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

AseptiSure KS 5", 10", 20", 30"

mdi AseptiSure KS PES membrane cartridge filters are available in a wide range of pore sizes, sizes and adaptors to suit a multitude of sterilization applications in pharmaceutical and biopharmaceuticals production processes.

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.
  • Bioburden reduction from cell harvest supernatants
  • Filtration of equilibrating, washing and elution buffers for chromatography columns
  • Sterilization of buffers
  • Sterilization of adjuvants
  • Sterilization of Large Volume Parenterals
  • Sterile filtration of WFI
Construction
Membrane Hydrophilic PES
Final Filter Pore Size
0.2 µm0.45 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 cm²LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Air Diffusion Flow (10")
< 30ml/min @ 37 psi (2.6Kg/cm²) with Water< 35ml/min @ 22 psi (1.54Kg/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)
40 lpm @ 0.70 Kg/cm² @ 27 °C55 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 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
pH Compatibility Compatible with pH range of 1 - 10
Type
AseptiSure KS (0.45µm Upstream) CPKX
AseptiSure KS (0.65µm Upstream) CPK3
AseptiSure KS (0.8µm Upstream) CPK5
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
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 Adapter Code A0 (7P) and A1 (7P without fin) only

    ***0.45µm Cartridge filters are available with 0.65µm or 0.8µm upstream layer only

     Example :

CPK5 53 01 A0 SS 1 01
Example for Non Sterile: CPK55301A0SS101

Datasheet Download
Certificate of Quality Download

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