Sartofluor® Cartridge

Sartofluor® Cartridge 5182507T0----GA

Sterilizing-grade air filter cartridges for bio-pharmaceutical applications.
  • Specially designed for sterile venting and gas applications where adherence to cGMP´s is a must
  • Manufactured with permanently hydrophobic PTFE membranes
  • Highest process security, even with high-volume gas streams, extreme humidity and stringent in-line steam sterilizations
  • Ideally suited for applications requiring a sterile, hydrophobic gas filter

Description

Sartofluor GA filter cartridges, manufactured with permanently hydrophobic PTFE membranes, are specially designed for sterile venting and gas applications where adherence to cGMP´s is a must. Due to their permanent hydrophobicity, Sartofluor GA cartridges offer the highest process security, even with high-volume gas streams, extreme humidity and stringent in-line steam sterilizations. Sartofluor GA cartridges are ideally suited for applications requiring a sterile, hydrophobic gas filter such as: – Fermenter and bioreactor inlet gasses – Fermenter and bioreactor vents – Autoclave vents – Lyophilizer vents – Purified water system storage tank vents – In-process storage tank vents – Filling equipment process air. PTFE is the most hydrophobic of all membranes used in sterile filtration of gasses. The inherent hydrophobicity of the PTFE membrane remains unaffected by repeated autoclaving or steaming. The sterile filtration of dry or moist gasses is guaranteed. The unique single-layer design is optimized for high flow rates at low differential pressures with short blow down times. Sartofluor GA can withstand high differential pressures in either the forward or reverse direction of flow. The mechanical stability and membrane structure are not affected by pulsation or high flow rates. A Sartorius development, the WFT offers the first and only correlated in-situ integrity testing system for hydrophobic vent filters. WFT not only eliminates downstream intervention and preflushing, more importantly, it does not require a single drop of alcohol. Each individual element is tested for integrity prior to release assuring absolute reliability. Sartofluor GA cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Applications:

Sartofluor GA cartridges are ideally suited for applications requiring a sterile, hydrophobic gas filter such as:

  • Fermenter and bioreactor vents
  • Autoclave vents
  • Lyophilizer vents
  • Purified water system storage tank vents
  • In-process storage tank vents
  • Filling equipment process air

Performance:

PTFE is the most hydrophobic of all membranes used in sterile filtration of gases. The inherent hydrophobicity of the PTFE membrane remains unaffected by repeated autoclaving or steaming. The sterile filtration of dry or moist gases is guaranteed. The unique single layer design is optimized for high flow rates at low differential pressures with short blow down times.

Stability:

Sartofluor GA can withstand high differential pressures in either the forward or reverse direction of flow. The mechanical stability and membrane structure are not affected by pulsation or high flow rates.

Water Intrusion Test (WIT)| Water Flow Test (WFT):

A Sartorius development, the WFT offers the first and only correlated in-line integrity testing system for hydrophobic vent filters. WFT not only eliminates downstream intervention and preflushing, more importantly, it does not require a single drop of alcohol.

Quality Control:

Each individual element is tested for integrity prior to release assuring absolute reliability.

Documentation:

Sartofluor GA cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Product properties

Branch
Pharma / Biotech
Filter Type
Filter Cartridges
Type
Air filter
Filtration area
0,45 m²
Membrane filter material
PTFE

Technical attributes

Support Layers
Polypropylene (PP)
Structural Compounds
Polypropylene (PP)
O-ring
Silicone (optional EPDM or Fluoroelastomer)
Min. required Bubble Point
1,0 bar | 15 psi
Max. allowed air diffusion
11 ml/min at 0.7 bar | 10 psi at 20 °C per 10 inch element
Bacterial Retention
Quantitative retention of 1 x E7 CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM methodology
Bacterial Endotoxins
<0.25 EU/mL as determined by the LAL test
Extractables
Product meets or exceeds the Quality standards set for "Sterile Water for Injection" by the current USP.
Biosafety
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).
Sterilisation
In-Line Steam Sterilization: Min. 150 cycles at 134 °C, 20 min. at max differential pressure of 0.5 bar | 7 psi
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.
GMP Compliance
The product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Membrane material
Polytetrafluorethylene (PTFE)
Max. Differential Pressure
20 °C: 5 bar; 80 °C: 2 bar
Adapter
25 ( S-adapter top, locking bayonet adapter with 226 double O-ring bottom)

Brochure

Order number:

5182507T0----GA

Amount: more less
Price: on request
Send request

More information

Contact

Share



Back