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Filter cartridge
Ultra pure air stripping
Produced in clean room conditions according to GMP
Pyrogene-free, tested for toxicological safety
Filter capsule
Tested for integrity
Produced according to ISO 9001:2015
Show more
Filter cartridge
Ultra pure air stripping
Produced in clean room conditions according to GMP
Pyrogene-free, tested for toxicological safety
Filter capsule
Tested for integrity
Produced according to ISO 9001:2015
Show more

EPM.F4 filter elements are produced on the basis of the hydrophobic fluoroplastic (PTFE) membrane with the micron rating of 0.2 μm. The hydrophobic cartridge with absolute filtration rating is designed for sterilizing filtration of air, gases and aggressive liquids in medical, pharmaceuticals, food and other industries. EPM.F4 filter elements have high flow rate and chemical compatibility.

Features and applications
Specifications
Safety
Order information
Features and applications

Features

Advantages

Fluoroplastic (PTFE) hydrophobic sterilizing membrane.

  • The membrane is stable to clogging by wetness, it provides high indexes of rate of air and gas flow rate at low differential pressure.
  • Wide chemical compatibility (pH 1-14).
  • Excellent thermochemical resistance.
  • Ensures full retention of bacteria, bacteriophages and aerosol particles in flows of compressed air and gases.

High strength of the structure of the filter element

  • Reliable maintenance of filter integrity under heavy duty operational conditions.
  • Withstands multiple steam sterilization.
  • Guaranteed integrity after multiple sterilization cycles.

100% control

  • Control performed with the “dry” method using aerosol particles and the “wet” method – diffusion test.
  • Guaranteed integrity and efficient operation of the device.

Main applications

  • Sterile filtration of air and gases in contact with the product.
  • Systems of air supply.
  • Ventilation of containers. 
  • At the input of filling devices.
  • At the input and output of bioreactors.
  • Sterile aeration of fermenters.
  • Sterile purging of equipment.
  • For filtration of aggressive liquids (acids, alkali, solvents, non-aqueous solutions, technical fluids) in the pH range of 1-14.
Specifications

Cartridge materials

Membrane

PTFE (Fluoroplast-4)

Draining layer

Polypropylene

Body, end parts, adapter

Polypropylene

Supporting (encapsulated) adapter ring

Stainless stee (on request)

O-rings

Silicone (Viton, FPM, EPDM, PTFE on request)

Specifications

Pore size, μm

0,20

Micron rating for air and gases

‹0,02 μm

Height (H), mm 

Diameter (D), mm 

Filter surface area (S), m2 

100 (4")

70

0.35

250 (10")

70

0.9

500 (20")

70

1.8

750 (30")

70

2.7

1000 (40")

70

3.6

Operational parameters

Maximal differential pressure, MPa

0,5 MPa при 20°C, 0,2 MPa at 80°C

Maximal reverse differential pressure, MPa

0,2 MPa at 20°C, 0,05 MPa at 80°С

Maximal operational temperature, °C

90°С

Autoclaving

121-132°С, 30-45 min., 100 cycles

Steam sterilization

121°С, 0.12 MPa, 30 min., 100 cycles

135°С, 0.2 MPa, 30 min., 50 cycles

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

Safety

EPM.F4 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.F4 filter elements are subjected to purging from mechanical impurities with high-purity air and to 100% integrity control.

Final assembly and packaging of membrane filter cartridges is carried out in special clean rooms (ISO class 6 and 7) according to the classification of clean rooms in the pharmaceutical industry in accordance with EU GGMP.

EPM.F4 membrane 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 values of EPM.F4 with height 250 mm

Grade

Max. Diffusion D, ml/min

Permeability with aerosol particles (size 0.2-0.3 μm) at linear flow rate 1.0-1.7 cm3 /s·cm2*

EPM.F4-/020

20

not more than 0,0004%

EPM.F4-020

30

not more than 0,0004%

* This test fully correlates with the test for sterilization capability using the aerosol containing

Brevundimonas Diminuta bacteria with the concentration of 2х1010 CFU/cm2.

Order information

EPM.F4 Filter Cartridges ordering information

EPM.F4

020

D1

250

М

Grade

Micron rating

Adapter code

Nominal height

Application

 

020 = 0,2 μm

020/020 = 0,2 +0,2 μm

D, D1, А1, А4

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

M – medical and biopharmaceutical industry

P – food industry