EPM.F filter elements are produced on the basis of a two-layer hydrophobic fluoroplastic (PVDF + PTFE) membrane with a pore size of 0.45-0.8 μm. Filter elements have high flow rate and chemical resistance to acids and solvents. Recommended to use for fine filtration of gaseous media and aggressive fluids.
Cartridge materials
|
Membrane |
Fluoroplastic hydrophobic (PVDF+PTFE) |
|
Prefilter membrane |
Fluoroplastic hydrophobic (PVDF+PTFE) |
|
Draining layer |
Polypropylene |
|
Body, end parts, adapter |
Polypropylene |
|
O-rings |
Silicone (others on request) |
Specifications
|
Pore size, μm |
Ordering code |
|---|---|
|
0,65+0,45 |
065/045 |
|
0,65 |
065 |
|
0,8+0,45 |
080/045 |
|
0,8 |
080 |
Nominal dimensions
|
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
|---|---|---|
|
100 (4") |
70 |
0.23 |
|
250 (10") |
70 |
0.62 |
|
500 (20") |
70 |
1,24 |
|
750 (30") |
70 |
1.86 |
|
1000 (40") |
70 |
2.48 |
Operational parameters
|
Maximal differential pressure, MPa |
0,5 MPa at 20°C, 0,2 MPa at 80°C |
|
Maximal operational temperature, °C |
80°С |
|
Recommended gas flow rate (at 7 bar) for the cartridge of 250 mm height, m3/h |
300 |
|
Autoclaving |
121°С, 0.12 MPa, 30 min., 50 cycles |
|
Steam sterilization |
121°С, 0.11 MPa, 30 min., 10 cycles |
* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter RME.
EPM.F 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.F filter elments are subjected to purging from mechanical impurities with high-purity air and to 100% integrity control.
Wash out, integrity control, drying, 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.F 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 elements 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
Integrity test values of EPM.F when using automatic control systems
|
Марка |
Bubble point (ethanol), MPa (bar), not less |
|---|---|
|
EPM.F-/045 |
0,036 (0,36) |
|
EPM.F-/065 |
0,03 (0,3) |
|
EPM.F-/080 |
0,02 (0,2) |
*All values are given for the filter cartridges 10” (250 mm) height.
EPM.F Filter Cartridges ordering information
|
EPM.F |
045 |
D1 |
250 |
М |
|---|---|---|---|---|
|
Grade |
Micron rating |
Adapter code |
Nominal height |
Application |
|
|
0,65+0,45 0,85+0,45 μm 0,8 μm |
D, D1, А1, А4 |
100 = 100 mm |
M – medical and biopharmaceutical industry P – food industry E – microelectronics industry |