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

EPM.K membrane filter cartridges are produced by the proprietary technology of Technofilter on the basis of two layers of hydrophilic polyamide membrane with the micron rating of 0.2 μm and 0.45 μm. Filter cartridges have high throughput and high chemical resistance to organic solvents and alkali. 

A polyamide hydrophilic membrane makes EPM.K the best option for application in the processes of large volume filtration of parenteral preparations, antibiotics, water and alkaline solutions.

Features

Advantages

Proprietary polyamide hydrophilic membrane Nylon 6+66

  •  High lifetime and filtration rates at low differential pressure.
  •  Wide chemical compatibility.
  • Easy to wet to perform the filtration and tests.

Reliable proven characteristics of the 0.2 μm 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.

High strength of the structure of the cartridge

  • Reliable maintenance of filter integrity under heavy duty operational conditions.
  • Able to withstand steam sterilization.

100% integrity control

  • Guaranteed integrity and efficient operation of the product.
  •  Provide full retention of bacteria, bacteriophages and particles in high flow rate processes of liquids filtration.

Apyrogenic

  • 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

0.27

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

Filter Area (S), m2

250 (10’’)

94

0.75

125 (5’’)

94

0.34

750 (30’’)

92

0.14

Main applications 

  • In medicine and biopharmacy for clarifying and sterilizing filtration of parenteral and ophthalmic solutions, antibiotics, culture, bacterial and enzymatic media, biologics and vaccines, vitamin and galenic preparations, buffer solutions, water for pharmaceutical use (water for injection, pyrogen-free water, water for rinsing, etc.).
  • In other industries for sterilizing, finish, fine and biological filtration of aqueous solutions, liquid media with pH 3-14, alkaline solutions.

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) 

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

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 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.  

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 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.K Filter Cartridges ordering information

EPM.K

045/020

D1

250

M

Brand

Micron rating,

pre-filter/membrane

Adapter code

Cartridge height

Application

 

020/020 = 0.2 + 0.2 μm

045/020 = 0.45 + 0.2 μm

080/045 = 0.8 + 0.45 μm

D, D1, A1, A4

100 mm (4”)

125 mm (5”)

250 mm (10”)

500 mm (20”)

750 mm (30”)

1000 mm (40”)

M – medical and biopharmaceutical industry

 

KFM.K Capsules ordering information

KFM.K

045/020

K

60

Brand

Micron rating,

pre-filter/membrane

Connection type

Capsule height

 

020/020 = 0.2 + 0.2 μm

045/020 = 0.45 + 0.2 μm

080/045 = 0.8 + 0.45 μm

K – sanitary flange connection

60 mm (4”)

125 mm (5”)

250 mm (10”)

Confirmed ability to mark items EPM sterilization . To - 020/020 and EPM . To - 045/020 in relation to the test - microorganism Brevundimonas Diminuta, strain PCI 818 (Pseudomonas Diminuta АТСС 19146, DSM 1635). Level of microbiological load on the filtering element corresponds to the requirements of the medical industry Manufacturers Association for microbiological examination of filters for sterilization of liquids . EPM . To tested for bacterial retention after 10 autoclave cycles at t = 121° (C) in farmakopejnom mode.

The tests were conducted by passing through the filter element to the bacterial suspension Brevundimonas Diminuta in the number of 10 11 - 12 SOME / see 2 with subsequent sowing of leachate in liquid nutrient Wednesday (MOO- 42-51-17-93) ensuring the passage of bacteria through a membrane with a pore size 0.45 MKM . The tests were conducted under sobljudeniti requirements for aseptic production of medical products to GOST r ISO 13408 - 2 - 2007 (Part 2, filtering).  

Bacterial endotoxins (pirogennost) 


Leachate Samples tested for content of bacterial endotoxin (BAE) with the help of LAL - test . Content Of BAE - less - 0.01 EU / ml , a valid value for water for cooking injecting solutions less 0.03 EU / ml.
Информация для заказа фильтропатронов ЭПМ.К

EPM.К 

045/020

Д1

250

М

Mark

 Micron rating

 

Nominal length

The application of the

 

020/020 = 0,2+0,2мкм
045/020=0,45+0,2мкм
080/045=0,8+0,45мкм

Д, Д1, А1, А4

100 = 100 мм
125 = 125 мм
250 = 250мм (10")
500 = 500мм (20")
750 = 750мм (30")
1000=1000мм(40")

M = medicine and biopharmaceuticals.

Information for ordering the CFM.C capsule.

КФМ.К

045/020

К

125

Mark

 Micron rating

Type of connection

The height of the filter element

 

020/020 = 0,2+0,2мкм
045/020=0
,45+0,2мкм
080/045=0,8+0,45мкм

К- sanitary flange

60 мм
125 мм
250 мм


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