UA-44035381-1
  • ClariSure<sup>®</sup> GK Mini 2.5", 5"

ClariSure® GK Mini 2.5", 5"

mdi ClariSure® GK hydrophilic PES membrane mini cartridge filters offer a microglassfiber upstream layer with a PES membrane final filter to combine high dirt holding capacities with efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions.

Consistent and Reliable Quality:
ClariSure® 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
Total Traceability
Unique identification number is laser etched on each other.
  • Precipitate removal post viral inactivation
  • Pre-filtration of cell culture media
  • Pre-filtration of serum and other viscous biologicals
  • Pre-filtration of serum solutions
  • Clarification of cell harvest supernatant
  • Pre-filtration of high value difficult to filter drug solutions
  • Polishing of turbid solutions
Construction
Pore size 0.1μm, 0.2μm, 0.5μm
Prefilter Membrane Microglassfiber
Support Layers Polyester
Body and Core Polypropylene
Size
Size
2.5" 5"
Effective Filtration Area
1000cm² 1500cm²
Materials of Construction
Filter Membrane Hydrophilic PES
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 50 psi (3.5 Kg/cm²) @ 25 °C
Sterilization Autoclavable/In-line steam sterilizable at 121 °C for 30minutes, 25 cycles
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
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
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
ClariSure® GK Mini
CGKX
Size
Size Code
2.5" 50
5" 53
Pore Size
Pore Size Code
0.1µm 36
0.2µm 01
0.5µm 04
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

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

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

      Example:

CGKX 50 04 E0 SS 1 01
Example for Non Sterile: CGKX5004E0SS101

Datasheet Download

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