Membrane-based filter elements EPM.K (0.2 and 0.45 μm)

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Filter cartridge
Washed with ultra pure water
Bacterial safety testing
Produced in clean room conditions according to GMP
Pyrogene-free, tested for toxicological safety
Sterilizing filter Quality Certificate
Filter capsule
Tested for integrity
Produced according to ISO 9001:2015
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Filter cartridge
Washed with ultra pure water
Bacterial safety testing
Produced in clean room conditions according to GMP
Pyrogene-free, tested for toxicological safety
Sterilizing filter Quality Certificate
Filter capsule
Tested for integrity
Produced according to ISO 9001:2015
Show more

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.

Features and applications
Order information
Features and applications



Proprietary polyamide hydrophilic membrane Nylon6+66

  • High lifetime and filtration rates at low differential pressure; 
  • Wide chemical compatibility; 
  • Easy to wet to perform the filtration and tests.

Reliable checked characteristics of the 0.2 μm membrane

  • Comply with the requirements of the directive of the Association of Manufacturers of Medical Industry on microbiological examination of 0.2 μm filters for sterilizing filtration of liquids;
  • Confirmation of sterilization capability on the basis of the integrity test results.

High strength of the structure of the cartridge

  • Reliable maintenance of filter integrity under heavy duty operational conditions;
  • Able to withstand steam sterilization.

100% control 

  • Guaranteed integrity and efficient operation of the product;
  • Provide full retention of bacteria, bacteriophages and particles in high flow rate processes of liquids filtration;


  • Passed all necessary tests for biological safety, extractability, pyrogene and fiber emission;
  • Provided with necessary quality certificates.

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



Prefilter membrane


Draining layer


Body, end parts, adapter


Supporting (encapsulated) adapter ring

Stainless steel


Silicone (other materials available)


Pore size, μm

Ordering code







Nominal Dimensions and Filter Areas

Height (H), mm 

Diameter (D), mm 

Filter surface area (S), m2

100 (4") 



250 (10") 



500 (20") 



750 (30") 



1000 (40") 



Operational parameters

Maximal differential pressure

0.5 MPa at 20°C, 0.2 MPa at 80°C 

Maximal reverse differential pressure

0.1 MPa at 20 °C

Maximal operational temperature


Direct flow wash out

Hot water (up to 80 °C) and chemical agents

Steam sterilization

121 °С, 0.12 MPa, 30 min, 10 cycles


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


Max. Diffusion D, ml/min

Test pressure, MPa (kgf/cm2)



0,25 (2,5) at 20°С



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.

Order information

EPM.K Filter Cartridges ordering information







Micron rating

Adapter code

Nominal height



020/020 = 0,2+0,2 μm
045/020 = 0,45+0,2 μm
065/045 = 0,65+0,45 μm

D, D1, A1, A4

100 = 100 mm
125 = 125 mm
250 = 250 mm (10")
500 = 500 mm (20")
750 = 750 mm (30")
1000=1000 mm (40")

М = medical and biopharmaceutical industry