UA-44035381-1
  • AseptiCap KSO-γ 5", 10", 20", 30"

AseptiCap KSO-γ 5", 10", 20", 30"

mdi AseptiCap KSO-γ are gamma sterilizable polyethersulfone membrane capsule filters offering wide pH (1-14) compatibility. These filters are specially designed for alkaline fluid streams in biopharma manufacturing processes, with added advantages of high throughputs and low hold up volumes.

These capsule filters offer serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughputs.

AseptiCap KSO-γ are validated for use in pharmaceutical and bio-pharmaceutical applications.

  • Wide pH compatibility (1-14)
  • Absolute retention
  • Low protein binding
  • Light weight and self supporting
  • Minimum cleaning requirement and low installation cost
  • Low hold up volume
  • Very high flow rates
  • 100% Integrity tested
  • Total traceability
  • Sterilization of buffers
  • Sterilization of bio-pharmaceuticals such as vaccines and therapeutic proteins
  • Sterilization of oncology drugs
Construction
Membrane Polyethersulfone
Final Filter Pore Size
0.2µm0.45µm
Filter Media Polyethersulfone Membrane
Support Layers Polypropylene
Housing Polypropylene
Integrity Testing / Retention
Bubble Point
> 50psi (3.52Kg/cm²) with Water> 30psi (2.11Kg/cm²) with Water
Max. Air Diffusion Flows (10")
< 30ml/min @ 37psi (2.60 Kg/cm²) with Water< 35ml/min @ 22psi (1.54 Kg/cm²) with Water
Size
Size
5"10" 20"30"
Effective Filtration Area (Nominal)
3000cm²6000cm²12000cm²18000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
212 mm334 mm620 mm870 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
214 mm 335 mm -- --
Dimension (End to End) - 1½" Sanitary Flange I/O
205 mm330 mm600 mm855 mm
Dimensions (End to End) - ½" Single Step Hose Barb I/O
218 mm336 mm630 mm890 mm
Dimension (End to End) - 1" Hose Barb I/O
-- 405 mm 635 mm 895 mm
Dimension (End to End) - 3/8" Hose Barb I/O
211 mm 332 mm 634 mm 885 mm
Operational
Max. Operating Temperature 80 °C @ ≤ 2 Kg/cm2
Max. Differential Pressure 4 Kg/cm2 @ 30 °C
pH Compatibility Compatible with pH range of 1-14
Sterilization Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized.
Bacterial Retention
LRV > 7 for B. diminuta ATCC 19146 per cm² of filter areaLRV > 7 for S. marcescens ATCC 14756 per cm² of filter area
Assurance
Fiber Release Complies with USFDA CFR Title 21,210.3 (b) (6)
TOC and Conductivity Meets the WFI requirements of USP <643> for Total Organic Carbon after a 3 liter WFI flush and <645> for Conductivity after a 3 liter WFI flush
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Oxidizable Substances Passes test as per USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Biosafety Passes Biological Reactivity test, In-Vivo, as per USP <88> for Class VI plastics Passes the Biological Reactivity Tests,In Vitro for Cytotoxicity as described in USP <87>
Type
AseptiCap KSO-γ (0.45 μm Upstream) LKOX
AseptiCap KSO-γ (0.8 μm Upstream) LKO5
Size
Code
5"**53
10"54
20"55
30"56
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
1½" Sanitary Flange E
3/4” Sanitary Flange***** S
3/8” Hose Barb I
Single Step ½” Hose Barb Q
1” Hose Barb**** Z
Radiation Sterilizable
Code
Yes R
No*** X
Inline/T-Line
Code
Inline X
T-Line* T
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

* T-Line Capsule filters are available with 1½” Sanitary Flange only

** 5" Capsule Filters are not available with T-Line

*** Gamma irradiated Capsule Filters cannot be gamma sterilized again

****1" Hose Barb is not available in 5" capsule filters

*****3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters


Example :

LKO5
56 01 EE X X 3 01
Example for Non Sterile: LKOX5401EERX101                                                            Example for EO Sterile: LKOX5401EEXX301

Datasheet Download
Certificate of Quality Download

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