Sartopore® Air Midisart®

Tech Support Documents
Sartopore® Air Midisart® Sartopore® Air Midisart®
 

The Sartopore® Air Midisart® with its revolutionary hydrophobic 0.2 µm PES membrane completely addresses the rigorous demands of small-scale, single-use, venting applications. Sartopore® Air Midisart® ensures sterilizing-grade venting performance in either direction. Sartopore® Air Midisart® delivers a high level of performance and process security.

Item No.: 
17805--------AIN
Pieces
100

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

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Sartopore® Air Midisart®

For critical applications. Perfect for single-use assemblies.

  • Hydrophobic PES membrane
  • Gamma-irradiatable
  • Autoclaving (max. 3 cycles)
  • Liquid bacteria challenge test (bi-directionally)
  • 100% integrity tested
  • Clear laser labeling (no ink used)
  • No fleeces used
  • Superior flow rates

Critical Application Validation Package:

  • Aerosol bacteria challenge test
  • Aerosol phage challenge test
  • Aerosol particle challenge test
  • Particle release specification

Applications:

While Sartopore® Air Midisart® are designed for any kind of (critical) application, Midisart® 2000 cannot be gamma-irradiated (what is required for most single-use applications)

  • Filling and transfer vessels
  • Holding and storage tanks for sterile media
  • Autoclaves
  • Carboys
  • Solvent filtration
  • Mixers
  • Small (single-use) fermenters

Sartopore® Air recommended:

  • Single-use assemblies
  • Disposable bags/bottles
  • Tubing systems
  • Cell culture chambers
  • Fill & Finish applications

Applications

  • Application
    Air/Gas Filtration
  • Application Area
    • Single-use bioreactors (Sparge | Overlay filter assemblies | Exhaust filter assemblies)
    • Single-use mixing and storage bag vents
    • Single-use liquid filter assemblies requiring PUPSIT (Post Sterilization Pre-Use Integrity Testing)
    • Fill-finish
  • Industry
    Pharma / Biotech

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
    Hose Barb 6–12 mm Stepped
  • Connector Outlet
    Hose Barb 6–12 mm Stepped

Dimensions

  • 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
    > 950 mbar | 13.8 psi

Materials of Construction

  • Filter Material
    Single-layer polyethersulfone (PES) membrane
  • Material o-ring | seal
    Silicone
  • Membrane Material
    Polyethersulfone, Hydrophobic (PES)

Operating Conditions

  • Maximum Differential Pressure
    2 bar
  • Maximum Operating Pressure
    2 bar (29 psi)

Physicochemical Information

  • Gamma Stable
    Yes
  • 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
    0.2 µm
  • Pore Size Final-filter
    0.2 µm

Product Information

  • Brand
    Sartopore® Air Midisart®
  • Pack Size
    100
  • Packaging
    Non-sterile, bulk packed
  • Type
    Air filter

Sterility/Purity

  • Delivery Condition
    Non sterile - Gamma irradiatable
  • Sterilization Method
    Autoclavable & Gamma Irradiatable
  • Sterilizing Grade
    Yes

Usage Protocols

  • Sterilization Procedures
    • Gamma irradiation with max. 50 kGy.
    • Autoclaving: max. 134°C temperature for 30 min. (max. 20 cycles)
  • Midisart®
    Midisart®
    Item no.
    M_Midisart

    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.

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