EPM.F4 filter elements are produced on the basis of the hydrophobic fluoroplastic (PTFE) membrane with the micron rating of 0.2 μm. The hydrophobic cartridge with absolute filtration rating is designed for sterilizing filtration of air, gases and aggressive liquids in medical, pharmaceuticals, food and other industries. EPM.F4 filter elements have high flow rate and chemical compatibility.
Features |
Advantages |
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Fluoroplastic (PTFE) hydrophobic sterilizing membrane. |
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High strength of the structure of the filter element |
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100% control |
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Main applications
- Sterile filtration of air and gases in contact with the product.
- Systems of air supply.
- Ventilation of containers.
- At the input of filling devices.
- At the input and output of bioreactors.
- Sterile aeration of fermenters.
- Sterile purging of equipment.
- For filtration of aggressive liquids (acids, alkali, solvents, non-aqueous solutions, technical fluids) in the pH range of 1-14.
Cartridge materials
Membrane |
PTFE (Fluoroplast-4) |
Draining layer |
Polypropylene |
Body, end parts, adapter |
Polypropylene |
Supporting (encapsulated) adapter ring |
Stainless stee (on request) |
O-rings |
Silicone (Viton, FPM, EPDM, PTFE on request) |
Specifications
Pore size, μm |
0,20 |
Micron rating for air and gases |
‹0,02 μm |
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
---|---|---|
100 (4") |
70 |
0.35 |
250 (10") |
70 |
0.9 |
500 (20") |
70 |
1.8 |
750 (30") |
70 |
2.7 |
1000 (40") |
70 |
3.6 |
Operational parameters
Maximal differential pressure, MPa |
0,5 MPa при 20°C, 0,2 MPa at 80°C |
Maximal reverse differential pressure, MPa |
0,2 MPa at 20°C, 0,05 MPa at 80°С |
Maximal operational temperature, °C |
90°С |
Autoclaving |
121-132°С, 30-45 min., 100 cycles |
Steam sterilization |
121°С, 0.12 MPa, 30 min., 100 cycles 135°С, 0.2 MPa, 30 min., 50 cycles |
* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter RME.
EPM.F4 membrane-based filter elements are produced in accordance with the regulatory technical documents on product quality and are certified for use in the filtration processes of biopharmaceutical solutions. All EPM.F4 filter elements are subjected to purging from mechanical impurities with high-purity air and to 100% integrity control.
Final assembly and packaging of membrane filter cartridges is carried out in special clean rooms (ISO class 6 and 7) according to the classification of clean rooms in the pharmaceutical industry in accordance with EU GGMP.
EPM.F4 membrane filter elements undergo tests for bacterial and toxicological safety, materials used in the construction of filters have a minimal amount of extractable components and are approved for contact with intravenous drugs and food. Safety of filter cartridges is determined by a series of sanitary and chemical tests, and toxicology tests in compliance with GOST R ISO 10993.1-99, GOST R ISO 10993.5-99, GOST R ISO 10993.10-00.
Integrity test values of EPM.F4 with height 250 mm
Grade |
Max. Diffusion D, ml/min |
Permeability with aerosol particles (size 0.2-0.3 μm) at linear flow rate 1.0-1.7 cm3 /s·cm2* |
---|---|---|
EPM.F4-/020 |
20 |
not more than 0,0004% |
EPM.F4-020 |
30 |
not more than 0,0004% |
* This test fully correlates with the test for sterilization capability using the aerosol containing
Brevundimonas Diminuta bacteria with the concentration of 2х1010 CFU/cm2.
EPM.F4 Filter Cartridges ordering information
EPM.F4 |
020 |
D1 |
250 |
М |
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Grade |
Micron rating |
Adapter code |
Nominal height |
Application |
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020 = 0,2 μm 020/020 = 0,2 +0,2 μm |
D, D1, А1, А4 |
100 = 100 mm |
M – medical and biopharmaceutical industry P – food industry |