UA-44035381-1
  • 0.2μm AseptiPrime KS 25mm, 50mm

0.2μm AseptiPrime KS 25mm, 50mm

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

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.

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

Sterile Filtration of :

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • Buffers
  • pH adjusters
  • Final product concentrates
  • Small volume parenterals
  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume in filters
Construction
Membrane Double layered Polyethersulfone with highly asymmetric prefilter membrane
Final Filter Pore Size 0.2μm
Prefilter Membrane 0.3μm or 0.5μm PES
Support Layers Polyester
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52 Kg/cm²)
Max. Air Diffusion Flows (10") < 29 ml/min @ 50 psi (3.52 Kg/cm²) with water
Microbial Retention LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
25 mm 50 mm
Effective Filtration Area
5 cm² 20 cm²
Dimension (End to End) - ¼" - 3/8" Stepped Hose Barb I/O
--
79 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
- 51 mm
Dimension (End to End) - ⅛" Hose Barb I/O
36 mm -
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet
23 mm -
Dimension (End to End) - ¼" Single Step Hose Barb I/O
38 mm--
Operational Radius (with Vent/ Drain)
15 mm 28 mm
Operational
Max. Operating Temperature
55°C 60°C
Max. Differential Pressure
75 psi (5 Kg/cm²) @ 25 °C 42 psi (3 Kg/cm²) @ 30 °C
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
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
pH Compatibility Compatible with pH range of 1-10

AseptiPrime KS (25mm)

Type
AseptiPrime KS (0.5μm optimized pre-filter) IKX7
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
Inlet
Connection Code
Female Luer lock M
¼” Hose Barb
B
⅛" Hose Barb
H
Outlet
Connection Code
Male Luer lock L
Male Luer Slip
N
¼” Hose Barb
B
⅛" Hose Barb
H
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

Example:

IKX7 06 01
M N X
X 1 04
Example for Non Sterile: IKX70601MNXX104          Example for EO Sterile: IKX70601MNXX204

AseptiPrime KS (50mm)

Type
Vented AseptiPrime KS-γ (0.5μm optimized pre-filter) VKX7
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange* S
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02
100 04

*In vented AseptiPrime KS ¾” Sanitary Flange is available as outlet only

Example:

VKS7 10 01 SS
X
X 1 04
Example for Non Sterile: VKX71001SSXX104          Example for EO Sterile: VKX71001SSXX204

Datasheet Download
Certificate of Quality Download

Write a review

Note: HTML is not translated!
    Bad           Good