ClariPro® GK 5", 10", 20", 30"
mdi ClariPro® GK hydrophilic PES membrane large capsule filters are ready to use, disposable filtration devices. These are specially designed filters incorporating a microglassfiber upstream layer and a downstream PES membrane final layer and are used as pre-filters in biopharmaceuticals process development as well as manufacturing process for difficult to filter solutions.The microglassfiber layer offers high dirt holding capacity and efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions. The downstream PES membrane offers absolute retention and low protein binding along with high flow rates.
- 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 |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
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| Dimension (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Dimension (End to End) - 1" Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) - 3/8" Hose Barb I/O |
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| Vent and Drain | ¼" Hose Barb with Silicone "O" rings | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | < 60 psi (4 Kg/cm²) @ 30 °C | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minute, 25 cycles and it cannot be in-line steam sterilized | ||||
| Shelf Life | 3 years after EO 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 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 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 | ||||
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*5” capsule filters are available as inline filter only
**T-line is not available in 5” Capsule Filter
**T-line Capsule filters are available with 1½” Sanitary Flange I/O Connection Only
***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters
****1" Hose Barb is not available in 5" capsule filters
Example :
| LGKX | 54 | 04 | EE | X | T | 1 | 01 |
Example for Non Sterile: LGKX5404EEXT101 Example for EO Sterile: LGKX5404EEXT201
