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

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

  • 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

  • ________________________________________

    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):
$1,000.00
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.

Applications

Typical applications include the sterile filtration and mycoplasma disposal of:

  • Biologicals
  • Pharma
  • Cell culture media (with and without serum)
  • Serum
  • Buffer
  • Culture media components

Compatibility

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

Performance

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.

Flexibility

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.

Microbiological Retention

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.

Quality

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

Documentation

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