Sartofluor® Mini

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 User-Optimized 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.