EPM.PS filter elements are produced on the basis of the one-layer hydrophilic asymmetric polyethersulphone membrane with the micron ratings of 0.2, 0.45 and 0.8 μm. The special pore structure ensures uniform clogging of the membrane and makes it much easier to filter viscous liquids. Increased overall porosity of the membrane combined with high thermal and chemical resistance ensures high flow rate and reliable removal of mechanical particles, bacteria, suspended matters and colloids from liquids in a wide range of pH.
Extremely low absorption of the polyethersulphone membrane makes EPM.PS the best choice for application in the processes of filtration of protein-containing solutions and biological liquids, especially in biopharmaceutical industry and beverages industry.
| Features | Advantages |
|---|---|
|
Polyethersulfone (PES) membrane |
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Asymmetric pore structure and increased overall porosity of the membrane. |
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High strength of the structure of the cartridge |
|
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Large filtration surface area (pleated) |
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100% control |
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Non-toxic, apyrogenic |
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Main applications
In medicine and biopharmaceutics
- Fine clarifying filtration of parenteral preparations (LVP) with high or low pH.
- Fine clarifying filtration of highly viscous media, including ophthalmic solutions.
- Filtration of blood preparations, serums, injectable preparations containing protein.
- Clarification of large volumes of aqueous, pharmaceutical and biological solutions containing a large number of colloidal particles.
- Concentrating of solutions containing proteins.
- Buffer of buffer solutions.
- Filtration of galenic preparations.
- Filtration of process water (washing machines, filtration at points of consumption, non-pyrogenic water for injection, laboratory water purification, recycling water).
In beverage industry
- Biological filtration of wine in cold filling conditions.
- Cold sterilization of beer.
- Finishing (control) filtration of wines in conditions of "heat" bottling.
- Polishing filtration of vodkas, cognacs, color LVI.
- Finishing filtration of mineral waters, low-alcohol and non-alcoholic beverages.
- Sterile bottling of still water, low alcohol and non-alcoholic drinks.
- Microbiological stabilization of still bottled water.
- Fine filtration of rinsing water.
In other industries for fine purification of liquid media from particles with size of 0.2 µm or more.
Cartridge materials
|
Membrane |
Polyethersulphone (PES), asymmetric |
|
Draining layer |
Polypropylene |
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Body, end parts, adapter |
Polypropylene |
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Supporting (encapsulated) adapter ring |
Stainless steel (on request) |
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O-rings |
Silicone (other materials on request) |
Specifications
| Pore size, μm | Ordering code |
|---|---|
|
0,20 |
020 |
|
0,45 |
045 |
|
0,65 |
065 |
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 |
Integrity test values of EPM.PS
| Grade | Max. diffusion, ml/min | Test pressure, MPa (kgf/cm2) |
|---|---|---|
|
EPM.PS-020 |
30 |
0,17 (1,7) at 20°С |
|
EPM.PS-045 |
30 |
0,14 (1,4) at 20°С |
|
EPM.PS-065 |
30 |
0,10 (1,0) 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.
Operational parameters
|
Maximal differential pressure, MPa |
0,5 MPa at 20°C, 0,2 MPa at 80°C |
|
Maximal reverse differential pressure, MPa |
0,2 MPa at 20°C |
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Maximal operational temperature, °C |
90°С |
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Direct flow wash out |
Hot water (up to 95 °C) and chemical agents |
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Autoclaving |
121°С, 0.11 MPa, 30 min., 50 cycles 132°С, 0.2 MPa, 30 min., 30 cycles 121°С, 0.12 MPa, 30 min., 25 cycles |
|
Steam sterilization |
до 135°С, 0.2 MPa, 30 min., 30 cycles |
* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter RME.
EPM.PS 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.PS 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.PS 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 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
In the course of testing each membrane-based filter element is integrity tested by the non-destructive physical method of determination of rate of air passing through the water wetted membrane.
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.PS Filter Cartridges ordering information
| EPM.PS | 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 |