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EMP.PS membrane filter cartridges (0.20 and 0.45 μm) for sterilizing filtration of pharmaceuticals

Description

EPM.PS membrane filter cartridges are produced on the basis of the hydrophilic polyethersulphone membrane with the micron ratings of 0.2 and 0.45 μm. Highly asymmetric structure and overall increased porosity of the membrane ensures high flow rate at low differential pressure for EPM.PS filter cartridges. High thermochemical resistance combined with low sorption towards proteins, albumins and ferments makes EPM.PS indispensable in critical processes of filtration of biological solutions, blood preparations, serums, ophthalmologic liquids, vaccines and other liquids with low or high pH.

 

Features

Advantages

Polyethersulfone (PES) hydrophilic asymmetric membrane.

  • Optimal ratio of high lifetime and performance at low differential pressure provides cost saving efficient filtration.
  • Low albumin sorption.
  • Increased thermochemical resistance ensures multiple sterilization and washing under high temperatures with a wide range of reagents.
  • Easy to wet to perform the filtration and tests.

Reliable checked characteristics of the 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.
  • Provide full retention of bacteria, bacteriophages and particles in high flow rate processes of liquids filtration.

High strength of the structure of the cartridge

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

100% integrity control

  • Guaranteed integrity and efficient operation of the product.

Main applications

  • In medicine and biopharmaceutics for fine and sterilizing filtration of parenteral preparations (LVP) with high or low pH, for fine and sterilizing filtration of highly viscous media, including ophthalmological solutions, for filtration of blood preparations, serums, injectable preparations containing protein, filtration of buffer solutions, for concentrating of solutions containing proteins.
  • Filtration of galenic preparations.
  • Filtration of process water (washing machines, filtration at points of consumption, non-pyrogenic water for injection, laboratory water purification, recycling water).
  • In other industries for fine purification of liquid media from particles with size of 0.2 µm or more.

Nominal Dimensions

Filter cartridges

Height (L), mm

Diameter (D), mm

Filter Area (S), m2

125 (5’’)

70

0.33

250 (10’’)

70

0.7

500 (20’’)

70

1.4

750 (30’’)

70

2.1

1000 (40’’)

70

2.8

Capsule filters

Height (L), mm

Diameter (D), mm

Filter Area (S), m2

250 (10’’)

94

0.70

125 (5’’)

94

0.33

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

0.2 MPa at 20°C

Maximal operational temperature, °C

90°C (for cartridges), 60°C (for capsules)

Direct flow wash out

Hot water (up to 95 °C) and chemical agents (pH 3-14)

Autoclaving

121°С, 0.12 MPa, 30 min., 80 cycles (cartridges)

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

132°С, 0.2 MPa, 30 min., 20 cycles (cartridges)

Steam sterilization

Up to 132°С, 0.2 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.PS 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.PS 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.PS 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.PS 

Brand

Max. diffusion, ml/min

Test pressure, MPa (kgf/cm2)

EPM.PS -/020

≤ 16

0.17 (1.7) at 20°C

EPM.PS -/045

≤ 16

0.14 (1.4) 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.  

This threshold diffusion value ensures 100 % retention of Brevundimonas Diminuta bacteria of the concentration of       ТR >107 CFU/cm2.

Sterilization capability test (Bacterial challenge test)

Bacteria removal test is performed for each series of 0.2 μm sterilizing filter cartridges by passing the bacterial suspension of Brevundimonas diminuta in the amount of 107 CFU/cm2  through the cartridge. Confirmed test results correlate with the integrity test.*

* According to GOST R ISO Aseptic processing of healthcare products. Part 2. Filtration. Sterilising test ability 

Bacterial endotoxins (pyrogenicity)

Filtrate samples are examined for bacterial endotoxin (BE) content using the LAL test. BE content – 0.05 EU/ml, the allowable value for water intended for preparation of injection solutions is less than 0.25 EU/ml.

EPM.PS Filter Cartridges ordering information

EPM.PS

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

080/045 = 0,80 + 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

 

KFM.PS Capsules ordering information

KFM.PS

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

080/045 = 0,80 + 0,45 μm

K – sanitary flange connection

P – thread tapered  connection

60 mm (4”)

125 mm (5”)

250 mm (10”)


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