A detailed Validation Guide is available from GE to document our rigorous testing for your records and reviews. The guide includes all the data necessary to assist the user with compliance to regulatory requirements.
The inherently hydrophobic MFE-S filter is just one example of our strong commitment to the pharmaceutical industry. Our complete portfolio includes filters for every stage of processing, and we offer custom solutions for your unique applications. GE is your complete source for filters, crossflow membranes, housings and other filtration equipment.
Integrity Testing
Air diffusion per 10″ module after saturation with 60% IPA/40% water (by volume) solution. ≤10cc/min at 13 psig (0.90 bar). Memtrex FE-S filters meeting this specification have been demonstrated to provide sterile effluent based on B. Diminuta Challenge Testing using ASTM F838-83 methodology.
Note
Trademark of General Electric Company; may be registered in one or more countries.
Typical Applications
MFE-S filters are specifically designed for sterile chemical, air, gas and vent filtration. Typical applications include:
- Tank Venting
- Fermentation Air Supply
- WFI Tanks
- Autoclaves
- Chemicals
- Bioreactors
General Properties
Memtrex FE-S filters are available in the following absolute pore size micron rating: 0.2 µm. Tables 1, 2, 3, 4 and 5 show further details on materials of construction, dimensions, operational limits, and flow performance in air and water.
Additional Information
- Memtrex-FE-S filters may be autoclaved at 249.8°F (121°C) or in-situ steam sterilized at 275°F (135°C) for up to 100 one-hour cycles. Steam resistance was determined using clean filters in controlled conditions; actual steam resistance may be affected by application conditions. Alternatively, the filters may be sanitized with compatible chemical agents.
- GE certifies that the material contained in its Memtrex FE-S pleated filters meet U.S. FDA requirements for food contact under the applicable regulations in 21 CFR. For further information, contact GE technical services. Memtrex FE-S filters meet the test criteria for USP class VI-121°C Plastics.
- Aqueous extracts from Memtrex FE-S filters contain less that 0.25 EU/ml. The filters typically exhibit low levels of non-volatile residues.
- GE filter cartridges are designed and manufactured for resistance to a wide range of chemical solutions. Conditions will vary with each application and users should carefully verify chemical compatibility. Please contact your GE distributor for more information.