UA-44035381-1
  • 0.2μm AseptiCap<sup>®</sup> KSO 1", 2", 5", 8"

0.2μm 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 0.2µm
Prefilter Pore Size 0.45µm
Support Layers Polypropylene
Housing Polypropylene
Size
Size
1"2" 5"8"
Effective Filtration Area (Nominal)
250cm²500cm²1000cm²2000cm²
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm162 mm214 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--112 mm165 mm216 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
85 mm104 mm155 mm206 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
92 mm112 mm164 mm216 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
--115 mm162 mm218 mm
Operational Radius (with Vent/ Drain)
40 mm65 mm65 mm65 mm
Vent and Drain ¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/cm²) with Water
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 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
I/O Connection
Connection Code
¼" SHB A
¼” MNPT (18 TPI) B
¼” BSP (19 TPI) M
¼” BSP (19 TPI) with O-ring P
¼” BSP F
½” MNPT C
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

AseptiCap KSO Small flow rates

Datasheet Download
Certificate of Quality Download