Sartofluor PTFE Filter Cartridges - Psfiltración

1 Sartofluor PTFE. Filter Cartridges Scalable and secure performance in sterile venting Choose Sartofluor PTFE for optimum air filtration The optimum means. User-Optimized. Optimum choice for sterile venting The air Filter as a barrier needs to be highly The development of this extremely reliable, and gas applications. reliable under all circumstances, pressure secure, "last chance" barrier Filter included Specify Sartofluor cartridge systems to pulses, high steaming cycles, elevated moisture the experiences of our Research and Develop- optimize filtration performance in sterile content etc.

2 That's why we optimized our ment, engineering groups, suppliers, and venting and gas applications such as: Sartofluor air Filter Cartridges to meet all the especially our customers. Their input was Sterile gas filtration of fermentor inlets requirements with highest assurance levels. and is our most valuable resource to find Off-gas filters downstream of fermentors the optimum performance. or bioreactors Sartofluor Filter Cartridges fulfill all demands Sterilizing vent filters on autoclaves and placed on an air Filter , such as: The optimum includes: Iyophylizers (freeze dryer). Highest hydrophobicity Optimized, durable construction Sterile vent filters on product and WFI tanks High flow rates at low differential pressures PTFE membrane Sterile air supply for service gases, such as High steam cycle lifetimes High void volume filling lines in blow-fill-seal machines High mechanical and thermal strength Optimized selection of prefilter and Reliable and validated separation of support fleece Sartofluor Cartridges are available in the microorganisms and bacteriophage Maximized filtration area optimum range of pore sizes - m, Optimal pleat density m and m.

3 Scale up with a complete product line for air filtration Dependable performance at every scale. Optimized construction adds savings. Materials of construction The Sartorius scale-up philosophy does not Experience, testing and customer feedback Prefilter Layer Polypropylene stop at liquid filtration. Especially in air filtra- have guided the evolution of Sartofluor tion, with its variety of applications and Cartridges . For example, membrane pleatings Membrane Filter PTFE. demands, different Filter sizes are essential. and layers of Filter fleece have been chosen Drainage Layer Polypropylene Sartofluor Filter Cartridges are available from to avoid water logging.

4 Attention to detail 300 m2 to cm2 for single Filter elements, at this level means you realize added savings Outercage Polypropylene which means you can effectively Filter air in low blow down times. Inner Core Polypropylene from small volume bioreactor to seed and large scale fermentor venting, as well as Endcaps Polypropylene tank venting. O-Rings Silicone*. The right hydrophobicity. * EPDM and Viton are available 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.

5 Sartorius Sartofluor membranes are constructed of PTFE. It provides more than twice the hydrophobicity of polypropylene |1 Capsules 150. or PVDF. |2 Mini Cartridges |3 Standard Cartridges |4 MaxiCaps |5 Standard MidiCaps |6 Sartofluor Junior |5. |2. |1. |4. |6. |3. Top Performance even after 150 steam sterilization cycles Mechanical strength and optimized No water blockage. High flow rates. construction. Maximum savings. We've tested Sartofluor Cartridges to 134 C In air filtration applications, high flow rates and they all withstood 150 steam cycles. result in lower energy costs and help to maxi- No loss in integrity or performance.

6 Or in PTFE mize safety for example, for tank, venting. hydrophobicity. No loss in flow rate. Plus, Sartofluor Cartridges are optimized to main- optimized Sartofluor cartridge construction tain high flow rates, even in challenging allows differential pressures up to bar at process conditions likel condensate build-up 134 C. This exceptional performance has been in steam-venting or elevated moisture confirmed by Bacterial Challenge testing. content. No cartridge does more to control life-cycle costs. No cartridge system is more cost-effective. Differential Pressure Limits at given The Reason: Sartofluor PTFE membrane and temperatures support fleece are extremely hydrophobic and feature optimized pleat density.

7 In the Direction of Filtration The Result: effective drainage of condensate C 20 121 134 140. and no water blockage. bar 5 Validated performance for assured security. Sartofluor Cartridges fulfill all known current Opposite the Direction of Filtration regulatory requirements, for example C 20 12 34 140 USP, cGMP and FDA. This is documented in our Validation Guidelines for Sartofluor bar 3 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.

8 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 extractables tests done using RP-HPLC, GC-MS and FTIR. They pass phage challenge tests that last as long as 7 days. Integrity Testing Why the biopharmaceuticai industry The Simplicity of the WIT Procedure. chose the Sartorius Water Intrusion The upstream side of the Filter housing is Test (WIT).

9 Filled with water and the air volume above Sartorius was the first to develop and the water column is measured. Afterwards a validate an in-place integrity test for test pressure of bar is applied and the sys- hydrophobic air Filter Cartridges -the WIT. tem stabilized for 10 min. During the 10 min test time, the pressure drop is measured, It surpasses other integrity tests because: which happens due to the intrusion of water It utilizes water as a test medium instead into the first layers of the membrane. With of a solvent water mixture. the measured volume and pressure drop and It can be performed in place, after steam the known test time, the intrusion is calculat- sterilization.

10 Ed and compared to the maximum allowable The WIT tests the complete system housing, intrusion quoted in the validation guides. O-rings, valves and Filter elements including Filter integrity and hydrophobicity. No downstream manipulations are required. Contamination by solvents or oil aerosols is avoided. The WIT can be fully automated, or it may be performed manually or semi- automatically. It is directly correlated to the ASTM Bacteria Challenge Test. The test pressure for the WlT, at bar (36 psi), is far lower than the Water Penetration Pressure, which is around bar (67 psi) for a Sartofluor ( Sartofluor m).