UA-44035381-1
  • 0.2µm AseptiPrime KS  1", 2", 5", 8"

0.2µm AseptiPrime KS 1", 2", 5", 8"

mdi AseptiPrime KS are sterilizing grade PES membrane capsule filters specially designed for very high throughput.

It incorporates a highly asymmetric PES membrane prefilter to provide enhanced protection to the well proven and widely accepted sterilization grade final mdi PES membrane.

These are available in a wide range of sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development,pilot scale and production batch sizes.

AseptiPrime KS filters meet key process requirements such as absolute retention, high protein recoveries and low extractables.

  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume in filters

Sterile Filtration of:

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • Buffers
  • pH adjusters
  • Final product concentrates
  • Small volume parenterals
Construction
Final Filter Membrane 0.2µm Hydrophilic PES
Prefilter Membrane 0.5µm Asymmetric Hydrophilic PES
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/cm²) with Water
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 164 mm 215 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
91 mm 103 mm 155 mm 205 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
91 mm 110 mm 161 mm 211 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Operational Radius (with Vent/ Drain)
30 mm 65 mm 65 mm 65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure < 4 Kg/cm² (60 psi) @ 30 °C
pH Compatibility Compatible with pH range of 1-10
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30 minutes, 25 cycles and it cannot be in-line steam sterilized
Shelf Life 3 years after EO sterilization
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables
TOC/Conductivity at 25 °C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiPrime KS ( 0.5μm Asymmetric Upstream) DKX7
Size
Size
Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼" SHB A
¼" MNPT B
½" MNPT* C
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
½” Single Step Hose Barb*
Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
X
Bell
Yes**** B
No X
Bell with Cover**** C
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

**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

****Bell and bell with cover is available with:

  • ½” Hose Barb outlet connections in 1", 2", 5" and 8" Capsule filters
  • ¼" SHB outlet connection in 1" capsule filters only

Example :

DKX7 53 01 DD X X 1 01
Example for Non Sterile: DKX75301DDXX101                                                            Example for EO Sterile: DKX75301DDXX201

Datasheet Download
Certificate of Quality Download

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