0 1 2 3 4 5 GPM 0 5 10 15 20 LPM PRESSURE DROP (WATER) 0 40 80 120 160 200 ACFM 0 1133 2265 3398 4530 5662 ALPM PRESSURE DROP (AIR) MFE validation by Osmonics  is based upon the FDA Guidelines that we “establish documented evidence of assurance that a specif- ic process will consistently produce a product meeting its predetermined  specification  and  quality  attributes”  (FDA 1987).   MFE-S is designed for final sterile filtration of phar- maceutical products. MFE-S is designed for vent and process fluid filtration in val- idated systems where critical fluids need absolute, aseptic and sterile hydrophobic or chemically resistant protection. A detailed Validation Guide is available from Osmonics to document   our   rigorous   testing   for   your   records   and reviews. The   MFE-S   filter   is   just   one   example   of   our   strong commitment    to    the    pharmaceutical    industry. Our complete portfolio includes filters for every stage of pro- cessing,  and  we  offer  custom  solutions  for  your  unique applications. Osmonics is your complete source for filters, housings and other filtration equipment. * Gore  is a registered trademark of  W.L. Gore & Associates, Inc. Memtrex-FE-S (MFE-S) validatable sterilizing filter cartridges are designed for sterile filtration of pharmaceutical fluids. MEMTREX -FE-S FILTERS TM P T F E   M E M B R A N E (0.2 µm ABSOLUTE RATING) psid 8 7 6 5 4 3 2 1 0 bar 0.55 0.48 0.41 0.34 0.28 0.21 0.14 0.07 0 MFE-S ADVANTAGES Sterilization (S) grade MFE for validation uses High-purity Gore* membrane High throughput Meets  HIMA guidelines 100% integrity tested Steam sterilizable Meets  USP 23 Class VI Plastic Test Passes MEM Elution Cytotoxicity tested 0.2µm 0.2µm psid 1.5 1.0 0.5 0 bar 0.09 0.06 0.03 0 ACFM = SCFM 14.7 psia (psig + 14.7) ºF + 460 530 Note: For pressures and temperatures other than 14.7 psia (0 psig) and 70ºF,   ACFM can be approximated with the following formula: ACFM = Actual Cubic Feet per Min. ACFM = SCFM at 70º F and 14.7 pisa
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