EPM.K+ filter element based on positively charged (Zeta potential) polyamide membrane for removal of endotoxins and viruses from pharmaceutical class water systems. Positively charged membrane surface ensures retention of not only particles and microorganisms, but also bacterial endotoxins (pyrogenes), viruses and molecules that are not retained by a standard sterilizing microfilter.
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Features |
Advantages |
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Proprietary polyamide hydrophilic membrane with modified charge (Nylon6+66) |
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Reliable checked characteristics of the 0.2 μm membrane |
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High strength of the cartridge structure |
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100% integrity control |
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Apyrogenic. Designed and adapted for pharmaceutical and biotechnological industries. |
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Main applications
- Filtration of injections and infusion solutions with pyrogenicity control.
- Sterilizing filtration of low-seminated solutions.
- Removal of mycoplasmas, bacterial endotoxins (pyrogens) and viruses from aqueous solutions.
- Continuous sterilizing filtration in water treatment systems.
- Production of deionized water / water for injection.
Cartridge materials
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Membrane |
Nylon6+66 with positive Zeta potential |
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Prefilter membrane |
Nylon6+66 with positive Zeta potential |
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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 (on request) |
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O-rings |
Silicone (other materials are available by 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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0,45 |
045 |
Nominal Dimensions
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Height (H), mm |
Diameter (D), mm |
Filter Area (S), m2 |
|---|---|---|
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100 (4") |
70 |
0.27 |
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250 (10") |
70 |
0.75 |
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500 (20") |
70 |
1.5 |
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750 (30") |
70 |
2.25 |
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1000 (40") |
70 |
3.0 |
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 |
0,1 при 20°C |
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Maximal operational temperature, °C |
80°С |
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Direct flow wash out |
Hot water (up to 80 °C) and chemical agents |
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Autoclaving |
121°С, 0.12 MPa, 30 min., 20 cycles |
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Steam sterilization |
121°С, 0.12 MPa, 30 min., 10 cycles |
* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter.
EPM.K+ 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.K+ 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.
EPM.K+ 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
In the course of testing each membrane-based elements is integrity tested by the non-destructive physical method of determination of rate of air passing through the water wetted membrane. The diffusion rate for EPM.K+ -020 does not exceed 15 ml / min at a pressure of 0.25 MPa. This diffusion threshold ensures 100% retention of Brevundimonas Diminuta bacteria at a concentration of TR> 107 CFU / cm2.
Integrity test values of EPM.K+ when using automatic control systems
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Grade |
Max. diffusion, ml/min |
Test pressure, MPa (kgf/cm2) |
|---|---|---|
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EPM.K+-/020 |
15* |
0,25 (2,5) at 20°С |
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EPM.K+-/045 |
15 |
0,16 (1,6) at 20°С |
*All values are given for the 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.
Bacterial endotoxin (pyrogenicity)
Filtrate samples are examined for bacterial endotoxin (EU) content using the LAL test. EU content is lower than 0.05 EU/ml, the allowable value for water designated for preparation of injection solutions is less than 0.25 EU/ml.
EPM.K+ Filter Cartridges ordering information
| EPM.K+ | 045/020 | D1 | 250 | M |
|---|---|---|---|---|
| Grade | Micron rating | Adapter code | Cartridge height | Application |
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020/020 = 0,2+0,2мкм |
D, D1, А1, А4 |
100 = 100 mm |
М = medical and biopharmaceutical industry. |