UA-44035381-1
  • AseptiSure<sup>®</sup> NS 5", 10", 20", 30"

AseptiSure® NS 5", 10", 20", 30"

mdi 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.

  • 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.
  • Sterilization of compatible solvents and chemicals
  • Filtration of rinse water for endoscopes
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
Size
Size
5"10"20"30"
Effective Filtration Area
3000cm² 6000cm² 12000cm² 18000cm²
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)
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 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
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
Type
AseptiSure® NS (0.45µm Upstream) CPNX
AseptiSure® NS (0.8µm Upstream) CPN5
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
 Code
0.2µm 01
0.45µm***
 02
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 Code A0 (7P) and A1 (7P without fin) only

***0.45µm Cartridge filters are available with 0.8µm upstream layer only.

Example :

CPN5 55 01 A0 SV 1 01
Example for Non Sterile: CPN55501A0SV101

Datasheet Download
Certificate of Quality Download

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