Sartofluor® is the solution for all applications where sterile air is needed. A single-layer PTFE membrane construction ensures validated sterility, while providing maximum flow rate over a wide range of operating conditions. The optimal performance-to-cost ratio allows benefiting from the lowest cost-of-ownership for air/gas and aggressive solvent filtration.
Order Number: 5181807T9------B
Availability: On Request
Sartofluor® are sterilizing grade air & gas filters that utilize Polytetrafluorethylene (PTFE) membranes. PTFE is a chemically extremely resistant membrane material which is also suitable for highly aggressive solvents. The optimized construction leads to a perfect hydrodynamic flow.
Requirements of Air/Gas Filtration
The air filter as a barrier needs to be highly reliable under all circumstances, i.e. pressure pulses, high steaming cycles, elevated moisture content etc. That’s why we optimized our Sartofluor® air filter cartridges to meet all the requirements with highest assurance levels.
- Highest hydrophobicity
- High flow rates at low differential pressures
- High steam cycle lifetimes
- High mechanical and thermal strength
- Reliable and validated separation of microorganisms and bacteriophage
The development of this extremely reliable, secure, “last chance” barrier filter included the experiences of our Research and Development, engineering groups, suppliers, and especially our customers. Their input was and is our most valuable resource to find the optimum performance.
Optimum choice for sterile venting and gas applications
- Sterile gas filtration of fermenter inlets
- Off-gas filters downstream of fermenters or bioreactors
- Sterilizing vent filters on autoclaves and Iyophylizers (freeze dryer)
- Sterile vent filters on product tanks
- Sterile air supply for service gases, such as filling lines in blow-fill-seal machines
Sartofluor® cartridges are available in the optimum range of pore sizes – 0.45 µm, 0.2 µm and 0.1 µm.
Dependable performance at every scale
Our scale-up philosophy does not stop at liquid filtration. Especially in air filtration, with its variety of applications and demands, different filter sizes are essential. Sartofluor® filter cartridges are available from 300 m² to 2.3 cm² for single filter elements, which means you can effectively filter air from small volume bioreactor to seed and large scale fermenter venting, as well as tank venting.
The right hydrophobicity
If the filter membrane is not hydrophobic enough, moisture can accumulate and microorganisms may grow. A highly hydrophobic membrane can eliminate this danger along with any risk of water logging. Sartofluor membranes are constructed of PTFE. It provides more than twice the hydrophobicity of polypropylene or PVDF.
Optimized construction adds savings
Experience, testing and customer feedback have guided the evolution of Sartofluor cartridges. For example, membrane pleatings and layers of filter fleece have been chosen to avoid water logging. Attention to detail at this level means you realize added savings in low blow down times.
Mechanical strength and optimized construction
We‘ve tested Sartofluor cartridges to 134°C and they all withstood 150 steam cycles. No loss in integrity or performance. Or in PTFE hydrophobicity. No loss in flow rate. Plus, optimized Sartofluor cartridge construction allows differential pressures up to 0.5 bar at 134°C. This exceptional performance has been confirmed by Bacterial Challenge testing.
No water blockage. High flow rates. Maximum savings.
In air filtration applications, high flow rates result in lower energy costs and help to maximize safety – for example, for tank, venting. Sartofluor® cartridges are optimized to maintain high flow rates, even in challenging process conditions like condensate build-up in steam-venting or elevated moisture content. No cartridge does more to control life-cycle costs. No cartridge system is more cost-effective. The Reason: Sartofluor® PTFE membrane and support fleece are extremely hydrophobic and feature optimized pleat density. The Result: effective drainage of condensate and no water blockage.
Validated performance for assured security
Sartofluor® cartridges fulfill all known current regulatory requirements, for example USP, cGMP and FDA. This is documented in our Validation Guidelines for Sartofluor filter cartridges. Besides the validation, Sartofluor® cartridges undergo a stringent performance qualification procedure:
- They’re pressure-pulsation tested for 5000 cycles at 5 bar differential pressure.
- They’re steam-cycle evaluated for 150 cycles at 134°C for 30 min; then 11 additional cycles over 7 hours.
- Their flow rate and water penetration are measured only after defined steam cycling.
- They’re tested at maximum allowable differential pressure at a full range of temperatures.
- Their blow-down time is measured after steam sterilization and Water Intrusion Testing.
- They pass extractable tests done using RP-HPLC, GC-MS and FTIR.
- They pass phage challenge tests that last as long as 7 days.
Capsule/Cartridge FormatMini Cartridges
Filter Sizesize 9 (0.2 m² / 2.2 ft²)
Connector OutletPlug Adapter with Double O-ring (18)
Connector InletPlug Adapter with Double O-ring (18)
Filtration area0.2 m²
Pore size final-filter0.2 µm
Material o-ring | sealSilicone (SI)
Sterilization ProceduresIn-Line Steam Sterilization=== Min. 25 cycles at 134 °C, 30 min. at max differential pressure of 0.3 bar| 5 psi` Autoclaving === min 25 cycles at 134 °C, 2 bar|29 psi, 30 min or other parameters to be specified
Sterilization MethodAutoclavable & In-Line Steam Sterilizable
Bacterial Endotoxins< 0.25 EU/mL as determined by the LAL test
Bacterial RetentionQuantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
GMP ComplianceThis product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
Maximum Differential Pressure20 °C=== 5 bar; 80 °C=== 2 bar
BiosafetyAll 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).
ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Non-Fiber ReleasingThis filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
Housing materialPolypropylene (PP)
Support FleecePolypropylene (PP)
Min. required Bubble Point1.0 bar
Max. diffusion4 mL/min at 0.7 bar