Midisart® 2000 0.45 µm

Tech Support Documents
Midisart® 2000 0.45 µm
 

The Midisart® 2000 is an ideal choice for small-scale sterile air | gas filtration applications. The single-layer hydrophobic PTFE membrane is self-dewetting and therefore provides high air flow rates even at very low differential pressures over an extended process time.

Item No.: 
17804--------NPE
Availability: 
Pieces
12

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

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Product Information

The Midisart® 2000 is a ready-to-use filter for sterilizing gases and venting. Superior flow rates and seamless integration into single-use assemblies provide Midisart® customers with a distinct advantage that directly translates into cost savings. Individual 100% factory integrity testing verifies the quality of every filter prior to use.

Midisart® 2000 is designed for maximum handling ease and safety. The device is lightweight only 20 g – so it will not weigh down or kink the tubing.

With a diameter measuring just 64 mm, Midisart® incorporates a filter area of 20 cm2, which means that it is “packed” with high flow rate performance power.

Midisart® 2000 filters can be integrity tested (Bubble Point Test, 60% IPA | Water, BP min. = 1.1 bar for 0.2 µm and BP min. = 0.9 bar for 0.45 µm). The Midisart® Test Manifold (Order code 1Z-LB-0002) can be used to test 10 filters in parallel which simply leads to a reduction of test time by 90%.

Venting Applications

  • Filling and Tranfer Vessels
  • Fermentation Carboys
  • Cell Culture Chambers
  • CO₂ incubators (6 to 120 liters)
  • Holding and Storage Tanks
  • Autoclave venting
  • Small Bioreactors

Applications

  • Application
    Air/Gas Filtration
  • Application Area
    • Filling and tranfer vessels
    • Fermentation carboys
    • Cell culture chambers
    • CO₂ incubators (6 to 120 liters)
    • Holding and storage tanks
    • Autoclave venting
    • Small bioreactors
  • Industry
    Pharma / Biotech / F&B

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
  • Biocompatibility (USP Class VI)
    USP<88>
  • 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
    1/8" NPT
  • Connector Outlet
    1/8" NPT

Dimensions

  • Filter Diameter
    64 mm | 2,5”
  • Filter Size
    20 cm² / 3 in²
  • Filtration Area
    20 cm² / 3 in²

General Specifications

  • Capsule/Cartridge Format
    Midisart®
  • Filter Format
    Capsules
  • Minimum Required Bubble Point
    For 0.2 µm min. Bubble Point > 1100 mbar | 15.95 psi, for 0.45 µm min. Bubble Point > 900 mbar | 13.05 psi , wetting agent: IPA | Water (60 | 40)

Materials of Construction

  • Filter Material
    Polytetrafluorethylene (PTFE)
  • Membrane Material
    Polytetrafluorethylene (PTFE)

Operating Conditions

  • Maximum Differential Pressure
    3 bar
  • Maximum Operating Pressure
    3 bar (44 psi)

Physicochemical Information

  • Gamma Stable
    No
  • 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
    0.45 µm
  • Pore Size Final-filter
    0.45 µm

Product Information

  • Brand
    Midisart®
  • Pack Size
    12
  • Packaging
    Sterile, individually packed
  • Type
    Air filter

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable
  • Sterilization Method
    Autoclavable
  • Sterilizing Grade
    Yes

Usage Protocols

  • Sterilization Procedures
    Max. Temperature 134 °C, max. Autoclaving 20 Cycles