Main applications
KFM.K+ Capsule is used in medicine and biopharmacy
- For polishing and sterilization of small and medium volumes injectables, infusion solutions, culture medium.
- For removal of bacterial endotoxins (pyrogens) from aqueous solutions.
- For finish treatment of water for injection.
- For replacing disc filters 293 mm diameter.
In other industries in ultra pure water points-of-use (removal of bacteria, endotoxins, viruses, colloids).
KFM.K+ Capsule materials
|
Membrane |
Polyamide with Zeta-potential (Nylon6 + Nylon66) |
|
Draining layer |
Polypropylene |
|
Capsule body, inner and outer bodies, tip covers, fittings |
Polypropylene |
KFM.K+ main combinations of pore sizes
|
Single layer filter |
Double layer filter |
||
|---|---|---|---|
|
Pore size, μm |
Ordering code |
Pore size, μm |
Ordering code |
|
0,10 |
010 |
0,20+0,20 |
020/020 |
|
0,20 |
020 |
0,45+0,20 |
045/020 |
|
0,45 |
045 |
|
|
Operational parameters
|
Mean membrane pore size, μm |
0,1 |
0,2 |
0,45 |
|
Minimal bubble point, MPa |
0,50 |
0,36 |
0,27 |
|
Initial water flow rates (for distilled water) at t=20°С, Р=0,05 МPа for filter cartridge 60 mm height для, dm3/h |
100 |
200 |
350 |
|
Maximal operational pressure, MPa |
0,4 |
||
|
Maximal differential pressure for capsules, MPa |
0,4 at 20°С; 0,1 at 60°С |
||
|
Maximal operational temperature, °C |
60 |
||
|
Effective filter area for filter cartridge 60 mm height (single layer/double layer), m2 |
0,21 / 0,175 |
||
|
Recommended change-out differential pressure, MPA (bar) |
0,24 (2,4) |
||
|
Number of sterilization cycles (autoclaving) at P=0,1 MPa и t=121 ±1°C for 45 min., at least |
5* |
||
Sterilization
Sterilization of Capsules is performed by autoclaving at temperature 121°С for 45 minutes after attainment of set-point temperature.
KFM.K+ Capsules are able to withstand at least 5 sterilization cycles by autoclaving at P = 0,1 MPa and t=121 ± 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.
Nominal dimensions
|
Height (H), mm |
Diameter (D), mm |
Filter surface area (S), m2 |
|---|---|---|
|
1000 (40") |
88 |
3 |
|
750 (30") |
88 |
2.25 |
|
500 (20") |
88 |
1.5 |
|
250 (10") |
88 |
0.75 |
|
125 (5") |
88 |
0.34 |
|
60 (2,5") |
88 |
0.14 |
For detailed instructions on operation Capsules please contact technical specialists of Technofilter RME.
Quality and Certification
All membrane filter elements used for production of KFM.K+ Capsules are subjected to wash out from organic and mechanical impurities with high-purity water and to 100% integrity control.
KFM.K+ 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 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.
KFM.K+ Capsules ordering information
|
KFM.K+ |
045/020 |
К |
60 |
|---|---|---|---|
|
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") |