Sartofluor^® Cartridge 5182506T2----LG

Specially designed for sterile filtration of aggressive media (acids and bases) and solvents where adherence to cGMP´s is a must

Manufactured with permanently hydrophobic PTFE membranes

Ideally suited for applications requiring a sterile, hydrophobic gas filter

Description

Sartofluor LG filter cartridges, manufactured with permanently hydrophobic PTFE membranes, are specially designed for sterile filtration of aggressive media (acids and bases) and solvents where adherence to cGMP´s is a must. Due to their permanent hydrophobicity, Sartofluor LG cartridges offer the highest process security. LG stands for Liquid and Gas applications, that means Sartofluor LG suits also in gas or vent applications where no high air flow rates are required. The membrane is the same as used in the gas filter cartridge Sartofluor GA. Performance: 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. Stability: Sartofluor LG 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-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. Quality control: Each individual element is tested for integrity prior to release assuring absolute reliability. Documentation: Sartofluor LG 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 LG filter cartridges, manufactured with permanently hydrophobic PTFE membranes, are specially designed for sterile filtration of aggressive media (acids and bases) and solvents where adherence to cGMP´s is a must. LG stands for Liquid and Gas applications, that means Sartofluor LG suits also in gas or vent applications where no high air flow rates are required.

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 LG 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-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.

Quality Control:

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

Documentation:

Sartofluor LG 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	Cartridge
Type	Membrane filter
Pore size	0,45 µm
Adapter	25 ( S-adapter top, locking bayonet adapter with 226 double O-ring bottom)
Filtration area	1,2 m²

Technical attributes

Support Layers	Polypropylene (PP)
Structural Compounds	Polypropylene (PP)
O-ring	Silicone
Min. required Bubble Point	1.0 bar \| 15 psi
Max. allowed air diffusion	7 ml/min at 0.7 bar \| 10 psi at 20 °C per 10 inch element
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.
Max. Differential Pressure	20 °C: 5 bar; 80 °C: 2 bar
Depth filter material	PTFE
Membrane material	Polytetrafluorethylene (PTFE)