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

AseptiCap KSO 5", 10", 20", 30"

mdi AseptiCap KSO are polyethersulfone membrane capsule filters offering wide pH (1-14) compatibility. These filters are specially designed for alkaline fluid streams in bio-pharma manufacturing processes, with added advantage 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 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
  • Scale up of new drug delivery systems
  • Bioburden removal from cell harvest supernatants
  • Sterilization of bio-pharmaceuticals such as vaccines and therapeutic proteins
  • Sterilization of oncology drugs
  • Sterilization of buffers
Construction
Membrane Polyethersulfone
Final Filter Pore Size
0.2µm0.45µm
Prefilter Pore Size
0.45µm0.8µm
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
203 mm332 mm618 mm878 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
212 mm 345 mm -- --
Dimension (End to End) - 1½" Sanitary Flange I/O
207 mm326 mm605 mm865 mm
Dimensions (End to End) - ½" Single Step Hose Barb I/O
217 mm332 mm628 mm888 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 330 mm 618 mm 878 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 By Gas Sterilization by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125° C for 30 minutes, 25 cycles, cannot be 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 (0.45 μm Upstream) LKOX
AseptiCap KSO (0.8 μm Upstream) LKO5
Size
EFA Code
5"** 3000 cm253
10" 6000 cm254
20" 12000 cm255
30" 18000 cm256
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
X
Inline/T-Line
Code
Inline X
T-Line* T
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

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

** 5" Capsule Filter is available in in-line capsule filters only

***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 2
01
Example for Non Sterile: LKO55601EEXX101                                                            Example for EO Sterile: LKO55601EEXX201

Datasheet Download
Certificate of Quality Download

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