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AseptiSure<sup>®</sup> KR Standard

AseptiSure® KR Standard

MDI AseptiSure® KR mini 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.

  • Low protein binding
  • High throughputs
  • Long service life
  • Pre-flushed to minimize particulate release after installation
  • Non-toxic material of construction
  • Multiple autoclavable/SIP
  • Absolute retention
  • 100% integrity tested
  • High flow rates
  • Bioburden maintained below 1000 cfu/device
  • Endotoxin level certified to be <0.25 EU/ml
  • Unique identification number is laser etched on each filter
  • Individual certificate of quality for each device
  • Sterilizable by Autoclaving/Steaming in place (SIP)

  • 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
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″)
< 30 ml/min @ 37 psi (2.6 Kg/cm²) with Water < 35 ml/min @ 22 psi (1.54 Kg/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
Assurance
Sterilization Autoclavable/In-line steam sterilizable at 121° C for 30 minutes, 25 cycles
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
Typical Water Flow Rates (10″ Cartridge filters)
40 lpm @ 0.70 Kg/cm² @ 27 °C 55 lpm @ 0.70 Kg/cm² @ 27 °C

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

File Type Download
Datasheet Download
COQ Download

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