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EMPK filter elements for sterilizing filtration of pharmaceutical grade fluids

Home - Products - Filter cartridges - Filter cartridges - Membrane filter elements cartridge type (cartridges) - Filtering elements mark EPM . For sterilizing filtration of liquids pharmaceutical grade

 

 

Description  

 

 

    

 

Membrane filter elements based on polyamide EPM.K 0.2 μm and 0.45 μm for clarifying and sterilizing filtration of pharmaceutical grade liquids. Membrane filters EPMK are manufactured using the patented technology of the Technofilter, based on a two-layer hydrophilic membrane made of polyamide with a pore size of 0.2 and 0.45 microns. Filter elements have high throughput and good chemical resistance to organic solvents and alkalis. 

 

 

 

 

 

Features

Advantages

The patented hydrophilic membrane made of polyamide Nylon6+66

  • High rates of resource and the rate of filtration with  low pressure drop
     • Broad chemical compatibility
     • Easily wetted for reliable testing for integrity

Reliable proven membrane characteristics 0.2 MKM

  • Comply with the requirements of the medical industry manufacturers association on microbiological screening filters 0.2 Micron for sterilizing filtration of liquids.
  • Confirmation of sterilizing ability test results integrity.

High strength design of filter element

  • Secure the preservation of the integrity of the filter in harsh environments
    • Withstand steam sterilization.

100% control

• Guarantee the integrity and efficient operation of the product
• Provide a full apprehension of bacteria , bacteriophages and particles in liquid filtration processes-flux Wednesday

Non-pyrogenic

• Have passed the necessary tests on biological safety , extractables , allocation of pyrogens and fibers
• Have the necessary certificates of quality.

 

 

 

Filtropatrona materials

The main membrane

Nylon6+66

Pres - membrane filter

Nylon6+66

 Drainage layer

Polypropylene

Chassis , Terminal details , adapter

 Polypropylene

Firming (encapsulated) adapter ring

 Stainless steel

 Standard o-rings

Silicone (other on request)

 
  )

Main specifications

Pore size , MCM   

 order code

0,20+0,20

020/020

0,45+0,20

045/020

0,8+0,45

080/045

Geometric characteristics

Cartridge filter elements

Height (L), mm

Diameter (D) mm

Filtering Surface Area (S), m 2

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 Surface Area (S), m 2

250 (10")

94

0.75

125 (5")

94

0,34

60 (2,5")

94

0.14

The main application

  • In medicine and Biopharmacy for lightening and sterilization Parenteral and ophthalmic solutions , antibiotics , cultural , bacterial and enzymatic Wednesday , Biologics and vaccines , vitamin and herbal drugs , buffer solutions , water for pharmaceutical use (water for injection, pyrogen-free water, water for rinsing, whitewater, etc. p.).

·  In other industries for sterilizing , Finish , thin and obesplozhivajushhej filtration of aqueous  solutions , liquid Wednesday with pH 3 - 14, alkaline solutions. 

Settings exploitation

Maximum pressure drop for cartridges , Mpa

0.5 when 20° c 0.2 when 80° c

Maximum pressure drop for capsules , Mpa

0.4 when 20° With , 0.2 when 60° With

Maximum reverse differential pressure , Mpa

0.1 when 20° c

Maximum operating temperature , ° With

80° With (patrons), 60° With (capsules)

 Washing in or co-current

Hot water (up to 80° c) and chemical agents (pH 3-14).

 Sterilization

autoclaving. , ferry lines

* For detailed instructions on flushing and sterilization filtropatronov and capsules to contact technical specialists LLC " Technofilter". 

Quality and safety

 

 

Membrane cartridge Elements mark EPM . K shall be made in accordance with the regulatory - technical documents on product quality and certified for use in filtration processes biopharmaceutical solutions . All EPM .K pass ' from organic and high-purity water and mechanical impurities are subjected to 100% integrity control.  

Cleaning , control , drying , Final Assembly and packaging of membrane filter elements is carried out in special clean areas (purity class 5, 6 and 7) according to the classification of cleanrooms in the pharmaceutical industry in accordance with the EU GGMP (Presidency of the European Union on good practice - Good Manufacturing Practice).  

Membrane filter elements EPM . K undergo tests for bacterial and toxicological safety , materials , used in the construction of filters , have a minimal amount of extractable components and approved for contact with intravenous drugs and food . Safety filter installed a series of sanitary - chemical and toxicity tests , conducted according to GOST r ISO 10993.1 - 99, GOST R ISO 10993.5 - 99, GOST R ISO 10993.10 - 0000 " Compendium of guiding teaching materials of toxicological - hygienic study of polymer materials and products on their basis for medical purposes ", THE MINISTRY OF HEALTH OF THE USSR . 1987 g  

 

 

The integrity test


If production tests every product is tested on the integrity of the non-physical method to determine the rate of flow of gas through the water-soaked membrane . The speed of diffusion for EPM . To - 020 does not exceed 15 ml / min pressure 0.25 Mpa . This diffusion threshold provides 100% retention of bacteria Brevundimonas Diminuta concentration t R > 107 SOME / see 2.

Performance test values testing EPM . To the integrity of using automated control systems

Mark

maximum value of diffusion (D), ml / min. 

Test pressure , Mpa (kgf/cm2)

EPM.К-/020

≤15

0,25 (2,5) when 20°С

EPM.К-/045

≤15

0,16 (1,6) when 20°С

* All values are given for the height element 10 "(250 mm). Maximum permissible values of diffusion for standard cartridges 10 " should be multiplied by 2 for cartridges 20 "(500mm) and on the 3 for cartridges 30 "(750mm) . 

 

Sterilising test ability


Confirmed ability to mark items EPM sterilization . To - 020/020 and EPM . K - 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 . K 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.

 Ordering information recommended the EPM.K

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 

 

Sterilising test ability

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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