UA-44035381-1
  • AseptiCap KSO 1", 2", 5", 8"

AseptiCap KSO 1", 2", 5", 8"

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
  • 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
Size
Size
1"2" 5"8"
Effective Filtration Area (Nominal)
250cm²500cm²1000cm²2000cm²
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--111 mm162 mm212 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
91 mm110 mm161 mm211 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
--115 mm165 mm217 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Vent and Drain ¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
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)* DKOX
AseptiCap KSO (0.8 μm Upstream) DKO5
Size
EFA Code
1" 100 cm231
250 cm251
2" 500 cm252
5" 1000 cm253
8" 2000 cm257
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼" SHB A
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½” Hose Barb** Q
Female Luer Lock U
Male Luer Slip*** W
3/8" Hose Barb** I
3/16" Hose Barb**** N
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

**1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb

***Male luer slip is available only in 1” capsule filter as outlet

****3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

Example :

DKOX 52 01 EE X X 1 01
Example for Non Sterile: DKOX5701DDXX101                                                            Example for EO Sterile: DKOX5701DDXX201

Datasheet Download
Certificate of Quality Download

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