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Membrane filters EPM.K + on the basis of polyamide membrane with Zeta-potential for sterilizing filtration with control of pyrogenicity, removal of viruses from aqueous systems of the pharmaceutical class

Home - Products - Filter cartridges - Filter cartridges - Membrane filter elements cartridge type (cartridges) - Membrane filters of EPM.K+, based on the polyamide membrane with the Zeta-potential for the sterile filtration with the control of apirogennost, remove viruses from water systems of pharmaceutics class

 

 

 

Description


Membrane filter element of EPM.K + brand based on a patented modified-charge polyamide membrane (Z-potential) for the removal of endotoxins and viruses from aqueous pharmaceutical grade systems. The positively charged surface of the filter membrane allows to retain not only particles and microorganisms, but also bacterial endotoxins (pyrogens), viruses and molecules that are not retained by a conventional sterilizing microfilter.

Main applications


  • Filtration of injection and infusion solutions with control of pyrogenicity.

  • Sterilizing filtration of low-seeded solutions.

  • For the removal of mycoplasmas, bacterial endotoxins (pyrogens) and viruses from aqueous solutions.

  • Continuous sterile filtration in water treatment systems.

  • Final stages of production of deionized water / water for injection.


Features

Advantages

Patented hydrophilic membrane charge modified polyamide (Nylon6+66).

  • Reliable sterilizing filtration with the control of progenote.
  •  Effective removal of negatively charged viruses, molecules, endotoxins, bacteria, particles and biogarantie.
  •  Wide chemical compatibility.
  •  Easily wetted during the filtration and testing.

Reliable proven features 0.2 µm membrane.

  • Meet the requirements of the Directive of the Association of producers of medical industry on microbiological examination of filters 0.2 µm for sterile filtration of liquids.
  • • Confirmation of sterilization abilities according to the results of the integrity testing.

High-strength construction filter element.

  • Reliable preservation of the integrity of the filter in harsh environments.
  •  Can withstand repeated steam sterilisation and washing.

100% inspection for integrity.

  • Guarantee the integrity and efficient operation of the device.
  •  Ensure the complete arrest of the bacteria, bacteriophages and particles in high-flow filtration of liquid media.

Non-pyrogenic. Developed and adapted for the pharmaceutical and biotechnology industries.

  • Passed the necessary tests for biological safety, ekstragiruyut, the release of pyrogens and fibers.
  •  Have the necessary quality certificates.

 

Materials filterpatrone

The main membrane Nylon6+66 Z-potential

The main membrane Nylon6+66 Z-potential

Pre-filter membrane Nylon6+66 Z-potential

Pre-filter membrane Nylon6+66 Z-potential

Drainage layer Polypropylene

Drainage layer Polypropylene

Housing, end parts, adapter, Polypropylene

Housing, end parts, adapter, Polypropylene

Strengthening (encapsulated) ring adapter Stainless steel (on request)

Strengthening (encapsulated) ring adapter Stainless steel (on request)

Standard o-rings Silicone (others on request)

Standard o-rings Silicone (others on request)

Key specification

Pore size, mkm

Code for ordering

0,20+0,20

020/020

0,45+0,20

045/020

0,45

045

Geometric characteristics

Cartridge filter elements

Height (L) mm

Diameter (D) mm

filtering Area (S), m2

100 (4")

70

0.27

250 (10")

70

0.75

500 (20")

70

1.5

750 (30")

70

2.25

1000 (40")

70

3.0

 

Capsule filters

Height (L) mm

Diameter (D) mm

filtering Area (S), m2

250 (10")

94

0.75

125 (5")

94

0.34

60 (2,5")

94

0.14

The operating parameters

Maximum differential pressure for cartridges, MPa

0.5 at 20°C and 0.2 at 80°C

Maximum differential pressure for capsules, MPa

0,4 at 20°C 0.2 at 60°C

Maximum reverse pressure differential, MPa

Of 0.1 at 20°C

The maximum temperature of operation, °C

80°C (cartridges), 60°C (capsules)

Flushing in the forward flow

Hot water (80°C) and chemical (pH 3-14).

Autoclaving

121°C, 0.11 MPa, 30 min., 20 cycles (rounds)

The sterilization (only cartridges)

121°C, 0.11 MPa, 30 min., 5 cycles (capsule)

* For detailed instructions on cleaning and sterilization and capsules recommended refer to the technical specialists of NPP "Technofilter".

Quality and Safety


Elements cartridge cartridge grade EPM.K + are manufactured in accordance with regulatory and technical documents for product quality and certified for use in filtration processes of biopharmaceutical solutions. All EPMK + are washed from organic and mechanical impurities with highly purified water and are subjected to 100% integrity control.

Washing, monitoring, drying, final assembly and packaging of membrane filter elements is carried out in special clean zones (Cleanliness class 5, 6 and 7) according to the classification of clean rooms in the pharmaceutical industry in accordance with EU GGMP (Good Manufacturing Practice of the European Union Practice).

Membrane filter elements are tested for bacterial and toxicological safety, materials used in the design of filters, have a minimum amount of extracted components and are allowed to contact with intravenous drugs and food. The safety of filter elements is established by a series of sanitary-chemical and toxic tests conducted in accordance with GOST R ISO 10993.1-99, GOST R ISO 10993.5-99, GOST R ISO 10993.10-00, "Collection of guidelines for toxicological and hygienic research of polymeric materials and products on their basis of medical designation ", Ministry of Health of the USSR. 1987

 

The integrity test


During production tests every product is checked for integrity non-destructive physical method of determining the flow rate of gas through the water-wetted membrane. The rate of diffusion for the EPM.To+-020 less than 15 ml/min at a pressure of 0.25 MPa. This threshold value diffusion provides 100% retention of Brevundimonas Diminuta bacteria at a concentration TR >107 CFU/cm2.


Indicators of test values in the test of EPM.K+ for integrity using automatic control systems


Mark

The maximum value of diffusion ml/min

Test pressure, MPa (bar)

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 for elements with a height of 10"(250 mm). The maximum permissible diffusion value for standard cartridges 10" should be multiplied by 2 for cartridges 20"(500mm) and 3 for cartridges 30"(750 mm) .

Bacterial endotoxin (pyrogenicity)

Samples of the filtrate is tested for bacterial endotoxin (EB) using the LAL test. The contents BAE - less -0,01 EC/ml, an accepted value for water used to prepare injection solutions less than 0.03 UM/ml.

Ordering information  recommended the EPM.K+

EPM.K+

045/020

Д1

250

М

Mark

Micron rating

 

nominal length

application

 

020/020 = 0,2+0,2 µm

045/020=0,45+0,2 µm

045=0.45 µm

Д, Д1, А1, А4

100 = 100 mm

125 = 125 mm

250 = 250mm (10")

500 = 500mm (20")

750 = 750mm (30")

1000=1000mm(40")

M = medicine and Biopharmaceuticals. 

Order information capsules KFM.K+

KFM.K+

045/020

К

60

Mark

Micron rating

Connection type

The height of the filter element

 

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

045=0.45 µm

K-sanitary flange

R-threaded conical (for height 60mm)

60 mm

125 mm 2

50 mm


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