Sartopore® 2 Gamma Midicaps® 0.2µm Size 0 | 2pc.

Tech Support Documents

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  • Effective Filtration Area: 0.45 m² | 4.8 ft²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Connectors: Inlet: Hose Barb ½“ single stepped | Outlet: Hose Barb ½“ single stepped
  • >Sterilization: Gamma-irradiatable
  • 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 = 0.065 m² | Size 8 = 0.13 m² | Size 9 = 0.26 m² | Size 0 = 0.52 m²

    Price (USD):
    $1,030.00
    Item No.: 
    5445307H0G-OO--V
    Availability: 
    *Custom/bulk order quotes are provided within 72 hours of request.

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    Sartopore® 2 Gamma Midicaps® were developed for use with bag containers prior to sterilization using gamma irradiation. <h3>Applications</h3>

    Typical applications include the sterile filtration and mycoplasma disposal of:

    • Biologicals
    • Pharma
    • Cell culture media (with and without serum)
    • Serum
    • Buffer
    • Culture media components
    <h3>Compatibility</h3>

    Sartopore® 2 Gamma Midicaps® have been developed for sterilization using gamma irradiation < in 50 kGy irradiation doses. The Sartopore® 2 polyethersulfone membrane has a high chemical compatibility between pH 1 to 14, making Sartopore® 2 Gamma Midicaps® ideally suited for the filtration of high and low pH buffers in pharmaceutical | Biotech Industry

    <h3>Performance</h3>

    Through "built-in prefiltration" in the form of a heterogeneous two-layer membrane, Sartopore® 2 Gamma Midicaps® achieve outstanding total flow and excellent flow rates.

    <h3>Flexibility</h3>

    Sartopore® 2 0.2 μm Midicaps® are supplied with different filtration areas of 500 cm² | 0.5 ft² to 0.45 m² | 5 ft² for easy adaptation to every filtration process regardless of batch size.

    <h3>Microbiological Retention</h3>

    Sartopore® 2 Gamma Midicaps® are completely validated as a sterile filter in accordance with HIMA ASTM F-838-05 guidelines. In addition, for mycoplasma retention, Sartopore® 2 Gamma Midicaps® are validated with an LRV of 7 for acholeplasma Laidlawii.

    <h3>Quality</h3>

    Each individual item was assigned before publication by a Bubblepoint and a diffusion test, integrity tested to ensure absolute reliability.

    <h3>Documentation</h3>

    Sartopore® 2 Gamma Midicaps® have been designed, developed and manufactured to comply with an ISO 9001 certified quality management system. A validation manual is available that meets regulatory requirements.

    Applications

    • Application
      High capacity platform for conventional sterile filtration
    • 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
    • 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
      1/2" Single Stepped Hose Barb
    • Connector Outlet
      1/2" Single Stepped Hose Barb
    • Connector(s)
      Hose barb 0.5" single stepped | Hose barb 0.5" single stepped

    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 and 2.5 bar | 36 psi: 0.05 m² | 0.5 ft²: 4 mL/min ; 0.1 m² | 1 ft²: 5 mL/min; 0.2 m²| 2 ft²: 7 mL/min; 0.45 m² | 4.5 ft²: 14 mL/min
    • Minimum Required Bubble Point
      3.2 bar | 46 psi
    • Vent Valve
      Standard

    Materials of Construction

    • Material o-ring | seal
      Silicone (SI)
    • Support Fleece
      Polyester (PET)

    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
      0.2 µm
    • Pore Size Pre-filter
      0.45 µm

    Product Information

    • Brand
      Sartopore® 2
    • Pack Size
      2
    • Type
      Size 0 | Connectors: OO

    Sterility/Purity

    • Sterilization Method
      Gamma Irradiatable

    Usage Protocols

    • Sterilization Procedures
      Gamma Irradiation: with 50 kGy, 1 Cycle
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