UA-44035381-1
  • ClariSure GK 5", 10", 20", 30"

ClariSure GK 5", 10", 20", 30"

mdi ClariSure GK hydrophilic PES membrane 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
  • 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
Final Filter Membrane Hydrophilic PES
Prefilter Membrane Microglassfiber
Support Layers Polyester
Body and Core Polypropylene
Size
Size
5"10"20"30"
Effective Filtration Area (Nominal)
2500cm²5000cm²10000cm²15000cm²
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
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 CGKX
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.1µm 36
0.2µm 01
0.5µm 04
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

Example :

CGKX 56 04 A0 SS 1 01
Example for Non Sterile: CGKX5604A0SS101

Datasheet Download
Certificate of Quality Download

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