The filter elements on the base of polyamide membrane EPM.K 0.2 μm and 0.45 μm for clarifying and sterilizing filtration of pharmaceutical preparations.
EPM.K membrane filters are produced by the proprietary technology of Technofilter on the basis of two layers of hydrophilic polyamide membrane with the micron rating of 0.2 μm and 0.45 μm. Filter elements have high throughput and high chemical resistance to organic solvents and alkali.
A polyamide hydrophilic membrane makes EPM.K the best option for application in the processes of large volume filtration of parenteral preparations, antibiotics, water and alkaline solutions.
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Features |
Advantages |
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Proprietary polyamide hydrophilic membrane Nylon6+66 |
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Reliable checked characteristics of the 0.2 μm membrane |
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High strength of the structure of the cartridge |
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100% control |
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Apyrogenic |
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Main Applications
- In medicine and biopharmaceuticals for clarification and sterilization of parenteral and ophthalmic solutions, antibiotics, cultural, bacterial and fermentative media, biological products and vaccines, vitamin and herbal preparations, buffer solutions, water for pharmaceutical use (water for injection, pyrogen-free water, water for rinsing, circulating water, etc.).
- In other industries for sterilizing, finishing, fine and de-supportive filtration of aqueous solutions, liquid media with pH 3-14, alkaline solutions.
Cartridge materials
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Membrane |
Nylon6+66 |
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Prefilter membrane |
Nylon6+66 |
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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 (other materials available) |
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 and Filter Areas
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Height (H), mm |
Diameter (D), mm |
Filter surface 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 |
0.5 MPa at 20°C, 0.2 MPa at 80°C |
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Maximal reverse differential pressure |
0.1 MPa at 20 °C |
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Maximal operational temperature |
80°С |
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Direct flow wash out |
Hot water (up to 80 °C) and chemical agents |
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Steam sterilization |
121 °С, 0.12 MPa, 30 min, 10 cycles |
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Autoclaving |
121 °С, 0.12 MPa, 30 min, 20 cycles |
* For detailed instructions on washing out and sterilizing of filter cartridges, please contact technical specialists of Technofilter RME, LLC.
EPM.K membrane-based filter cartridges 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 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.
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 element 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.K
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Grade |
Max. Diffusion D, 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 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.
Sterilization test (Bacterial challenge test)
The bacteria removal test is carried out for each series of 0.2 µm sterilizing filter elements by passing a bacterial suspension of Brevundimonas Diminuta through the filter elements in an amount of 107 CFU / cm2. Confirmed test results correlate with integrity test. *
* According to GOST R ISO 13408-2-2007 Aseptic production of medical products. Part 2. Filtration.
Bacterial endotoxins (pyrogenicity)
Filtrate samples are tested for bacterial endotoxin (BE) content using the LAL test. The BE content is less than - 0.05 EU / ml, the permissible value for water for the preparation of injection solutions is less than 0.25 EU / ml.
EPM.K Filter Cartridges ordering information
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EPM.K |
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+0,2 μm |
D, D1, A1, A4 |
100 = 100 mm |
М = medical and biopharmaceutical industry |