UA-44035381-1
  • 0.1µm AseptiCap<sup>®</sup> KS 25mm, 50mm

0.1µm AseptiCap® KS 25mm, 50mm

mdi AseptiCap® KS are specially designed filters for process development and formulation development labs with identical materials of construction to larger capsule and cartridge filters for easy scale up. The 0.1µm rated PES membrane is validated for quick and efficient mycoplasma removal with enhanced throughtputs.

50mm Inline capsule filter is a specially vented device for use with peristaltic pump to ensure easy removal of entrapped air in the upstream.

Consistent and Reliable Quality:
 AseptiCap® capsule filters are produced with ISO 9001 certified quality management systems
Regulatory Compliance:
 Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Low Protein Binding:
 Results in increased overall product yield
High Throughputs:
 Translates to lower filtration costs, less number of filter changes and overall economy of operations
Low Extractables:
 Mean less addition to impurity profile of the biological product from the filters

    Sterile Filtration of:

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • Final product concentrates


Construction
Membrane 0.1 μm Hydrophilic PES
Prefilter Membrane 0.2 μm or 0.45 μm Hydrophilic PES
Plastic parts Polypropylene
Size
Size
25 mm 50 mm
Effective Filtration Area (Nominal)
5 cm²20 cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm--
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
--51 mm
Dimension (End to End) - ¼" SHB
--79 mm
Operational Radius (with Vent/ Drain)
15 mm28 mm
Integrity Testing / Retention
Bubble Point

> 26 psi (1.82 Kg/cm²) with 50% IPA

> 65 psi (4.56 Kg/cm²) with Water 
Bacterial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Operational
Max. Operating Temperature
55 °C60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C42 Psi (3 Kg/cm²) @ 30 °C
Burst Pressure
>14 Kg/cm²>8 Kg/cm²
Hold-up Volume(with air purge)
< 50 µL< 300 µL
pH Compatibility Compatible with pH range of 1-14
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 ISO 11737-1 : 2018
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 500ml flush
Particle Release Passes USP test for particulates in injections
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR Part 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

AseptiCap® KS (25mm)

Type
AseptiCap® KS (0.2μm Upstream)
 IKS1
AseptiCap® KS (0.45μm Upstream)
 IKSX
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
Female Luer lock M
Male Luer Slip N
⅛" Hose Barb H
¼" Hose Barb B
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

     Example :

IKSX 06 36 MN X X 1 04
Example for Non Sterile: IKSX0636MNXX104                                                           Example for EO Sterile: IKSX0636MNXX204

AseptiCap® KS (50mm)

Type
AseptiCap® KS (without Vent) (0.45μm Upstream)
 VKSX
AseptiCap® KS (without Vent) (0.2μm Upstream)
 VKS1
AseptiCap® KS (with Vent) (0.45μm Upstream)
 IKSX
AseptiCap® KS (with Vent) (0.2μm Upstream)
 IKS1
Size
DiaCode
50mm 10
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
¼" Stepped Hose Barb B*
¾" Sanitary Flange S*
Female Luer Lock M**
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02

   

     *¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only

    **Female luer lock is available in filters without vent only

     Example :

VKSX 10 36 SS X X 1 02
Example for Non Sterile: VKSX1036SSXX102                                                            Example for EO Sterile: VKSX1036SSXX202

Datasheet Download
Certificate of Quality Download