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

AseptiSure® KR 5", 10", 20", 30"

mdi AseptiSure® KR cartridge filters incorporate a low protein binding PES membrane with polypropylene drainage layers to ensure pH compatibility from 1-14 making these ideal for alkaline fluid streams.

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 with biological streams.
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:
mean less addition to impurity profile of the biological product from the filters.
  • For sterile filtration of alkaline fluid streams such as pH adjusters for microbial fermentation processes. 
Construction
Membrane Hydrophilic PES
Pore size
0.2µm 0.45µm
Support Layers Polypropylene
Body and Core Polypropylene
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
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
Air Diffusion Flow (10")
< 40 ml/min @ 37 psi (2.6 Kg/cm²) with Water < 35 ml/min @ 22 psi (1.54 Kg/cm²) with Water
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 °C 55 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 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
pH Compatibility Compatible with pH range of 1 - 14
Type
AseptiSure® KR
CPKR
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) adapter and A1 (7P without fin) only

     **Size 5" is available in Adapter code A0 (7P) and A1 (7P without fin) only

     Example :

CPKR 53 01 A0 SS 1 01
Example for Non Sterile: CPKR5401A0SS101
Datasheet Download
Certificate of Quality Download