UA-44035381-1
  • ClariPro GK-γ 25mm, 50mm

ClariPro GK-γ 25mm, 50mm

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 biopharmaceutical process development laboratories 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
25mm50mm
Effective Filtration Area (Nominal)
5cm²20cm²
Dimension (End to End) - ¾" Sanitary Flange I/O
-- 51 mm
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet
23 mm --
Operational Radius (with Vent/ Drain)
15 mm 28 mm
Operational
Max. Operating Temperature
55 °C60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C42 Psi (3 Kg/cm²) @ 30 °C
Burst Pressure >8 Kg/cm²
Sterilization By Autoclave Autoclavable at 125°C for 30minutes, 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 <88> 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
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

ClariPro GK-γ 25mm

Type
ClariPro GK- γ IGKX
Size
Dia
Code
25mm 06
Pore Size
Pore Size
Code
0.1µm 36
0.2µm 01
0.5µm 04
I/O Connection
Connection Code
Female Luer Lock M
Male LuerSlip N
⅛" Hose Barb H
¼" Hose Barb B
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
100 04

Example :

IGKX 06 04 MN R X 1 04
* Gamma sterilized filters cannot be gamma irradiated again

Example for Non Sterile: IGKX0604MNRX104          Example for Gamma Sterile: IGKX0604MNXX304

ClariPro GK-γ 50mm

Type
ClariPro GK-γ
VGKX
Size
Dia
Code
50mm 10
Pore Size
Pore Size
Code
0.1µm 36
0.2µm 01
0.5µm 04
I/O Connection
Connection Code
¼” SHB B
¾" Sanitary Flange** S
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

Example :

VGKX 10 04 BB X X 1 02
*Gamma sterilized filters cannot be gamma irradiated again

**¾" Sanitary Flange is available as Outlet only

Example for Non Sterile: VGKX1004BBRX102          Example for Gamma Sterile: VGKX1004BBXX302

Datasheet Download

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