Sartopore® Air Gamma Maxicaps 10'' IT

Tech Support Documents
Sartopore® Air Gamma Maxicaps 10'' IT
 

The Sartorius Sartopore® Air with its revolutionary hydrophobic 0.2 μm PES membrane completely addresses the rigorous demands of single-use venting applications and delivers a high level of performance and process security.

Connector(s)
Price (USD):
$1,110.00
Item No.: 
5197307A1G-OOIT
Availability: 
Piece
1

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

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Product Information

The Sartopore® Air raises the bar and sets the standards when it comes to the requirements needed for single-use applications. Particle retention, phage retention and of course bacterial retention in air and liquid are specifications that prove the quality of Sartopore® Air. 100% factory integrity testing ensures inherent quality in every filter prior to use. Superior and steady flow rates over long duration imply high efficient processes.

Applications

  • 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

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 at 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:

  • Retention of ≥ 107Brev. 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 labelling with Lot. number and individual unit number.

All information lasered on each filter housing.

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).

Connections (Physical)

  • Connector Inlet
    1/2" Single Stepped Hose Barb
  • Connector Outlet
    1/2" Single Stepped Hose Barb
  • Connector(s)
    0.5" Single stepped hose barb | 0.5" Single stepped hose barb

Dimensions

  • Filter Size
    10"(0.53 m² / 5.7 ft²)
  • Filtration Area
    0.53 m² | 5.7 ft²

Features

  • Venting Filter
    Yes

General Specifications

  • Capsule/Cartridge Format
    Maxicaps®
  • Vent Valve
    IT Compatible

Materials of Construction

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

Physicochemical Information

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

Product Information

  • Brand
    Sartopore® Air
  • Pack Size
    1

Sterility/Purity

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

Usage Protocols

  • Sterilization Procedures
    Gamma irradiation with max. 50 kGy.
  • Venting Filter Housings
    Venting Filter Housings
    Item no.
    M_Venting_Filter_Housings

    Sartorius Stedim Biotech Sanitary Filter Housings are specifically designed for air | gas filtration applications of the Bio-Pharmaceutical Industry.

    Application: tanks and vessels

  • 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.

  • Sartocheck® 5 Filter Tester
    Sartocheck® 5 Filter Tester
    Item no.
    26787---FT

    The Sartocheck® 5 Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.

  • Confidence® Validation Services
    Confidence® Validation Services
    Item no.
    M_Confidence_Validation_Services

    Confidence® offers a wide range of validation studies according to regulatory requirements and customer's needs.