UA-44035381-1
  • 0.1μm AseptiPrime KS 5", 10", 20", 30"

0.1μm AseptiPrime KS 5", 10", 20", 30"

mdiAseptiPrime KS are sterilizing grade PES membrane large capsule filters specially designed for very high throughputs. The special asymmetric pre-filter membrane layer with high asymmetric proportion offers high loading and volume handling capacities to provide enhanced protection to the final membrane layer.

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.

These filters meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility etc.

  • 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
Membrane Hydrophilic PES
Final Filter Pore Size 0.1 μm
Prefilter Membrane 0.3μm or 0.5μm PES
Support Layers Polyester
Integrity Testing / Retention
Bubble Point >31psi (2.18 Kg/cm²) with 50% IPA/ Water Solution
Max. Air Diffusion Flows (10") < 29 ml/min @ 50 psi (3.52 Kg/cm²) with water
Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm²
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Dimension (End to End) - 1½" Sanitary Flange I/O
207 mm 326 mm 601 mm 876 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
217 mm 332 mm 607 mm 882 mm
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
203 mm 332 mm 607 mm 882 mm
Operational Radius (with Vent/ Drain)
78 mm 78 mm 78 mm 78 mm
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
pH Compatibility Compatible with pH range of 1-10
Sterilization By Gas Sterilization 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
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush
Indirect Food Additive Comply with USFDA 21 CFR Part 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiPrime KS (0.3μm Upstream) LKX9
AseptiPrime KS (0.5μm Upstream) LKX7
Size
Length
Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
Single Step ½” Hose Barb Q
1½" Sanitary Flange E
3/8” Hose Barb I
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 is not available in 5" Capsule filter

*T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections Only


Example:

LKX7 54 36 EE X
T 1 01

Example for Non Sterile: LKX75336QQXX101               Example for EO Sterile: LKX75336QQXX201


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