UA-44035381-1
  • ClariPro GK-γ 1", 2", 5", 8"

ClariPro GK-γ 1", 2", 5", 8"

mdi ClariPro GK- γ gamma sterilizable hydrophilic PES membrane capsule filters are ready to use, disposable filtration devices. These filters are specially designed filters incorporating a microglassfiber upstream layer and a downstream PES membrane layer and are used as pre-filters in biopharmaceuticals process development as well as manufacturing processes for difficult to filter solutions.

  •  High Flow Rates
  •  High Throughput
  •  Very High Retention
  •  Low Protein Binding
  •  Compact Design
  • Precipitate removal post viral inactivation
  • Pre-filtration of serum solutions
  • Clarification of cell harvest supernatants
  • Polishing of turbid solutions
Construction
Membrane Hydrophilic PES
Pore size 0.1µm, 0.2µm, 0.5µm
Prefilter Membrane Microglassfiber
Support Layers Polyester
Body and Core Polypropylene
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
150cm²500cm²1000cm²1500cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
91 mm 110 mm 161 mm 211 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
91 mm 103 mm 155 mm 205 mm
Dimension (End to End) - ⅛" Hose Barb I/O
90 mm 112 mm 164 mm 215 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Operational Radius (with Vent/ Drain)
30 mm 65 mm 65 mm 65 mm
Vent and Drain ¼" Hose Barb with Silicone "O" ring for 2", 5" and 8" capsule filters
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure < 60 psi (4 Kg/cm²) @ 30° C
Sterilization By Autoclave Autoclavable at 125°C for 30minute, 1 cycle after gamma irradiation and it cannot be in-line steam sterilized
Sterilization By Irradiation Gamma Irradiatable up to 50 kGy
Shelf Life 2 years after gamma sterilization
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
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
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
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
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
ClariPro GK-γ DGKX
Size
Size Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size
Code
0.1µm 36
0.2µm 01
0.5µm 04
I/O Connection
Connection Code
¼” SHB A
¼" MNPT B
½” MNPT* C
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½" Hose Barb* Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
Radiation Sterilizable
Code
Yes R
No**** X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb

**Male luer slip is available only in 1” capsule filter as outlet

***3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

**** Gamma sterilized filters cannot be gamma irradiated again

     Example :

DGKX 57 04 DD R X 1 01
Example for Non Sterile: DGKX5704EERX101          Example for Gamma Sterile: DGKX5704EEXX301

Datasheet Download
Certificate of Quality Download

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