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Membrane filters made of polyethersulfone EPM.PС 0.2 μm and 0.45 μm for sterilizing filtration of pharmaceutical grade fluids

Home - Products - Filter cartridges - Filter cartridges - Membrane filter elements cartridge type (cartridges) - Membrane filters made of polyethersulfone EPM.PС 0.2 μm and 0.45 μm for sterilizing filtration of pharmaceutical grade fluids

 

Description

Membrane filters EHMPS are produced on the basis of a hydrophilic membrane of polyethersulfone with a pore size of 0.2 and 0.45 microns. The pronounced asymmetric structure of the pores and the increased total porosity of the membrane ensure that the EPMMS has high flow rates with a minimum differential pressure. High thermochemical resistance combined with low sorption in relation to proteins, proteins and enzymes makes EPMP essential for the critical filtration of biological solutions, blood products, serums, ophthalmic liquids, vaccines and other liquid media with high or low pH.

The features and benefits

CHARACTERISTICS

ADVANTAGES FOR THE USER

Hydrophilic asymmetric polyethersulfone membrane (PES).

  • The best combination of high resource productivity and low pressure drop provides cost-effective, efficient filtration.
  •  Low adsorption of protein.
  •  Increased thermochemical resistance provides the possibility of multiple sterilization or washing at elevated temperatures in a wide range of reagents.
  •  Easy wetted in the processes of filtration and testing.

Reliable and proven characteristics of the 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.
  •  Ensure the complete arrest of the bacteria, bacteriophages and particles in high-flow filtration of liquid media.

High strength filter element

  • Reliable preservation of the integrity of the filter in harsh environments.
  •  Can withstand repeated steam sterilization.

100% inspection for integrity

  • Guarantee the integrity and efficient operation of the device.

Main applications


In medicine and biopharmaceutics

  • Fine and sterilizing filtration of parenteral preparations (LVP) high or low pH.

• Fine and sterilizing filtration of highly viscous media, including ophthalmological solutions.

• Filtration of blood preparations, serums, injectable preparations containing the protein.

• Clarification and sterilization of large volume aqueous, pharmaceutical and biological solutions containing large amounts of colloid particles.

• Concentrating protein-containing solutions.

• Filtering of the buffer media.

• Herbal production.

• Filtration of process water (washing machines, filtration at points of consumption, non-pyrogenic water for injection, laboratory water purification, recycling water)

In other branches of industry for fine purification of liquid media from a particle size of 0.2 µm or more.

Materials filterpatrone

The main membrane Polyethersulfone (PES) asymmetric

The main membrane Polyethersulfone (PES) asymmetric

Pre-filter membrane Polyethersulfone (PES) asymmetric

Pre-filter membrane Polyethersulfone (PES) asymmetric

Drainage layer Polypropylene

Drainage layer Polypropylene

Housing, end parts, adapter, Polypropylene

Housing, end parts, adapter, Polypropylene

Strengthening (encapsulated) ring adapter Stainless steel

Strengthening (encapsulated) ring adapter Stainless steel

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

0,20+0,20 020/020

0,45+0,20 045/020

0,45+0,20 045/020

0,8+0,45 080/045

0,8+0,45 080/045

Geometric characteristics

Cartridge filter elements

Height (L) mm

Diameter (D) mm

filtering 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

filtering Area (S), m2

250 (10")

94

0.7

125 (5")

94

0.33

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

0.2 at 20°C, 0.05 at 80°C (cartridges)

The maximum temperature of operation, °C

90°C (cartridges), 60°C (capsules)

Flushing in the forward flow

Hot water (95°C) and chemical (pH 1-14).

Autoclaving

121°C, 0.11 MPa, 30 min, 80 cycles (rounds)

The sterilization (only cartridges)

132°C, 0.2 MPa, 30 min., 20 cycles (rounds)

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

Quality and Safety


Elements of cartridge  EPM.PS are produced in accordance with regulatory and technical documents for product quality and certified for use in filtration processes of biopharmaceutical solutions. All EPMMs pass through washing from organic and mechanical contamination 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 filtering elements EPMPS are subjected to tests 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, each product is tested for integrity by a non-destructive physical method to determine the flow rate of gas through a water-wet membrane. The diffusion rate for EPM-PC-020 does not exceed 20 ml / min at a pressure of 0.25 MPa. This diffusion threshold provides 100% retention of the Brevundimonas Diminuta bacteria at a concentration of TR> 107 cfu / cm2.

Indicators of test values during testing of EPMM for integrity with the use of automatic control systems


Mark

The maximum value of the diffusion D, 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 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) .

The test for a sterilizing ability


The sterilizing ability of the elements of EPM.PС-020/020 and EPM.PS-045/020 with respect to the Brevundimonas Diminuta test microorganism, strain PCI 818 (Pseudomonas Diminuta ATCC 19146, DSM 1635) was confirmed. The level of microbiological load on the filter element meets the requirements of the directive of the Association of Manufacturers of the Medical Industry for microbiological examination of filters for sterilization of liquids. EPMMC were tested for bacterial retention after 10 cycles of autoclaving at T = 121 ° C in the pharmacopoeial regime.

The tests were carried out by passing a bacterial suspension of Brevundimonas Diminuta in the amount of 10 11-12 CFU / cm2 through the filter element, followed by inoculating the filtrate into the liquid nutrient medium (MU 42-51-17-93), which ensures the passage of bacteria through the membrane with a pore size of 0.45 m. The tests were carried out while observing the requirements for aseptic production of medical products GOST R ISO 13408-2-2007 (Part 2, filtration).

 

Bacterial endotoxin (pyrogenicity)


The filtrate samples were tested for bacterial endotoxin (BE) with the LAL test. The content of BE is less than -0.01 EE / ml, the allowable value for water for the preparation of injection solutions is less than 0.03 EE / ml.

Ordering information  recommended the EPM.PS

EPM.PS

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

080/045=0,8+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 FMC.PS

EPM.PS

045/020

К

125

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

 080/045=0,8+0.45 µm

К-санитарное фланцевое

60 mm

 125 mm

250 mm


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