Sanitary 1 ½“ | H = Hose Barb ¼“ | F = Sanitary ¾“

Size explanation:

Size 7 = 0.05 m² | Size 8 = 0.1 m² | Size 9 = 0.2 m² | Size 0 = 0.45 m²

Price (USD):
$888.00
Item No.: 
5445306G0--FF--V
Availability: 

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

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Sartopore® 2 0.45 μm MidiCaps® are self-contained, ready-to-use filter elements for bioburden and particle removal for a wide range of pharmaceutical products. Membrane prefiltration of aqueous solutions and high-value pharmaceutical products that are difficult to filter can be performed effectively, due to the excellent overall flow and flow rate performance of the Sartopore® 2 0.45 μm MidiCaps®.

  • Single-Use MidiCaps® for Process Scale
  • Reduction of Cleaning & Cleaning Validation
  • Familiar performance characteristics of the Sartopore® 2

Applications:

Typical applications include bioburden and particle removal of:

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

Compatibility:

The polyethersulfone membrane is compatible within a pH range of 1-14. This makes the Sartopore® 2 MidiCaps® ideal for filtering solutions with a high/low pH.

Easy to use:

Sartopore® 2 MidiCaps® are supplied as single and sterile packaged, ready-to-use units, eliminating the need for sterilization prior to use.

Flexibility:

Sartopore® 2 0.45 μm MidiCaps® are supplied with a wide range of filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 4.5 ft² and with various connections to ensure easy adaptation to your application filtration needs regardless of batch size.

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.

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.

Microbiological retention:

Sartopore® 2 MidiCaps® 0.45 μm were validated with a Log Reduction Value (LRV) of 7 for "Serratiam marcessens" according to HIMA and ASTM F-838-05 specifications.

Quality:

Every single element is tested for integrity to meet the highest quality requirements.

Documentation:

Sartopore® 2 MidiCaps® 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

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
    3/4" Tri-clamp 25 mm
  • Connector Outlet
    3/4" Tri-clamp 25 mm

Dimensions

  • Filter Size
    size 0 (0.45 m² / 4.8 ft²)
  • Filtration Area
    0.45 m²
  • 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
    at 20 °C: 0.05 m² | 0.5 ft²: 3 mL/min at 1.7 bar | 25 psi; 0.1 m² | 1 ft²: 4 mL/min at 1.7 bar | 25 psi; 0.2 m² | 2 ft²: 6 mL/min at 1.7 bar | 25 psi; 0.45 m² | 5 ft²: 12 mL/min at 1.7 bar | 25 psi
  • Minimum Required Bubble Point
    2.2 bar | 32 psi
  • Vent Valve
    Standard

Materials of Construction

  • 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
    2
  • Type
    Size 0 | Connectors: FF

Sterility/Purity

  • Delivery Condition
    Sterile - Autoclaved
  • Sterilization Method
    Autoclavable

Usage Protocols

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