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AseptiSure NS 5", 10", 20", 30"

AseptiSure NS 5", 10", 20", 30"

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AseptiSure NS 5", 10", 20", 30"

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AseptiSure NS 5", 10", 20", 30"
  • AseptiSure NS Nylon 66 membrane cartridge filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. These filters offer serial filtration for enhanced throughput. The upstream layer is of larger pore size to protect the downstream final filtration layer.
Features:
  • Absolute Retention
  • Wide Chemical Compatibility
  • 100% Integrity Tested
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.
Total Traceability
 Unique identification number is laser etched on each other. 
 
Applications:
  • Sterilization of compatible solvents and chemicals
  • Filtration of rinse water for endoscopes
Specifications:
Catalogue No LSCFL24
CONSTRUCTION
Membrane Nylon 66
Final Filter Pore Size
0.2µm 0.45µm
Prefilter Pore Size
0.8 μm, 0.45 μm 0.8µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm² Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow (with 50% IPA Wetted)
< 25ml/min @ 16 psi (1.12Kg/cm²) < 25ml/min @ 10 psi (0.7Kg/cm²)
Size
Size
5" 10" 20" 30"
Effective Filtration Area
3000cm² 6000cm² 12000cm² 18000cm²
OPERATIONAL
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi) 
Max. Differential Pressure < 3.5Kg/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 @ Δp= 5psi (0.3kg/cm²)
ASSURANCE
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
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 
 
 
Description

Details

AseptiSure NS 5", 10", 20", 30"
  • AseptiSure NS Nylon 66 membrane cartridge filters are sterilizing grade filters offering absolute retention and wide chemical compatibility. These filters offer serial filtration for enhanced throughput. The upstream layer is of larger pore size to protect the downstream final filtration layer.
Features:
  • Absolute Retention
  • Wide Chemical Compatibility
  • 100% Integrity Tested
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.
Total Traceability
 Unique identification number is laser etched on each other. 
 
Applications:
  • Sterilization of compatible solvents and chemicals
  • Filtration of rinse water for endoscopes
Specifications:
Catalogue No LSCFL24
CONSTRUCTION
Membrane Nylon 66
Final Filter Pore Size
0.2µm 0.45µm
Prefilter Pore Size
0.8 μm, 0.45 μm 0.8µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Microbial Retention
Brevundimonas diminuta (ATCC 19146) per cm² Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow (with 50% IPA Wetted)
< 25ml/min @ 16 psi (1.12Kg/cm²) < 25ml/min @ 10 psi (0.7Kg/cm²)
Size
Size
5" 10" 20" 30"
Effective Filtration Area
3000cm² 6000cm² 12000cm² 18000cm²
OPERATIONAL
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi) 
Max. Differential Pressure < 3.5Kg/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 @ Δp= 5psi (0.3kg/cm²)
ASSURANCE
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
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 
 
 
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