EPM.PS filter elements are produced on the basis of the hydrophilic polyethersulphone membrane with the micron ratings of 0.2 and 0.45 μm. Highly asymmetric structure and overall increased porosity of the membrane ensures high flow rate at low differential pressure for EPM.PS filter elements. High thermochemical resistance combined with low sorption towards proteins, albumins and ferments makes EPM.PS indispensable in critical processes of filtration of biological solutions, blood preparations, serums, ophthalmologic liquids, vaccines and other liquids with low or high pH.
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Features |
Advantages |
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Polyethersulfone (PES) hydrophilic asymmetric membrane. |
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Reliable checked characteristics of the membrane. |
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High strength of the structure of the cartridge |
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100% integrity control |
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Main applications
In medicine and biopharmaceutics:
- Fine and sterilizing filtration of parenteral preparations (LVP) with high or low pH.
- Fine and sterilizing filtration of highly viscous media, including ophthalmological solutions.
- Filtration of blood preparations, serums, injectable preparations containing protein
- Clarification and sterilization of large volumes of aqueous, pharmaceutical and biological solutions containing a large amount of colloidal particles.
- Concentrating of solutions containing proteins.
- Filtration 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 other industries for fine purification of liquid media from particles with size of 0.2 µm or more.
Cartridge materials
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Membrane |
Polyethersulphone (PES), asymmetric |
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Prefilter Membrane |
Polyethersulphone (PES), asymmetric |
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Draining layer |
Polypropylene |
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Body, end parts, adapter |
Polypropylene |
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Supporting (encapsulated) adapter ring |
Stainless steel |
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O-rings |
Silicone (others on request) |
Specifications
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Pore size, µm |
Ordering code |
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0,20+0,20 |
020/020 |
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0,45+0,20 |
045/020 |
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0,8+0,45 |
080/045 |
Nominal Dimensions
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Height (L), mm |
Diameter (D), mm |
Filter Area (S), m2 |
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125 (5") |
70 |
0.33 |
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250 (10") |
70 |
0.7 |
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500 (20") |
70 |
1.4 |
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750 (30") |
70 |
2.1 |
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1000 (40") |
70 |
2.8 |
Operational parameters
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Maximal differential pressure, MPa |
0.5 MPa at 20°C, 0.2 MPa at 80°C |
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Maximal reverse differential pressure, MPa |
0,2 MPa at 20°C, 0,05 MPa at 80°С |
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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, 0.12 MPa, 30 min., 50 cycles 132°С, 0.2 MPa, 30 min., 30 cycles 121°С, 0.12 MPa, 30 min., 25 cycles |
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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.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-based filter elements 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 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.PS
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Grade |
Max. diffusion, ml/min |
Test pressure, MPa (kgf/cm2) |
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EPM.PS-/020 |
16* |
0,17 (1,7) at 20°С |
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EPM.PS-/045 |
16 |
0,14 (1,4) 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 threshold diffusion value ensures 100 % retention of Brevundimonas Diminuta bacteria of the concentration of ТR >107 CFU/cm2.
Sterilization capability test (Bacterial challenge test)
The sterilizing capability of EPM.PS-020/020 and EPM.PS-045/020 elements in relation to the test microorganism Brevundimonas Diminuta, strain PCI 818 (Pseudomonas Diminuta ATCC 19146, DSM 1635) was confirmed. The microbiological load on the filter element meets the requirements of the Medical Manufacturers Association directive for the microbiological examination of filters for sterilizing liquids. EPM.PS are tested for bacterial retention after 10 autoclaving cycles at T = 121 °C in pharmacopoeial mode.
The tests were carried out by passing a bacterial suspension of Brevundimonas Diminuta through a filter element in an amount of 107 CFU / cm2, followed by inoculating the filtrate into a liquid nutrient medium (MU 42-51-17-93), which ensures the passage of bacteria through a membrane with a pore size of 0.45 μm. The tests were carried out in compliance with the requirements for aseptic production of medical products GOST R ISO 13408-2-2007 (Part 2, filtration).
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
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EPM.PS |
045/020 |
D1 |
250 |
М |
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Grade |
Micron rating |
Adapter code |
Nominal height |
Application |
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020/020 = 0,2+0,2μm |
D, D1, А1, А4 |
100 = 100 mm |
M – medical and biopharmaceutical industry |