EPM.FG filter elements are produced on the basis of the hydrophilized fluoroplastic membrane with the micron rating of 0.2-0.8 μm. Filter elements have high flow rate, wide chemical compatibility, low degree of protein binding.
Cartridge materials
|
Membrane |
Hydrophilic PVDF |
|
Draining layer |
Polypropylene |
|
Body, end parts, adapter |
Polypropylene |
|
O-rings |
Silicone (others on request) |
Specifications
|
Pore size, μm |
Ordering code |
|---|---|
|
0,20 |
020 |
|
0,45 |
045 |
|
0,65 |
065 |
|
0,8 |
080 |
Nominal dimensions
|
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
|---|---|---|
|
125 (5") |
70 |
0.4 |
|
250 (10") |
70 |
0.8 |
|
500 (20") |
70 |
1.6 |
|
750 (30") |
70 |
2.4 |
|
1000 (40") |
70 |
3.2 |
Operational parameters
|
Maximal differential pressure, MPa |
0,5 MPa at 20°C, 0,2 MPa at 80°C |
|
Maximal reverse differential pressure, MPa |
0,1 MPa at 20°C, 0,05 MPa at 80°С |
|
Maximal operational temperature, °C |
80°С |
|
Direct flow wash out |
Hot water (up to 95 °C) and chemical agents |
|
Autoclaving |
121°С, 0.12 MPa, 30 min., 50 cycles |
|
Steam sterilization |
up to 135°С, 30 min., 30 cycles |
* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter RME.
EPM.FG 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.FG filter elements are subjected to wash out from organic and mechanical impurities with high-purity water 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 5, 6 and 7) according to the classification of clean rooms in the pharmaceutical industry in accordance with EU GGMP.
EPM.FG membrane-based 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.FG
|
Grade |
Max. Diffusion D, ml/min |
Test pressure, MPa (kgf/cm2) |
|---|---|---|
|
EPM.FG -/020 |
20 |
0,17 (1,7) at 20°С |
|
EPM.FG -/045 |
20 |
0,14 (1,4) at 20°С |
|
EPM.FG -/065 |
20 |
0,10 (1,0) at 20°С |
|
EPM.FG -/080 |
20 |
0,08 (0,8) at 20°С |
*All values are given for the filter elements 10” (250 mm) height. To obtain maximum permissible diffusion values for filter cartridges 20” (500 mm) and 30” (750 mm) height the diffusion values for the standard (10”) cartridge should be multiplied by 2 or 3 respectively.
This diffusion threshold ensures 100% retention of Brevundimonas Diminuta bacteria at a concentration of TR> 107 CFU / cm2.
EPM.FG Filter Cartridges ordering information
|
EPM.FG |
045 |
D1 |
250 |
М |
|---|---|---|---|---|
|
Grade |
Micron rating |
Adapter code |
Nominal height |
Application |
|
|
020 = 0,2 μm |
D, D1, А1, А4 |
100 = 100 mm |
M – medical and biopharmaceutical industry P – food industry E – microelectronics industry |