UA-44035381-1
  • AseptiSure NS Mini 2.5", 5"

AseptiSure NS Mini 2.5", 5"

mdi Aseptisure NS Nylon 66 membrane mini 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
  • Sterilization of disinfecants in pharmaceutical labs and process areas
  • Filtration of hospital disinfectants
  • Filtration of rinse water for endoscopes and other hospital equipments
  • Sterilizing filtration of pharmaceutical, aqueous and nonaqueous solutions
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
Bubble Point (with water)
> 50psi (3.51Kg/cm²) with Water> 30psi (2.11Kg/cm²) with Water
Size
Size
2.5" 5"
Effective Filtration Area
1000cm² 2000cm²
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 Mini
(0.45µm Upstream)
CPNX
AseptiSure NS Mini
(0.8µm Upstream)
CPN5
Size
Code
2.5" 50
5" 53
Pore Size
Code
0.2µm 01
0.45µm* 02
Adapter
Code
4463 E0
4463B H0
4440 U0
Seal-K
G0**
Seal-O
F0***
Seal-M
J0
Elastomer
Code
Silicone SS
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

*0.45µm cartridge filter are available with 0.8µm upstream layer only

**G0 adapter code is not available with any elastomer. Pleasemention XX in place of elastomer code while ordering

***Adapter code F0 is available only in 5” cartridge filters

      Example :

CPNX 50 01 E0 SS 1 01
Example for Non Sterile: CPNX5001E0SS101

Datasheet Download
Certificate of Quality Download

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