KFM.PS Capsules (0.2 and 0.45 μm) are produced on the basis of hydrophilic PES membrane with a pore size 0.2 and 0.45 μm.
Designation
KFM.PS Capsules (0.2 and 0.45 μm) are used for preliminary, fine, polishing and sterilizing filtration of liquid media in various industries from mechanical impurities and microorganisms with the size above or equal 0.2, 0.45, 0.65 μm.
Main applications
In medicine and biopharmaceutics:
- Fine and sterilizing filtration of parenteral preparations (LVP) with high or low pH.
- Fine and sterilizing filtration of highly viscous media, including ophthalmological solutions.
- Filtration of blood preparations, serums, injectable preparations containing protein
- Polishing and sterilization of big volumes of water based, pharmaceutical and biological solutions, containing a large number of colloidal particles. for concentrating of solutions containing proteins.
- Concentration of protein containing solutions.
- Filtration of buffer media.
- Filtration of galenic preparatios
- 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 a size of 0.2 microns and more.
Capsule materials
|
Membrane |
Polyethersulfone |
|
Draining layer |
Polypropylene |
|
Capsule body, inner and outer bodies, tip covers, fittings |
Polypropylene |
KFM.PS main combinations of pore sizes
|
Pore size, μm |
Ordering code |
|---|---|
|
0,20+0,20 |
020/020 |
|
0,45+0,20 |
045/020 |
|
0,65+0,45 |
065/045 |
Operational parameters
|
Mean membrane pore size, μm |
0,2 |
0,45 |
0,65 |
|
|
Minimal bubble point, MPa |
0,33 |
0,25 |
0,17 |
|
|
Initial water flow rates (for distilled water) at t=20°С, Р=0,05 МPа for filter cartridge 60 mm height для, dm3/h |
400 |
700 |
900 |
|
|
Maximal operational pressure, MPa |
0,4 |
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|
Maximal differential pressure for capsules, MPa |
0,4 at 20°С; 0,1 at 60°С |
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|
Maximal operational temperature, °C |
60 |
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|
Effective filter area for filter cartridge 60 mm height (single layer/double layer), m2 |
0,175-double layer |
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|
Recommended change-out differential pressure, MPA (bar) |
0,24 (2,4) |
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|
Number of sterilization cycles (autoclaving) at P=0,1 MPa и t=126 ±1°C for 45 min., at least |
10* |
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Sanitization and sterilization
Sterilization of Capsules is performed by autoclaving at temperature 126°С for 45 minutes after attainment of set-point temperature.
KFM.PS Capsules are able to withstand at least 10 sterilization cycles by autoclaving at P = 0,1 MPa and t=126 ± 1°С. Note! It is prohibited to sterilize Capsule by steam-in-line!
* It is necessary to perform integrity testing of Capsules after every autoclaving cycle in case of sterilizing filtration and re-using. The integrity testing can be performed using automatic integrity test devices, for example TECHNOCHECK series.
KFM.PS Capsules withstand chemical sterilization with 3% of hydrogen peroxide solution or 10% chloramine solution and hot water flushing up to 90°С. The possibility of flushing and repeated autoclaving allows reuse of Capsules till the end of its life time.
KFM.PS Capsules are compatible with a wide variety of chemical substances.
Nominal dimensions
|
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
|---|---|---|
|
1000 (40") |
88 |
2.8 |
|
750 (30") |
88 |
2.1 |
|
500 (20") |
88 |
1.4 |
|
250 (10") |
88 |
0.7 |
|
125 (5") |
88 |
0.33 |
|
60 (2,5") |
88 |
0.14 |
For detailed instructions on operation Capsules please contact technical specialists of Technofilter RME.
Quality and Certitication
All membrane filter elements used for production of KFM.PS Capsules are subjected to wash out from organic and mechanical impurities with high-purity water and to 100% integrity control.
KFM.PS Capsules are added to the Register of Medical Devices of the Ministry of health of the Russian Federation.
The Capsules are certified for use in Medical Industry and Sanitary and Epidemiological Station, they are authorized to use in Food industry. Safety of filter elements 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.
KFM.PS Capsules ordering information
|
KFM.PS |
045/020 |
К |
125 |
|---|---|---|---|
|
Grade |
Micron rating |
Connection type |
Capsule height |
|
020/020 = 0,2+0,2 μm |
K – sanitary clamp P – thread cone-shaped |
60 = 60 mm (2,5") |