ClariPro® GK-γ Small
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 throughput
- 100% integrity tested
- Low protein binding
- High flow rates
- Biologically Inert
- Easy Installation
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving or Ethylene Oxide
- 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 |
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| Effective Filtration Area (Nominal) |
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| Dimensions (End to End) – 1½” Sanitary Flange I/O |
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| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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| Dimensions (End to End) – ¾” Sanitary Flange I/O |
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| Dimension (End to End) – ⅛” Hose Barb I/O |
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| Dimension (End to End) – ½” Single Step Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” ring | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30° C | ||||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| 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 as per USP <85> | ||||
| 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 | ||||
| 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 NVR test as per USP <661> | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Oxidizable Substances | Passes test as per USP <1231> | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1” Capsule Filters are not available with ½” Single step Hose Barb and ½” MNPT
**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
a: Gamma sterilized filters cannot be gamma irradiated again
b: Bell and bell with cover is available with :
- ½” HB outlet connections in 1”, 2”, 5” and 8” capsule filters
- ¼” SHB outlet connection in 1” capsule filters only
Example :
| DGKX | 57 | 04 | DD | R | X | 1 | 01 |
Example for Non Sterile: DGKX5704EERX101
Example for Gamma Sterile: DGKX5704EEXX301
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