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AseptiSure KS Mini 2.5", 5"

AseptiSure KS Mini 2.5", 5"

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AseptiSure KS Mini 2.5", 5"

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AseptiSure KS Mini 2.5", 5"
  • AseptiSure KS PES membrane mini cartridge filters are serial filtration devices with a layer pore size upstream PES membrane layer to protect the downstream final PES membrane layer from premature clogging and to give enhanced throughputs, thus resulting in better economics.
  • Aseptisure KS filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications.
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. 
 
Applications:
  • Sterile liquid filtration
  • Filtration of proteinaceous liquid where minimum protein loss is desired, such as sera, culture soups and recombination proteins, antibodies etc.
  • Filtration of media, buffers etc.
  • Water filtration
Specifications:
Catalogue No LSCFL03
CONSTRUCTION
Membrane Hydrophilic PES
Final Filter Pore Size
0.2 µm 0.45 µm
Prefilter Pore Size
0.8 µm, 0.65 µm, 0.45 µm 0.65 µm, 0.8 µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point
> 50psi (3.51Kg/cm²) with Water > 30psi (2.11Kg/cm²) with Water
Microbial Retention
LRV > 7 for Brevundimonas diminuta (ATCC 19146) per cm² LRV > 7 for Serratia marcescens (ATCC 14756) per cm²
Size
Size
2.5" 5"
Effective Filtration Area (Nominal)
1000cm² 2000cm²
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
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 210.3(b)(6) 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-9001:2008 Certified
USFDA DMF No. 015554
pH Compatibility Compatible with pH range of 1 - 10 
 
Description

Details

AseptiSure KS Mini 2.5", 5"
  • AseptiSure KS PES membrane mini cartridge filters are serial filtration devices with a layer pore size upstream PES membrane layer to protect the downstream final PES membrane layer from premature clogging and to give enhanced throughputs, thus resulting in better economics.
  • Aseptisure KS filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications.
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. 
 
Applications:
  • Sterile liquid filtration
  • Filtration of proteinaceous liquid where minimum protein loss is desired, such as sera, culture soups and recombination proteins, antibodies etc.
  • Filtration of media, buffers etc.
  • Water filtration
Specifications:
Catalogue No LSCFL03
CONSTRUCTION
Membrane Hydrophilic PES
Final Filter Pore Size
0.2 µm 0.45 µm
Prefilter Pore Size
0.8 µm, 0.65 µm, 0.45 µm 0.65 µm, 0.8 µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point
> 50psi (3.51Kg/cm²) with Water > 30psi (2.11Kg/cm²) with Water
Microbial Retention
LRV > 7 for Brevundimonas diminuta (ATCC 19146) per cm² LRV > 7 for Serratia marcescens (ATCC 14756) per cm²
Size
Size
2.5" 5"
Effective Filtration Area (Nominal)
1000cm² 2000cm²
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
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 210.3(b)(6) 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-9001:2008 Certified
USFDA DMF No. 015554
pH Compatibility Compatible with pH range of 1 - 10 
 
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