ClariPro® GK Large
MDI ClariPro® GK are lab scale hydrophilic PES membrane capsule filters are ready to use, disposable filtration devices. These are specially designed filters incorporating a microglass fiber upstream layer and a downstream PES membrane final layer and are used as pre-filters in biopharmaceutical process development laboratories for difficult to filter solutions.The microglass fiber 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 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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| 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 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″ Hose Barb and T-line are 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
Example :
| LGKX | 54 | 04 | EE | X | T | 1 | 01 |
Example for Non Sterile: LGKX5404EEXT101 Example for EO Sterile: LGKX5404EEXT201
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