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

0.1µm AseptiSure KS 5", 10", 20", 30"

mdi AseptiSure KS 0.1µm double layer PES membrane cartridge filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture.

The upstream PES membrane layer protects the downstream PES membrane layer from premature clogging. The membrane pore structure is specially designed to give high throughputs, thus resulting in better economics

Consistent and Reliable Quality:
AseptiSure cartridge filters are produced with ISO 9001-2008 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 and higher throughputs with biological streams.
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:
Means less addition to impurity profile of the biological product from the filters.
  • Sterile Filtration of Culture media for mammalian cell culture
Construction
Membrane Hydrophilic PES
Final Filter Pore Size 0.1µm
Prefilter Pore Size 0.2 µm or 0.45 µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 31psi (2.18Kg/cm²) with 50% IPA/Water Solution
Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm²
Air Diffusion Flow (10") < 29ml/min @ 50 psi (3.51 Kg/cm²) with Water
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure 3.5 Kg/cm² (50 psi) @ 25 °C
Reverse Pressure < 0.7 Kg/cm² (10 psi) @ 25 °C
Typical Water Flow Rates (10" Cartridge filters) 22 lpm @ 0.70 Kg/cm² @ 27 °C
Sterilization Autoclavable/In-line steam sterilizable at 121 °C for 30 minutes, 25 cycles
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 211.72 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
pH Compatibility Compatible with pH range of 1 - 10
Type
AseptiSure KS (0.2 μm Upstream) CPK1
AseptiSure KS (0.45 μm Upstream) CPKX
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
Code
0.1µm 36
Adapter
Code
7P A0
7P without fin A1
28 with fin C0
'O' D0
Elastomer
Code
Silicone SS
Viton SV
EPDM SE
FEP Encapsulated Viton FV*
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

     * FV is available in Adapter code A0(7P) and A1(7P without fin) only

     ** Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only

     Example :

CPKX 53 36 E0 SS 1 01
Example for Non Sterile: CPKX5336E0SS101
Datasheet Download
Certificate of Quality Download

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