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 and ensures sterilizing-grade venting performance in either direction.

Price (USD):
$232.00
Item No.: 
17805--------AIE

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

Product Information

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 sterilizinggrade venting performance in either direction. Sartopore® Air Midisart® delivers a high level of performance and process security.

Introduction

This filter sets the standards when it comes to requirements needed for critical applications. Particle retention, particle release limits, phage retention and of course bacteria retention in air and liquids (bi-directional) are specifications that prove the quality of Sartopore® Air Midisart®.

100% factory integrity testing ensures inherent quality in every filter prior to use. Superior and steady flow rates over long duration imply highly efficient processes. The absence of fleeces guarantees no particle release. Tubing kinking is no issue due to the proven light-weight construction.

Applications

  • Single-use assemblies
  • Small bioreactors
  • Carboys
  • Filling and transfer vessels
  • Holding and storage tanks | bags
  • Fill & finish applications
  • Bags | bottles | tubing assemblies
  • Mixers
  • Cell Culture Chambers

Inherent Quality Provides Full Confidence

The 0.2 μm single-layer hydrophobic polyethersulfone (PES) membrane is self-dewetting and therefore provides high air flow rates even at very low differential pressures over an extended process time. All components were developed and are produced under full control of Sartorius. Furthermore the following indispensable requirements are fulfilled:

  • Bi-directional sterility proven by worst case liquid
  • Bacterial Challenge Test in forward and reverse direction
  • Retention of ≥ 107 Brev. diminuta/cm2 in aerosol and liquid
  • Retention of ≥ 107 Bacteriophage MS2/cm2 in aerosol
  • Retention of particles sizes 0.005 μm | 0.3 μm
  • 100% integrity tested prior to release
  • Clear labeling with lot number, individual unit number and “IN” as an indicator for direction of flow.
  • All information lasered on the top part of each filter housing. No use of ink or glue labels.

Integrity Testing

  • Min. Bubble Point ≥ 950 mbar | 13.8 psi
  • Wetting agent: IPA/Water (60 | 40)

Sartopore® Air Midisart® guarantees intact filters released by a 100% pre-use test. For critical applications, we recommend the use of a filter tandem, as a pre-use test cannot fully cover the loading of the filter units in customer applications. A filter tandem greatly reduces the risk of a failed post-use integrity test if safety or other concerns arise.

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

  • Filtration Area
    20 cm² / 3 in²  

General Specifications

  • Capsule/Cartridge Format
    Midisart®  
  • Minimum Required Bubble Point
    > 950 mbar | 13.8 psi  

Materials of Construction

  • Filter Material
    Single-layer polyethersulfone (PES) membrane  
  • Housing Material
    Polypropylene (PP)  
  • 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
    12  
  • 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)  

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