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Membrane filters EPM.K+ with Zeta-potential for sterilizing filtration, pyrogenicity control, removal of viruses from aqueous systems

Description

Membrane filter cartridge EPM.K+ 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.

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.

Features

Advantages

Proprietary polyamide hydrophilic membrane Nylon 6+66

  • Reliable sterilizing filtration with pyrogenicity control.
  • Effective removal of negatively charged viruses, molecules, endotoxins, bacteria, particles and biogarantie.
  • Wide chemical compatibility.
  • Easy to wet to perform the filtration and tests.

Large filtration surface area  (up to 0.9 m2/250 mm)

  • High lifetime and filtration rate at low differential pressure.

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 challenge 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 autoclaving and in-line steam sterilization.

100% integrity control

Apyrogenic

  • 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.

Nominal Dimensions

Filter cartridges

Height (L), mm

Diameter (D), mm

Filter Area (S), m2

100 (4’’)

70

0.36

250 (10’’)

70

0.9

500 (20’’)

70

1.8

750 (30’’)

70

2.6

1000 (40’’)

70

3.7

Capsule filters

Height (L), mm

Diameter (D), mm

Filter Area (S), m2

250 (10’’)

94

0.75

125 (5’’)

94

0.34

60 (2.5’’)

94

0.14

Operational parameters

Maximal differential pressure for cartridges, MPa

0.5 MPa at 20°C, 0.2 MPa at 80°C

Maximal differential pressure for capsules, MPa

0.4 MPa at 20°C, 0.2 MPa at 60°C

Maximal reverse differential pressure, MPa

0.1 MPa at 20°C

Maximal operational temperature, °C

80°C (for cartridges), 60°C (for capsules)

Direct flow wash out

Hot water (up to 80 °C) and chemical agents (pH 3-14)

Autoclaving

121°С, 0.12 MPa, 30 min., 20 cycles (cartridges)

121°С, 0.12 MPa, 30 min., 5 cycles (capsules)

Steam sterilization

121°С, 0.12 MPa, 30 min., 10 cycles (cartridges)

* For detailed instructions on wash out and sterilization of cartridges and capsules please contact technical specialists of Technofilter. 

Quality and safety

EPM.K+ membrane 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 cartridges 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 filter cartridges 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 filter cartridge 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+ 

Brand

Max. diffusion, ml/min

Test pressure, MPa (kgf/cm2)

EPM.K+ -/020

≤ 15

0.25 (2.5) at 20°C

EPM.K+ -/045

≤ 15

0.16 (1.6) at 20°C

*All values are given for the filter cartridges 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

Brand

Micron rating

Adapter code

Cartridge height

Application

 

020/020 = 0,2 + 0,2 μm

045/020 = 0,45 + 0,2 μm

045 = 0,45 μm

 

A (A1), A4, D (D1), B, B (Sl)

100 mm (4”)

125 mm (5”)

250 mm (10”)

500 mm (20”)

750 mm (30”)

1000 mm (40”)

M – medical and biopharmaceutical industry

F – food industry

E – microelectronics industry

KFM.K Capsules ordering information

KFM.K+

045/020

K

60

Brand

Micron rating

Connection type

Capsule height

 

020/020 = 0,2 + 0,2 μm

045/020 = 0,45 + 0,2 μm

045 = 0,45 μm

K – sanitary flange connection

P – thread tapered  connection

60 mm (4”)

125 mm (5”)

250 mm (10”)


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