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

0.1µm AseptiCap KS 5", 10", 20", 30"

mdi AseptiCap KS PES membrane large capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalin cell culture.

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
Support Layers Polyester
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 31psi with 50% IPA/water solution
Max. Air Diffusion Flow (@ 50psi (3.51 Kg/cm²) with water)
< 15 ml/min< 29 ml/min< 58 ml/min< 87 ml/min
Bacterial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
203 mm 332 mm 607 mm
882 mm
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange I/O
207 mm 326 mm 601 mm 876 mm
Dimensions (End to End) Inline Capsule Filters - ½" Single Step Hose Barb I/O
217 mm 332 mm 607 mm 882 mm
Clean Water Flow Rate @ 10 psi with 1½" Sanitary Flange connection
8 lpm 17 lpm 29 lpm 45 lpm
Operational Radius (with Vent/ Drain)
78 mm 78 mm 78 mm 78 mm
Vent and Drain ¼" Hose Barb with Silicone "O" rings
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 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
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush
Particle Release Passes USP test for particulates in injectables
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes NVR test as per USP <661>
Oxidizable Substances Within limits as specified in USP <1231>
Particle Shedding Passes USP test for particulates in injectables.
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiCap KS (0.2 μm Upstream) LKS1
AseptiCap KS (0.45 μm Upstream) LKSX
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
1½" Sanitary Flange E
3/8” Hose Barb** I
Single Step ½”Hose Barb Q
1” Hose Barb Z
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 filter are available with 1½" Sanitary Flange I/O connection only

    ** 3/8" Hose Barb is available only with inline capsule filters

     Example:

LKSX 54 36 EE X X 1 01
Example for Non Sterile: LKSX5436EEXX101                                                            Example for EO Sterile: LKSX5436EEXX201

Datasheet Download
Certificate of Quality Download

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