EPM.SK filter elements are based on polyamide membrane and fiberglass for effective clarifying filtration of liquids with a high concentration of particles and microorganisms in various fields of application.
EPM.SK is a composite membrane element that combines mechanisms of depth and membrane filtration. The basis of EPM.SK is the polyamide hydrophilic membrane combined with a microfiber depth prefilter. EPM.SK is developed for application in the processes that require significant reducing of contamination and bioburden, providing high performance and reliable removal of particles and microorganisms of the specified size. EPM.SK filters have high flow rate, increased contamination capability and wide chemical compatibility.
Main applications
- In medicine and biopharmacy for treatment from mechanical impurities and clarifying of parenteral and ophthalmic solutions, antibiotics, culture, bacterial and enzymatic media, biologics and vaccines, vitamin and galenic preparations, buffer solutions, water for pharmaceutical use (water for injection, pyrogen-free water, water for rinsing, etc.).
- In beverage industry for polishing filtration of non-alcoholic beer, wine, premium class liqueurs and spirits, for microbiological treatment of still bottled water, for final filtration of alcoholic-free and low-alcoholic beverages, for filtration of reagents, water preparations.
- In other industries for fine filtration of liquid media from particles sized 0.8 – 1 μm and more.
Cartridge materials
|
Membrane |
Nylon6+66 |
|
Draining layer |
Fiberglass |
|
Body, end parts, adapter |
Polypropylene |
|
O-rings |
Silicon (others on request) |
Nominal Dimensions
|
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
|---|---|---|
|
125 (5") |
70 |
0.25 |
|
250 (10") |
70 |
0.5 |
|
500 (20") |
70 |
1.0 |
|
750 (30") |
70 |
1.5 |
|
1000 (40") |
70 |
2.0 |
Pore size
|
Pore size, μm |
Ordering code |
|---|---|
|
3,0+1,0 |
300/100 |
|
3,0+0,65 |
300/065 |
|
3,0+0,8 |
300/080 |
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 |
|
Maximal operational temperature, °C |
80°С |
|
Direct flow wash out |
Hot water (up to 80°C) and chemical agents (pH 3-14) |
|
Autoclaving |
121°С, 0.12 MPa, 30 min., 10 cycles |
|
Steam sterilization |
121°С, 0.12 MPa, 30 min., 20 cycles (cartridge) |
* 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 elements 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 of membrane filter cartridges is carried out in special clean rooms C and D (ISO class 5, 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.
Integrity test
In the course of testing each membrane filter cartridge is integrity tested by the non-destructive physical method of determination of rate of air passing through the water wetted membrane.
Integrity test values of EPM.SK
|
Grade |
Max. diffusion, ml/min |
Test pressure, MPa (kgf/cm2) |
|---|---|---|
|
EPM.SK-/065 |
30 |
0,11 (1,1) at 20°С |
|
EPM.SK-/080 |
30 |
0,08 (0,8) at 20°С |
|
EPM.SK-/100 |
30 |
0,06 (0,6) at 20°С |
Bacterial endotoxins (pyrogenicity)
Filtrate samples are examined for bacterial endotoxin (BE) content using the LAL test. BE content – 0.05 EU/ml, the allowable value for water intended for preparation of injection solutions is less than 0.25 EU/ml.
EPM.SK Filter Cartridges ordering information
|
EPM.SK |
300/100 |
D1 |
500 |
М |
|---|---|---|---|---|
|
Grade |
Micron rating |
Adapter code |
Nominal height |
Application |
|
|
065 = 0,65 μm 080 = 0,8 μm 100 = 1 μm |
А (А1), А4, D (D1), В, ВSl |
100 = 100 mm 125 = 125 mm |
M – medical and biopharmaceutical industry P – food industry E – microelectronics industry |